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Oculir Raises $7.3 Million in Series A Financing; Top-Tier Investment Syndicate Led by Onset Ventures and CHL Medical Partners Includes Canaan Partners, Three Arch Partners, Shepherd Ventures and Windamere Venture Partners.
San Diego, CA – December 7, 2005
Oculir, Inc., developing the first commercial non-invasive glucose testing system for people with diabetes, announced today that it has raised $7.3 million in a Series A preferred financing. This first round of venture capital investment was led by Onset Ventures and CHL Medical Partners. Other investors include Canaan Partners, Three Arch Partners, Shepherd Ventures and Windamere Venture Partners.
"Since its initial seed funding two years ago, Oculir has developed and demonstrated an innovative product concept that has the potential to provide significant benefits to the large population of people with diabetes. This type of innovation represents exactly what we seek for companies in our portfolio," commented Leslie Bottorff, General Partner with Onset Ventures.
“The founders of Oculir have combined the best wavelength region for measuring glucose, the Mid-IR, with a unique measurement site, the white of the eye, and protected it with a strong intellectual property position,” noted Dr. Myles Greenberg, General Partner with CHL Medical Partners.
Joining Ms. Bottorff and Dr. Greenberg on the Oculir Board of Directors are Ms. Wende Hutton from Canaan Venture Partners, Scott Glenn of Windamere Venture Partners, Michael Walsh as Chairman and the company’s founder, Dr. John Burd.
“Oculir is very pleased to have such strong financial backing to assure our continued rapid progress to bring our novel non-invasive glucose testing product to fruition. The funds from this financing will be used to continue the development of our commercial device and perform expanded human clinical trials. People with diabetes have been waiting for a true non-invasive glucose testing system for over 20 years, and we are eager to deliver such a system,” stated Dr. John Burd, President & CEO.
About Diabetes
People with diabetes cannot adequately control their blood sugars without proper treatment which may include diet and exercise, various oral medications and/or insulin injections. According to the American Diabetes Association, over 15 million individuals in the US have diabetes. Fortunately, if the disease is properly treated, individuals with diabetes can avoid the complications of diabetes which include blindness, kidney failure and increased risk of cardiovascular disease. Today, individuals with diabetes must prick their fingers to obtain a sample of blood for measuring their blood glucose levels.
About Oculir
Oculir, Inc. is a privately held, venture-backed medical device company based in San Diego, CA. Oculir was founded in 2003 with seed funding from its founders and Windamere Venture Partners to develop a non-invasive glucose testing system for people with diabetes. In addition to glucose, the testing platform being developed by Oculir has the potential to non-invasively measure a variety of important medical analytes.
Millennium Pharmacy Systems Completes $14.5 Million Financing
Wexford, PA – November 17, 2005
Millennium Pharmacy Systems, a privately-held healthcare company providing contract pharmacy services to the long-term care industry, announced the recent completion of a $14.5 million equity financing. CHL Medical Partners led the capital raise and was joined by Boulder Ventures. Both firms are new investors in the Company.
"We are pleased to complete this major round of financing and to accelerate the growth of our innovative business, and we believe that the MPSRx system is now poised to improve the standard of medication management in the nursing home," said Gary Duty, President and Chief Executive Officer of MPS. Mr. Duty co-founded MPS in July 2000 with William Gatti and Steven Brody, successful entrepreneurs in the institutional pharmacy and long-term care businesses. The senior management team also includes Lena Sturgeon, a seasoned long-term care pharmacy and skilled nursing facility executive, as Chief Operating Officer.
"We are excited about MPS' demonstrated ability to improve both the care of nursing home patients and the efficiency of the customer facility, and we are pleased to join this proven team of entrepreneurs and managers," said Myles Greenberg, a Partner at CHL Medical Partners, who joined the MPS Board of Directors in connection with this financing.
In addition to Dr. Greenberg, the company's current Board has been expanded to include Jonathan Perl, a Partner at Boulder Ventures.
About Millennium Pharmacy Systems, Inc.
Millennium Pharmacy Systems is a pioneer in the field of medication management systems for the long term care industry. The company utilizes advanced information handling technologies and informatics-driven logistics to provide a virtually error-free environment for managing and administering medications for residents of nursing home facilities.
Phase I Clinical Studies Demonstrate Safety and Initial "Proof of Concept" for Amicus Therapeutics' Fabry Disease Drug;
Lead Compound Based on Unique Pharmacological Chaperone Technology to Correct Misfolded Proteins Demonstrates Positive Biological Activity in Healthy Volunteers; Amicus Initiates Phase II Clinical Program
Cranbury, NJ – September 8, 2005
Amicus Therapeutics, a biopharmaceutical company developing small molecule, orally-active pharmacological chaperones for the treatment of human genetic diseases, today announced positive results from Phase I clinical studies of its lead compound AmigalTM (migalastat hydrochloride) that is being developed using an entirely new approach for the treatment of Fabry disease. Based on these results in healthy volunteers, the company has commenced a Phase II clinical program to study Amigal in patients with Fabry disease. The Amicus executive team discussed the findings at the 42nd Annual Symposium of the Society for the Study of Inborn Errors of Metabolism held this week in Paris.
Amicus' technology represents a unique approach to treating the enzyme deficiency (alpha galactosidase A) that characterizes Fabry disease. Amigal acts as a pharmacological chaperone that restores natural function to the misfolded target protein – in this case the defective enzyme. In the Phase l studies, administration of Amigal to 16 healthy volunteers resulted in the following:
- Zero drug related adverse events
- High bioavailability in an oral formulation, and
- A favorable pharmacokinetic profile as measured by multiple parameters.
Notably, administration of Amigal also resulted in a statistically significant and dose-dependent increase in the activity of the target enzyme in each of the healthy volunteers who took part in the study.
“These exciting results are the first proof of concept for Amicus' unique pharmacological chaperone technology that offers the potential to dramatically improve treatment options for patients with genetic diseases,” said Michel Bouvier, Ph.D., professor and director of biochemistry at the University of Montreal and a member of Amicus' Scientific Advisory Board. ”The demonstration of increased enzyme activity in the healthy volunteers is intriguing. If these data are replicated, pharmacological chaperones may be applicable to therapeutic indications beyond the specific genetic disorders targeted today.”
“This is a potentially groundbreaking advance that may transform the way we treat a wide range of genetic diseases,” said Arthur Horwich, M.D., professor of genetics and pediatrics at Yale University and a member of Amicus' Scientific Advisory Board. “This unique technology represents a paradigm-shifting approach to the management of genetic diseases. If these data are confirmed in further clinical studies of Fabry patients, Amicus' pharmacological chaperone technology could allow us to move beyond the blunt approach of trying to replace missing proteins, and instead use an oral therapy to marshal the patients' own natural resources to correct defects in their innate protein production mechanism.”
Based on these positive results, Amicus has initiated a Phase ll clinical program for Amigal in Fabry disease. The Phase II program includes investigational sites in the United States, Europe and Latin America and is designed to study the safety and preliminary efficacy of Amigal in Fabry patients. The first patient was enrolled August 31, 2005 and preliminary results are expected in early 2006. Amicus is also proceeding with several other programs, including a novel small molecule treatment for Gaucher disease, AT2101.
About Fabry Disease
Fabry disease is an inherited genetic disease caused by diminished or absent levels of a key enzyme called a-galactosidase A (a-GAL). In most Fabry patients, missense mutations alter the structure of a-GAL, which results in the degradation of the protein before it is allowed to leave the endoplasmic reticulum. As a result, a-GAL is unable to reach the lysosome – the area of the cell where the enzyme does its work. Reduced or absent levels of a-GAL activity leads to the accumulation of a complex lipid called globotriaosylceramide (GL-3) in the affected cells. The accumulation of GL-3, as well as the increased cell burden caused by the misfolding and accumulation of the a-GAL protein, leads to disease in the central nervous system, heart, kidneys and skin. Patients with Fabry disease experience pain, clouded vision, kidney failure and have an increased risk of heart attack and stroke. Fabry disease affects approximately 5,000 people worldwide but recent evidence suggests that the disease may be significantly under-diagnosed. Pharmacological chaperones offer several potential advantages over competing approaches to the treatment of genetic disorders, including oral delivery and the ability to increase enzyme activity in hard to reach areas like the central nervous system.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company based in Cranbury, New Jersey, developing small molecule, orally-active pharmacological chaperones for the treatment of human genetic diseases. Many of these diseases are the result of missense and other genetic errors that cause the misfolding and degradation or accumulation of a particular protein. Amicus' products act as pharmacological chaperones that selectively bind and “rescue” the misfolded target protein to restore its proper conformation and natural function, which in turn restores the function of the affected cells. Amicus' lead compound Amigal™ is in Phase II clinical trials for Fabry disease. The company has an active drug development program for Gaucher disease and is developing programs for a range of genetic diseases.
Amicus Therapeutics Raises $55 Million Series C Financing;
New Funds to Accelerate Development of Unique Pharmacological Chaperones to Correct Misfolded Proteins
Cranbury, NJ – September 8, 2005
Amicus Therapeutics, a biopharmaceutical company developing small molecule, orally-active pharmacological chaperones for the treatment of human genetic diseases, today announced the closing of a $55 million Series C financing. The company intends to use the proceeds to advance its drug pipeline based on the company's unique technology that has the potential to transform the treatment of human genetic diseases. Amicus' lead compound Amigal™ (migalastat hydrochloride) is in a Phase ll clinical program for Fabry disease. All of Amicus' current investors participated in the Series C round, which was led by new investor Quaker BioVentures.
“Amicus has truly exciting technology that has breakthrough potential for the treatment of devastating genetic diseases,” said Sherrill Neff, managing partner of Quaker BioVentures. “We welcomed the opportunity to join Amicus' current investors and lead this financing as the company continues to advance. Amicus will soon have two promising compounds in clinical trials based on its pharmacological chaperone technology, and with this new financing the company is well positioned to continue to ramp up its multiple drug development activities.”
Quaker BioVentures led the Series C financing, joined by existing investors Canaan Partners, CHL Medical Partners, Frazier Healthcare Ventures, New Enterprise Associates, Prospect Venture Partners and Radius Ventures. Other new investors include Palo Alto Investors and the Garden State Life Sciences Venture Fund, which is funded by the New Jersey Economic Development Authority (NJEDA) and managed by Quaker BioVentures. Mr. Neff of Quaker BioVentures is joining the Amicus Board of Directors.
“As an early and now repeat investor in Amicus, we are most pleased and impressed with the company's achievement of several significant milestones in just the past nine months. The momentum at Amicus is simply remarkable and reflects the breadth and depth of its core technology as well as the commitment and passion of its now 35 employees,” said Michael Raab, a partner at New Enterprise Associates and an Amicus board member.
“At Amicus, we are building momentum in human genetic diseases,” said John F. Crowley, chairman and chief executive officer of Amicus. “We look forward to applying these new financial resources to advance our lead compound, Amigal, and to accelerate the growing momentum of our preclinical programs. We are optimistic that our passion and commitment to this field will rapidly translate into effective therapies for the many individuals who live with these life threatening disorders.”
Separately, Amicus today announced positive results from its Phase l clinical studies of Amigal and the start of patient enrollment in its Phase ll clinical program for the treatment of Fabry disease. In addition to meeting all of its safety endpoints, the Phase l studies demonstrated proof of concept for Amicus' pharmacological chaperone technology, showing that Amigal has the ability to increase target enzyme activity levels, even in healthy individuals.
Amicus' second product candidate, AT2101, a treatment for Gaucher disease, is in late stage preclinical development with clinical trials expected to commence in the first half of 2006. The company also is advancing its pipeline of earlier stage pharmacological chaperone compounds for a variety of human genetic disorders.
Amicus recently moved into a new 40,000 square foot, state-of-the-art business and science headquarters facility in Cranbury, NJ.
"Amicus represents another success story for the thriving New Jersey biotechnology sector and we are very pleased the Garden State Life Sciences Venture Fund is participating in this financing," said Caren Franzini, chief executive officer of the NJEDA. "Amicus is a graduate of the EDA's Commercialization Center for Innovative Technologies in North Brunswick, and we believe the company epitomizes the innovation, entrepreneurial savvy and industry expertise that are making our state such an attractive location for this critically important sector."
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company based in Cranbury, New Jersey, developing small molecule, orally-active pharmacological chaperones for the treatment of human genetic diseases. Many of these diseases are the result of missense and other genetic errors that cause the misfolding and degradation or accumulation of a particular protein. Amicus' products act as pharmacological chaperones that selectively bind and “rescue” the misfolded target protein to restore its proper conformation and natural function, which in turn restores the function of the affected cells. Amicus' lead compound Amigal™ is in Phase II clinical trials for Fabry disease. The company has an active drug development program for Gaucher disease and is developing treatments for a range of human genetic diseases.
GeneOhm Sciences Announces Evanston Northwestern Healthcare System MRSA Testing Program; World Class Healthcare Institution Initiates Testing Program
San Diego, CA – September 1, 2005
GeneOhm Sciences, an emerging leader in
molecular diagnostics, is pleased to announce that the Evanston Northwestern Healthcare
(ENH) system has selected GeneOhm’s IDI-MRSA™ assay for use in a comprehensive,
hospital-wide admission screening program to detect colonization by Methicillin-resistant Staphylococcus aureus (MRSA). This first-of-its-kind program in the U.S. will assess all
admissions to the hospital for determination of colonization with MRSA. The IDI-MRSA™ assay is currently in use at numerous leading institutions in the US, Canada, UK,
and Europe.
Evanston Northwestern Healthcare is a leader in advancing medicine to improve patient
care. The group has been screening high-risk patients for the past two years and has
selected GeneOhm’s rapid molecular-based method for expansion of the testing of
admissions. The three-hospital wide program will identify those patients who are colonized
with MRSA almost immediately on admission, allowing physicians and staff to provide the
best and most immediate treatment opportunities for the patient.
MRSA is a drug-resistant form of a pathogen S. aureus, which is a major cause of infection
in both healthcare and community settings. MRSA infections have been shown to cause
substantial illness and longer hospital stays. Having definitive results for MRSA in hours
instead of days allows aggressive transmission prevention and treatment measures to begin
almost immediately, significantly reducing the opportunity for spread in the hospital
population while improving patient outcomes and enabling better control of the costs of
infections.
“Evanston Northwestern is dedicated to protecting our patients and healthcare workers
from MRSA. We are committed to addressing MRSA head-on; determining the MRSA
status of a patient at admission allows our institutions to provide the best and most costeffective
care possible,” commented Lance Peterson, MD, FASCP, Epidemiologist and
Director of Clinical Microbiology and Infectious Disease Research at Evanston
Northwestern Healthcare, and Professor of Pathology and Medicine at Northwestern
University’s Feinberg School of Medicine.
“Evanston Northwestern Healthcare is taking a leading role in reducing MRSA and promoting
patient safety. We are pleased that they have chosen our rapid molecular assay as a key tool in
this important effort.” commented Dr. Peter Klemm, President and CEO of GeneOhm
Sciences.
About GeneOhm Sciences, Inc.
GeneOhm Sciences is a molecular diagnostic company with locations in San Diego, CA
and Quebec City, Quebec, Canada. Its current commercial product portfolio includes two
rapid, amplified nucleic acid-based assays cleared by the FDA, Health Canada and bearing
the CE mark: the IDI-Strep B™ Assay for rapid detection of Group B Streptococcus and
the IDI-MRSA™ Assay for rapid detection of methicillin-resistant Staphylococcus aureus directly from clinical specimens. These products are the first molecular-based diagnostic
products cleared by the FDA which meet the specifications required to replace standard culture methods. Future products include assays to detect vancomycin resistance and
combined MRSA/methicillin-sensitive Staphylococcus aureus. GeneOhm’s future product
pipeline is based on the company’s broad portfolio of molecular-based technology for
processing and detecting nucleic acids from a variety of specimens. These diagnostic
products will serve unmet needs in a wide range of diseases, including infectious diseases,
inherited diseases and oncology.
GeneOhm Sciences Announces Year Long MRSA Study in the United Kingdom; Birmingham Hospitals Lead the Way in Rapid Proactive Testing
San Diego, CA – August 22, 2005
GeneOhm Sciences, an emerging leader in molecular-based diagnostics, is pleased to announce the beginning of a year-long pilot study, commissioned by the UK Department of Health, of proactive patient screening to detect colonization by methicillin-resistant Staphylococcus aureus (MRSA). The program, which will be implemented at Birmingham Heartlands and Solihul NHS Trust in Birmingham, UK, will include testing approximately 10,000 patients using GeneOhm’s IDI-MRSA™ rapid, molecular-based screening assay for identification of MRSA directly from patient specimens. The IDI-MRSA assay is currently in use at numerous leading institutions in the UK, Europe and North America.
Birmingham Heartlands and Solihul NHS Trust, two progressive hospitals in the UK, currently screen patients on admission for MRSA, but the medical staff waits 48 hours or more for results coming from tests based on the traditional culture methods used. This delay means that patients carrying MRSA are not identified until two to three days after they are in a ward. The IDI-MRSA assay system can detect MRSA in less than two hours directly from the patient specimen.
MRSA is a drug-resistant form of the pathogen S. aureus, which is a major cause of infection in both healthcare and community settings. MRSA infections have been shown to cause substantial illness and longer hospital stays. Having definitive results for MRSA in hours instead of days allows proper treatment to begin almost immediately, significantly improving outcomes while enabling institutions to better control overall costs of infections. “We believe it is essential to take an active role in protecting our patients and healthcare workers from MRSA. Detecting MRSA earlier allows our institutions to provide the best and most cost-effective care possible,” commented Professor Peter M. Hawkey, Professor of Clinical & Public Health Bacteriology at the Health Protection Agency, West Midlands Public Health Laboratories. “In initiating this study, the Birmingham hospitals are taking a leading role in reducing MRSA. We are honored to have been selected to participate in this important and pivotal study. We are confident that the earliest possible identification of MRSA carriers can significantly enhance the effectiveness and quality of patient care while overall reducing the costs of treating MRSA infections,” commented Dr. Peter Klemm, President and CEO of GeneOhm Sciences.
About GeneOhm Sciences, Inc.
GeneOhm Sciences is a molecular diagnostic company with locations in San Diego, CA and Quebec City, Quebec, Canada. Its current commercial product portfolio includes two rapid, amplified nucleic acid-based assays cleared by the FDA, Health Canada and bearing the CE mark: the IDI-Strep B™ Assay for rapid detection of Group B Streptococcus and the IDI-MRSA™ Assay for rapid detection of methicillin-resistant Staphylococcus aureus directly from clinical specimens. These products are the first molecular-based diagnostic products cleared by the FDA which meet the specifications required to replace standard culture methods. Future products include assays to detect vancomycin resistance and combined MRSA/methicillin-sensitive Staphylococcus aureus. GeneOhm’s future product pipeline is based on the company’s broad portfolio of molecular-based technology for processing and detecting nucleic acids from a variety of specimens. These diagnostic products will serve unmet needs in a wide range of diseases, including infectious diseases, inherited diseases and oncology.
Threshold Pharmaceuticals Announces Management Update; Founder Resigns from President Role, Retains Board and Advisory Roles
Redwood City, CA – August 19, 2005
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD), today announced that George F. Tidmarsh resigned as president, effective immediately. Dr. Tidmarsh will remain on the Board of Directors and serve as chairman of the Clinical Advisory Board. He is founding a new entrepreneurial startup venture.
"George is a remarkable individual whose energy, passion, and vision formed the basis of what is today a very strong company with a rich clinical portfolio and deep discovery research capabilities," said Barry Selick, chief executive officer. "He will continue to provide important input and work closely with us in his continuing strategic roles. We wish him the best of luck as he pursues new business interests."
"I'm proud of what we've accomplished at Threshold and feel the company is extremely well positioned for the future," said Dr. Tidmarsh. "With two late stage drug candidates in Phase 3 trials and promising clinical data, Threshold has a world class organization to manage these products through to commercialization successfully."
Threshold Pharmaceuticals Announces Initiation of Phase 3 Trial in Europe for the Treatment of Benign Prostatic Hyperplasia
Redwood City, CA – August 8, 2005
Threshold Pharmaceuticals Inc. (NASDAQ: THLD) today announced the initiation of a Phase 3 clinical trial as part of a registrational program of its investigational drug candidate TH-070 (lonidamine). The study will measure the dosing, safety, and efficacy of TH-070 in subjects with symptomatic benign prostatic hyperplasia (BPH). The company has begun patient enrollment and will conduct the trials at nearly 60 investigational sites in selected European countries. The Phase 3 trial will be a randomized, placebo-controlled, double-blinded study, enrolling men 50-80 years of age with symptomatic BPH. Approximately 480 patients will participate in the study for up to four and a half months. The primary objective is to evaluate the efficacy of TH-070 (50 mg, 150 mg) compared to placebo as measured by I-PSS (International Prostate Symptom Scores) in subjects with symptomatic BPH.
“We are excited about the potential of this therapy based on promising Phase 2 clinical data,” said Alan Colowick, chief medical officer of Threshold. “This is another important clinical milestone in our registrational program. The Phase 3 European trial complements our Phase 2 trial recently begun in the United States.”
The study is also designed to confirm the findings for 28 days of dosing previously announced by Threshold from a Phase 2 single center study conducted in 2004 at the University of Bari, Italy. That trial met its primary endpoint, a mean reduction in prostate volume measured by trans-rectal ultrasound (TRUS) at day 28 compared to baseline (-11.2%, p<0.001), and all other day 28 endpoints. Six months after cessation of treatment, BPH symptoms (International Prostate Symptom Scores) in patients remained significantly improved compared to baseline as were maximum urine flow, post-void urine volume, and PSA (Prostate Specific Antigen).
Detailed results of the study were published by MedReviews in the quarterly journal of Reviews in Urology. The information is available online at the MedReviews website http://www.medreviews.com.
About TH-070 and prostate metabolism
TH-070, an indazole-3-carboxylic acid, is thought to disrupt energy metabolism by interfering with glycolysis. Glandular prostate epithelial cells – cells that overgrow in BPH – are unique in that they are dependent on glycolysis for energy production. Preclinical data and Phase 2 data thus far support that TH-070 presents a potentially effective method for targeting these prostate cells and may provide rapid symptom improvement, decreased prostate size, increase in urine flow, decreased serum PSA, and limited side effects for the treatment of BPH.
About Benign Prostatic Hyperplasia (BPH)
BPH, also known as benign enlargement of the prostate, is the most common urological problem among older men and affects an estimated 18 million men in the United States, 28 million men in five major European countries and eight million men in Japan. BPH can restrict the flow of urine, resulting in urine retention, which can cause weakening of the bladder wall and the inability to empty the bladder completely. It can also be progressively severe, with a risk of urinary tract infection, kidney and bladder damage, bladder stones and incontinence. However, current drug and surgical therapies for BPH are not completely effective, often having slow onset and with side effects ranging from decreased libido, sexual dysfunction and reduced quality of life to cardiovascular effects and/or surgical complications.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics. By selectively targeting tumor and certain other diseased cells, the company is building a pipeline of drug candidates that hold promise to be more effective and less toxic to healthy tissues than conventional drugs. Threshold's initial clinical focus is the treatment of cancer and benign prostatic hyperplasia, or BPH, a disease afflicting tens of millions of men worldwide.
Cellular Genomics Selects Drug Development Candidate in Proprietary Angiogenesis Inhibitor Program; Changes Corporate Name to CGI Pharmaceuticals
Branford, CT – (PRNewswire) – July 13, 2005
Cellular Genomics, Inc. (CGI), a drug discovery and development company focused on the development of novel kinase inhibitors for the treatment of cancer and autoimmune and inflammatory diseases, today announced that it has selected cgi1842, a novel multi-targeted kinase inhibitor, as a preclinical development candidate in its angiogenesis/oncology program. A proprietary compound designed and synthesized at CGI, cgi1842 is being developed as an oral therapy for the treatment of cancer. Concurrent with the achievement of this milestone, the Company announced that is has changed its corporate name to CGI Pharmaceuticals, Inc. The name change is reflective of the Company's successful progression to a drug development company.
"Our new name and the achievement of this seminal milestone in our angiogenesis inhibitor program underscore our successful evolution to an integrated drug discovery and development company," said Louis Matis, M.D., President and CEO of CGI Pharmaceuticals. "The rapid progress we have made in our kinase inhibitor therapeutic programs reflects the productivity of our unique integrated approach to kinase drug discovery and development, and marks an exciting new phase of growth for CGI Pharmaceuticals."
cgi1842 is representative of a highly novel class of orally available multi-targeted small molecule kinase inhibitor therapeutics discovered and developed at CGI Pharmaceuticals for angiogenesis inhibition in the treatment of cancer and other diseases. cgi1842 displays a unique specificity profile, distinct from any target profiles described for other drugs in development, selectively inhibiting a spectrum of kinases responsible for all major stages of tumor angiogenesis. In preclinical studies, cgi1842 has demonstrated robust anti-tumor activity in multiple human tumor types, as well as excellent in vivo oral pharmacokinetic properties and safety profiles. CGI Pharmaceuticals is advancing this compound toward IND submission in the second quarter of 2006.
The demonstrated clinical efficacy of kinase pathway inhibition targeting the tumor blood supply indicates that this approach has broad potential for treating multiple human cancers and represents a large commercial opportunity. Moreover, as angiogenesis is a complex, multi-step process that requires activation of a number of key kinase pathways, there is growing preclinical and clinical evidence that targeting multiple kinase pathways will be critical for achieving optimal clinical inhibition of tumor angiogenesis and, thus, inhibition of tumor growth and disease progression
Threshold Pharmaceuticals Initiates Registrational Program of TH-070 for Treatment of Benign Prostatic Hyperplasia; U.S. Phase 2 Clinical Trials Underway
Redwood City, CA – June 27, 2005
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) announced today the initiation of its registrational program of its investigational drug candidate, TH-070 (lonidamine), under a U.S. Food and Drug Administration IND. The company has begun a U.S. Phase 2 clinical trial evaluating the dosing, safety and activity of TH-070 for the treatment of symptomatic benign prostatic hyperplasia (BPH). A Phase 3 multi-center European trial evaluating the safety and efficacy of TH-070 is expected to commence in mid 2005. BPH is a non-cancerous enlargement of the prostate that affects over 54 million men worldwide and at least 17 million men over the age of 40 in the United States.
The Phase 2 trial is a randomized, placebo controlled, double-blinded study that will be conducted at up to thirty centers across the United States. Approximately 200 patients will participate in the study for up to four and a half months. Patients will be randomized to receive placebo or one of four doses of TH-070 daily for 28 days, and will be followed off of therapy for an additional three months. The primary objective of this study is to investigate the dose-response relationship of TH-070 with respect to efficacy and safety.
Additionally, this study is designed to confirm the findings for 28 days of dosing previously announced by Threshold from a Phase 2 single center study conducted in 2004 at the University of Bari, Italy. That trial met its primary endpoint, a mean reduction in prostate volume measured by Trans-rectal Ultrasound (TRUS) at day 28 compared to baseline (-11.2%, p<0.001), and all other day 28 endpoints. Six months after cessation of treatment, BPH symptoms (International Prostate Symptom Scores) in patients remained significantly improved compared to baseline as were maximum urine flow, post-void urine volume, and PSA (Prostate Specific Antigen).
Detailed results of the study were published by MedReviews in the quarterly journal of Reviews in Urology. The information is available online at the MedReviews website http://www.medreviews.com.
“Our U.S. trial demonstrates Threshold's ability to launch a major clinical program in the BPH setting,” said Alan Colowick, chief medical officer of Threshold. “We are excited about the potential that this therapy may offer men suffering from the symptoms of BPH while addressing the underlying disease itself. This trial complements a Phase 3 trial that will soon be initiated in Europe.”
Both studies will investigate the effects of TH-070 on clinically important efficacy endpoints, including impact on symptoms as measured by IPSS, prostate volume measured by TRUS, change in PSA, change in maximal flow rate of urine, and a change in post-void residual of urine.
“The data thus far suggests that there is great promise for this treatment,” said Dr. Claus Roehrborn, Chair of Urology at University of Texas, Southwestern and one of the lead investigators in the U.S. Phase 2 trial. “TH-070 has the potential to actually reverse the BPH process and bring relief to many men who suffer from this condition.”
About TH-070 and prostate metabolism
TH-070 is thought to disrupt energy metabolism by interfering with glycolysis. Glandular prostate epithelial cells – cells that overgrow in BPH – are unique in that they are dependent on glycolysis for energy production. Preclinical data and Phase 2 data thus far supports that TH-070 presents a potentially effective method for targeting these prostate cells and may provide rapid symptom improvement, decreased prostate size, increase in urine flow, decreased serum PSA, with limited side effects for the treatment of BPH.
About Benign Prostatic Hyperplasia (BPH)
BPH, also known as benign enlargement of the prostate, is the most common urological problem among older men and affects an estimated 17 million men in the United States, 27 million men in five major European countries and 8 million men in Japan. BPH can restrict the flow of urine, resulting in urine retention, which can cause weakening of the bladder wall and the inability to empty the bladder completely. It can also be progressively severe, with the risk of urinary tract infection, kidney and bladder damage, bladder stones and incontinence. Current drug and surgical therapies for BPH are not very effective, often having slow onset and with side effects ranging from decreased libido, sexual dysfunction and reduced quality of life to cardiovascular effects and/or surgical complications.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics based on Metabolic Targeting, an approach that offers broad potential to treat most solid tumors and certain other diseases. The company is building a pipeline of drug candidates that selectively target tumor cells, offering the potential to be more effective and less toxic to healthy tissues than conventional drugs. Threshold's initial clinical focus is the treatment of cancer and benign prostatic hyperplasia, or BPH, a disease afflicting tens of millions of men worldwide.
GeneOhm Sciences Additional Series C Funding from Wasatch Advisors; Series C Adds Additional World Class Healthcare Investor
San Diego, CA – May 24, 2005
GeneOhm Sciences, an emerging leader in molecular diagnostics, announced that the company closed follow-on Series C funding with Wasatch Advisors.
Wasatch Advisors, investment adviser to institutional clients and a family of mutual funds, specializes in small cap growth investing. Wasatch focuses on small cap companies with business models that enable sustained growth and margins and makes a select few private company investments with an eye toward further investment potential after the company completes an initial public offering.
"We believe that GeneOhm's portfolio of current products, content and technology, combined with the experience they have in developing and commercializing new products will continue to change the way medicine can be practiced," said Karey Barker, Principal and Portfolio Manager, of Wasatch Advisors.
"We are thrilled to welcome Wasatch as an investor in GeneOhm Sciences. To have our first institutional money manager is a significant statement in support of our mission to transform health-care by enabling earlier and more definitive clinical decisions," commented Dr. Peter Klemm, President and CEO of GeneOhm Sciences.
About GeneOhm Sciences, Inc.
GeneOhm Sciences is a molecular diagnostic company with locations in San Diego, CA and Quebec City, Quebec, Canada. Its current commercial product portfolio includes two rapid, amplified nucleic acid-based assays cleared by the FDA, Health Canada and bearing the CE mark: the IDI-Strep B(TM) Assay for rapid detection of Group B Streptococcus and the IDI-MRSA(TM) Assay for detection of methicillin-resistant Staphylococcus aureus directly from clinical specimens. These products are the first molecular-based diagnostic products cleared by the FDA which meet the specifications required to replace standard culture methods. Future products include assays to detect vancomycin resistance and methicillin-sensitive Staphylococcus aureus. GeneOhm's rich product pipeline is based on the company's broad portfolio of molecular-based technology for processing and detecting nucleic acids from a variety of specimens. These diagnostic products will serve unmet needs in a wide range of diseases, including infectious diseases, inherited diseases and oncology.
Threshold Pharmaceuticals Announces Positive Results from TH-070 Phase 2 Study in Treatment of Benign Prostatic Hyperplasia; Trial Shows Significant Sustained Improvement in Symptoms Six Months Off Therapy
Redwood City, CA – May 19, 2005
Threshold Pharmaceuticals Inc. today announced follow up results of a Phase 2 study of its investigational drug candidate, TH-070 (lonidamine) for the treatment of benign prostatic hyperplasia (BPH). Six months after cessation of treatment, BPH symptoms (IPSS) in patients remained significantly improved compared to baseline as were maximum urine flow, post void urine volume, and PSA.
The trial, conducted in 2004 at the University of Bari, Italy, met its primary endpoint, a mean reduction in prostate volume at day 28 compared to baseline (-11.2%, p<0.001), and all other Day 28 endpoints. Based on promising data from the initial dose group of patients in this study, Threshold elected not to enroll a second higher dose group and instead plans to initiate a Phase 2 multi-center study in the US and a Phase 3 multi-center study in Europe for TH-070 to treat symptomatic BPH in mid 2005.
In the reported trial, thirty patients with symptomatic BPH received TH-070 orally (150 mg) once daily for 28 days. The regimen was well tolerated, with no therapy-related adverse side effects. Highlights of the post study follow-up results six months later include: • Validated International Prostate Symptom Scores (IPSS) improved from a mean of 19.5 prior to treatment to 12.2 at Day 28 (p<0.001) with an additional improvement to 9.8 after six month follow-up.
• Mean Maximum Urine Flow improved 34.3% from a mean of 9.4 mL/sec at baseline to 12.6 mL/sec at day 28 (p=0.002) and improved 45.6% to a mean of 13.7 mL/sec at six month follow-up (p<0.001).
• PSA decreased on average by 17.8 percent from a mean of 3.6 at baseline to 2.8 ng/mL at Day 28 (p<0.001) and on average by 14.8% to a mean of 3.1 ng/mL at six month follow-up (p=0.012).
• Mean PVR (Post-void residual urine volume) decreased by 52.5 percent from a mean of 82.1 cc at baseline to 31.6 cc at Day 28 (p<0.001) and to 39.0 cc at six month follow-up (p=.003).
“The magnitude and rapidity of the patients' response to TH-070 are very encouraging in the pharmaceutical treatment of BPH,” said George Tidmarsh, founder of Threshold Pharmaceuticals. “We are especially pleased to see that the effect of TH-070 is sustained off therapy.”
Detailed results of the study will be published by MedReviews in the quarterly journal of Reviews in Urology available at the American Urology Association (AUA) annual meeting in San Antonio, Texas May 22 – 25, 2005. The information will be also be available May 18th online at the MedReviews website http://www.medreviews.com.
About the Phase 2 Study
Subjects were assessed at baseline, at active-therapy assessment visits (days 14, 28), and 1, 2, 3, and 6 months post-therapy. Assessments included prostate volume (PV) by transrectal ultrasound (TRUS), maximum flow rate (Qmax) on uroflowmetry, post-void residual urine volume (PVR), International Prostate Symptom Score (IPSS), prostate specific antigen (PSA) levels, serum chemistry, and adverse events. Previous treatment with 5-alpha-reductase inhibitors was not allowed and alpha-blockers were discontinued at least 14 days prior to study.
About TH-070 and prostate metabolism
TH-070, an indazole-3-carboxylic acid, is thought to disrupt energy metabolism by interfering with glycolysis. Glandular prostate epithelial cells – cells that overgrow in BPH – are unique in that they are dependent on glycolysis for energy production. Preclinical data and Phase 2 data thus far supports that TH-070 presents a potentially effective method for targeting these prostate cells and may provide rapid symptom improvement, decreased prostate size, increase in urine flow, decreased serum PSA, and limited side effects for the treatment of BPH.
About Benign Prostatic Hyperplasia (BPH)
BPH, also known as benign enlargement of the prostate, is the most common urological problem among older men and affects an estimated 17 million men in the United States, 27 million men in five major European countries and eight million men in Japan. BPH can restrict the flow of urine, resulting in urine retention, which can cause weakening of the bladder wall and the inability to empty the bladder completely. It can also be progressively severe, with a risk of urinary tract infection, kidney and bladder damage, bladder stones and incontinence. However, current drug and surgical therapies for BPH are not completely effective, often having slow onset and with side effects ranging from decreased libido, sexual dysfunction and reduced quality of life to cardiovascular effects and/or surgical complications.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics based on Metabolic Targeting, an approach that offers broad potential to treat most solid tumors and certain other diseases. By selectively targeting tumor cells, the company is building a pipeline of drug candidates that hold promise to be more effective and less toxic to healthy tissues than conventional drugs. Threshold's initial clinical focus is the treatment of cancer and benign prostatic hyperplasia, or BPH, a disease afflicting tens of millions of men worldwide. For additional information, please visit http://www.thresholdpharm.com.
Bionaut Pharmaceuticals Announces Research Collaboration with the National Cancer Institute; Collaboration to Profile Lead Compounds and Discover Biomarkers for Cancer
Cambridge, MA – May 19, 2005
Bionaut Pharmaceuticals, Inc. announced today a research collaboration with the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) to profile Bionaut cancer compounds that inhibit the ability of tumor cells to survive various stress conditions. NCI and Bionaut will also collaborate to identify new biomarkers in tumor cells that are affected by Bionaut's lead cancer compounds.
Bionaut will provide to the collaboration its lead compounds which have been shown to modulate stress response in tumors. NCI will test Bionaut's compounds against a panel of tumor cell lines and measure biomarkers that are induced or suppressed. NCI will also evaluate Bionaut's compounds for their therapeutic potential to alter metastasis by testing for suppression of invasion/migration in vitro with several highly metastatic cell lines. Increased metastasis of tumor cells is often associated with the ability of these cells to survive stress.
“This collaboration is unique as it brings Bionaut's expertise in a novel pathway, our lead compounds and our Sentinel® Pathway Reporter System together with NCI's own expertise and NCI's panel of tumor cell lines for testing and identifying new anti-cancer drugs and biomarkers,” said Thomas Klein, Chief Operating Officer. “This collaboration is also highly relevant to the FDA's initiatives to identify biomarkers associated with cancer to monitor experimental treatments and predict clinical outcome.”
Bionaut's Cancer Program
Cellular signaling pathways regulate proliferation, angiogenesis and cell death. Cancer cells have adapted these pathways to allow tumors to survive and grow under stress conditions. In addition, exposure to most chemotherapeutic agents further induces stress. Responding to this stress, some cancer cells survive chemotherapy by secreting growth factors which are responsible for proliferation and angiogenesis by blocking cell death and initiating drug resistance.
Bionaut has applied its Sentinel® Pathway Reporter System to selectively measure the activity of cellular signaling pathways in cancer cells. Bionaut has identified BNC4, as well as other compounds in this class, which specifically inhibit the ability of cancer cells to grow under stress conditions in a variety of in vitro studies. Excellent in vivo activity has been demonstrated in human renal, pancreatic and non-small cell lung cancer xenograft models.
Bionaut Pharmaceuticals
Bionaut's business strategy is to discover novel small molecule drug candidates that affect well-validated disease pathways and to advance such discoveries through late stage pre-clinical status for further development in partnership with pharmaceutical and large biotechnology companies. Bionaut employs its patented Sentinel® Pathway Reporter System to initiate the discovery process. Bionaut's Sentinel® system can greatly increase the chances of a positive clinical outcome for a new drug candidate by correlating pathway-specific interference directly with disease modulation in living human cells. Bionaut has applied the highly predictive capabilities of its Sentinel® system to build a pipeline of its own drug candidates in the areas of cancer and inflammation and continues to expand its efforts into other therapeutic areas. In addition, Bionaut will assist strategic partners with drug discovery and lead optimization in disease areas of their choice. More information about Bionaut can be found on the Company's website at www.bionautpharma.com.
Multiple Studies Presented at the American Society of Clinical Oncology Meeting Show Consistent Positive Results for the Onco type DX™ Breast Cancer Assay; Data Presentations Reinforce Recurrence Score's Ability to Predict Chemotherapy Benefit; Capture Prognosis and Response to Tamoxifen; ASCO Selects National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health Chemotherapy Response Study for “Best of Oncology” Special Session
Orlando, FL – May 17, 2005
Genomic Health, Inc. announced that results from three independent studies evaluating the Oncotype DX breast cancer assay were presented at the 41st annual meeting of the American Society of Clinical Oncology (ASCO). These studies examined the assay's ability to quantify likelihood of recurrence, predict response to chemotherapy, and capture both prognosis and response to tamoxifen in a large portion of early stage breast cancer patients. Initial findings from these studies were presented at the 27th Annual San Antonio Breast Cancer Symposium (SABCS) in December 2004.
“The fact that these studies continue to gain attention among the oncology community is a significant indication of the impact Oncotype DX is having in clinical practice,” said Steven Shak, M.D., chief medical officer, Genomic Health. “Genomic Health and its collaborators, including NSABP and Kaiser Permanente, are leading the field of individualized medicine by bringing Oncotype DX into oncology practice today.”
ASCO's “Best of Oncology” Features NSABP's B-20 Chemotherapy Response Study
The NSABP/Genomic Health study “Expression of the 21 genes in the Recurrence Score assay and prediction of clinical benefit from tamoxifen in NSABP study B-14 and chemotherapy in NSABP study B-20” was selected from numerous studies by the ASCO Cancer Education Committee to be featured in a special session called “Best of Oncology.” The study -- which demonstrated the same Oncotype DX 21-gene panel that quantifies the likelihood of breast cancer recurrence also predicts chemotherapy benefit -- will be presented by Soonmyung Paik, M.D., director of the NSABP Division of Pathology, on Tuesday, May 17, 2005, 12:00-12:10pm (EDT) during a session where ASCO highlights critical scientific advances in oncology that have been presented at other oncology-related meetings in the last year. The NSABP/Genomic Health Study is the only study from the 2004 San Antonio Breast Cancer Symposium to be selected as “Best of Oncology.”
The NSABP B-20 chemotherapy benefit study of 651 patients demonstrated that breast cancer patients with high Recurrence Scores (and high risk of recurrence), as identified by the Oncotype DX assay, also have a large absolute benefit from chemotherapy. This group represents about 25 percent of patients with node-negative, estrogen receptor-positive breast cancer. Patients with low Recurrence Scores (and low risk of recurrence) only derive minimal, if any, benefit from chemotherapy and represent about 50 percent of patients with node-negative, estrogen receptor-positive breast cancer.
“These findings are changing the way breast cancer treatment decisions are made today,” said Norman Wolmark, M.D., chair of the National Surgical Adjuvant Breast and Bowel Project (NSABP), and the Department of Human Oncology at Allegheny General Hospital in Pittsburgh, Pennsylvania. “We now have a tool that allows physicians and patients to feel confident about their choice of therapy based on a Recurrence Score that reflects their individual disease.”
NSABP B-14 Tamoxifen Benefit Study
On Sunday, May 15, Genomic Health and NSABP presented results from a study (Abstract #510) that evaluated tumor tissues from 645 patients in the NSABP B-14 trial, who were treated either with placebo or with tamoxifen, to determine whether the Oncotype DX Recurrence Score assay reflects pure prognosis, responsiveness to hormonal therapy, or both. Results of the study presented in an oral discussion showed that the assay predicts the likelihood of recurrence in node-negative, estrogen receptor-positive breast cancer because it captures both prognosis and the response to hormonal treatment.
“In combining both prognostic and predictive factors for patients with node-negative estrogen receptor-positive breast cancer, Oncotype DX can help us determine which patients will benefit from hormonal treatment,” said Soonmyung Paik, M.D., director of the NSABP Division of Pathology. “These findings reinforce the important insight we gain from the Recurrence Score and its significant contribution to the individualized treatment of patients diagnosed with breast cancer.”
Northern California Kaiser Permanente Study
Northern California Kaiser Permanente presented findings on Monday, May 16, from a community-based study from 14 Northern California hospitals (Abstract #603, Poster # C12). These results of the study of 790 cases and controls showed a strong and graded association between the Oncotype DX Recurrence Score and 10-year breast cancer-specific mortality (p<0.001). The assay provided information that goes beyond that provided by tumor size and tumor grade. The Oncotype DX assay identifies a large proportion of these women who have a low risk (less than 3 percent) of breast cancer death at 10 years. These results in a community-based patient population representing approximately one percent of the U.S. population were similar to those from the large trials conducted previously by the NSABP, including the one published in The New England Journal of Medicine in December 2004.
This study also looked at node negative patients with ER positive or ER negative tumors who were not treated with tamoxifen and found that the Oncotype DX assay and the Quantitative Proliferation Index - a subset of genes from the assay - predicted risk of recurrence in this patient population. The results from this part of the study closely paralleled those from the B-14 Tamoxifen Benefit study noted above.
American Journal of Managed Care Publishes Economic Analysis
On Friday, May 13, the American Journal of Managed Care published a comprehensive economic analysis that demonstrated Oncotype DX, when used appropriately, can reduce treatment costs and simultaneously improve net medical outcomes, including survival, when adjusted for the negative impact on quality of life associated with chemotherapy treatment.
About Oncotype DX
Introduced in 2004, the Oncotype DX breast cancer assay represents the first diagnostic gene expression test on the market that provides consistent results across multiple independent trials. The assay has been extensively evaluated in numerous independent studies involving more than 2,600 breast cancer patients, including a large validation study published in the December 30, 2004 edition of The New England Journal of Medicine. For more information about Oncotype DX, please visit www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. is an oncology-based biotechnology company that provides clinically validated genomic tests to improve the quality of treatment decisions for patients with cancer. The company employs a sophisticated, quantitative approach to molecular pathology (the Oncotype DX platform) to provide to cancer patients and their physicians individualized genomic information on the likelihood of disease recurrence and response to therapy. The company was founded in August 2000 and provides commercial Oncotype DX services through its CLIA and CAP certified clinical reference laboratory located at its headquarters in Redwood City, California.
Genomic Health, Inc. Announces Publication of Comprehensive Economic Analysis Confirming Cost-Effectiveness of Onco type DX™ in the American Journal of Managed Care ; Findings Reinforce Value of Recurrence Score Testing and Provide Support for Favorable Reimbursement Coverage Policies
Redwood City, CA – May 13, 2005
Genomic Health, Inc. today announced that The American Journal of Managed Care published the results of a comprehensive economic analysis demonstrating that the breast cancer assay, Oncotype DX, which measures gene expression for a 21-gene panel from individual tumor specimens, may improve survival for some patients and can reduce treatment costs when used appropriately with women who have node-negative, estrogen receptor-positive breast cancer. The analysis, “Economic Analysis of Targeting Chemotherapy Using a 21-Gene RT-PCR Assay in Lymph-Node-Negative, Estrogen-Receptor-Positive, Early-Stage Breast Cancer,” is based on earlier clinical research findings that show the “Recurrence Score” generated by Oncotype DX more accurately quantifies the likelihood of breast cancer recurrence compared to classification by existing guidelines, and helps predict chemotherapy benefit for these women.
“Even with conservative assumptions in place, the Oncotype DX breast cancer assay can provide economic returns that substantially offset the cost of the test and in some settings may generate net cost savings to health plans while improving overall medical outcomes for patients,” said John Hornberger, M.D., M.S., senior research associate, The SPHERE Institute / Acumen, LLC, staff physician of the Department of Veterans Affairs, adjunct clinical professor of medicine, Stanford University, and lead author of the study. “It is rare for a newly introduced technology to demonstrate the ability to improve outcomes for a defined segment of patients and simultaneously increase the economic efficiency of health care delivery in a rigorous analytic model.”
The analysis published in AJMC projects the benefits, costs, and cost effectiveness of the Oncotype DX assay based on empirical evidence of its clinical effectiveness. The goal was to evaluate whether adoption of the Oncotype DX test could provide net economic benefits to the health care system. The researchers found that the estimated cost effectiveness of the Oncotype DX assay, when appropriately used to quantify the individual risk for patients with node-negative, estrogen receptor-positive early stage breast cancer, is well within the established range of other generally accepted healthcare technologies funded in the United States.
The analysis evaluated 10-year distant recurrence-free survival and overall survival in patients with lymph node negative, estrogen receptor positive early stage breast cancer, as well as relevant costs associated with the use of the Recurrence Score to reclassify risk of recurrence as compared with risk classification using current National Comprehensive Cancer Network guidelines. Outcomes were evaluated using a common framework for health economic appraisals, the Markov model, which provides a well accepted method of modeling prognosis.
In the absence of reliable methods for assessing recurrence risk on an individual basis, the majority of women with breast cancer have been treated with chemotherapy even though only a small subset may benefit. Oncotype DX provides important information for predicting the likelihood of benefit from chemotherapy in estrogen receptor-positive, lymph node-negative patients. This information is valuable in determining if a patient can safely avoid the cytotoxic effects and high costs of chemotherapy.
Introduced in 2004, the Oncotype DX breast cancer assay represents the first diagnostic gene expression test on the market that provides consistent results across multiple independent trials. The assay has been extensively evaluated in numerous independent studies involving more than 2,600 breast cancer patients, including a large validation study published in the December 30, 2004 edition of The New England Journal of Medicine.
The American Journal of Managed Care is an independent, peer-reviewed publication dedicated to publishing original research in healthcare outcomes and creating a forum for scientific communication in the ever-evolving field of healthcare delivery. The journal is indexed in MEDLINE/PUBMED.
About Genomic Health
Genomic Health, Inc. is an oncology-based biotechnology company that provides clinically validated genomic tests to improve the quality of treatment decisions for patients with cancer. The company employs a sophisticated, quantitative approach to molecular pathology (the Oncotype DX platform) to provide to cancer patients and their physicians individualized genomic information on the likelihood of disease recurrence and response to therapy. The company was founded in August 2000 and provides commercial Oncotype DX services through its CLIA and CAP certified clinical reference laboratory located at its headquarters in Redwood City, California.
Threshold Pharmaceuticals To Sponsor 2nd International Tumor Metabolism Summit in Genova Italy October 7-8, 2005; Event To Feature Presentations from Some of the World's Leading Experts in Cancer Research
Redwood City, CA – May 11, 2005
Threshold Pharmaceuticals Inc. today announced that it will sponsor the 2nd International Tumor Metabolism Summit (TMS 2005) at the Palazzo Ducale in Genova, Italy October 7-8, 2005. This year's theme is "Exploiting the Tumor Microenvironment for Therapeutics."
TMS 2005 will feature several of the world's leading experts in this emerging field. Invited speakers will present on their most recent findings in this important aspect of tumor biology. These presentations include new insights into the molecular mechanisms controlling tumor cell metabolism, the role of HIF-1 in response to hypoxia, selective markers for hypoxia and novel therapeutic approaches to treat cancer based on the tumor microenvironment.
Program organizers for TMS 2005 are:
• Gregg L. Semenza, MD, PhD
Director, Vascular Program; Professor, Pediatrics, Medicine, Oncology, Radiation Oncology - Johns Hopkins University School of Medicine
"Novel Regulators and Targets of HIF-1"
• Giovanni Melillo, MD
Senior Investigator - National Cancer Institute at Frederick
"Targeting the Tumor Microenvironment: Small Molecule Inhibitors of Hypoxia Inducible Factor 1 (HIF-1)"
Invited speakers and presentation topics include:
• Paolo M. Comoglio, MD, PhD
Full Professor of Histology, University of Turin School of Medicine and Scientific Director, Institute for Cancer Research and Treatment
"Invasive Growth: A Genetic Program Linking Cancer to Hemostasis"
• Chi V. Dang, MD, PhD
Professor in Oncology Research; Vice Dean for Research - Johns Hopkins University School of Medicine
"Novel Insights on Molecular Mechanisms Underlying the Warburg Effect: Myc, Akt and HIF-1"
• Amato J. Giaccia, PhD
Professor, Radiation Oncology; Director, Division of Cancer and Radiation Biology - Stanford University School of Medicine
"Tumor Targeted Therapy Exploiting the HIF/VHL Pathway"
• Adrian L. Harris, MD, PhD
Professor - Cancer Research UK, Oxford Cancer Centre
"Role of Carbonic Anhydrase 9 in Cancer Cell Hypoxia Response"
• Randall S. Johnson, PhD
Guest Professor - Karolinska Institute
"Hypoxia and Vascularization: Angiogenesis Requires a HIF-1 Response"
• Eric J. Stanbridge, PhD
Distinguished Professor - University of California Irvine
"The Tumor and Hypoxia Biomarker Carbonic Anhydrase IX: Diagnostic, Prognostic and Therapeutic Applications"
• Luigi Varesio, PhD
Chief, Laboratory of Molecular Biology - Giannina Gaslini Institute
"Response of Macrophages to Hypoxia and Picolinic Acid"
TMS 2005 will focus on the integration of recent advances in the understanding of molecular, cellular and tissue responses to the tumor microenvironment. In particular, the conference is designed to facilitate dialogue toward the design of novel, targeted therapeutic strategies for the treatment of cancer.
In addition, the conference will offer presentations of selected abstracts. Abstract submissions will be reviewed by the conference organizers (Dr. Semenza and Dr. Melillo) for relevance to the TMS 2005 theme, scientific importance, and rigor. Selected work will be designated for a brief oral presentation or for poster presentation.
For more information on the conference, to register, or submit an abstract go to www.tmsabstracts.com.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics based on Metabolic Targeting, an approach that offers broad potential to treat most solid tumors and certain other diseases. By selectively targeting tumor cells, the company is building a pipeline of drug candidates that hold promise to be more effective and less toxic to healthy tissues than conventional drugs. Threshold's initial clinical focus is the treatment of cancer and benign prostatic hyperplasia, or BPH, a disease afflicting tens of millions of men worldwide. For additional information, please visit http://www.thresholdpharm.com.
Threshold Pharmaceuticals Announces First Quarter 2005 Results
Redwood City, CA - May 2, 2005
Threshold Pharmaceuticals, Inc. (Nasdaq: THLD) today announced its 2005 first quarter earnings. The net loss for the quarter was $7.5 million compared to $2.8 million for the same period last year. The increase in the net loss reflects the growth of the company as well as the advancement of Glufosfamide into a Phase 3 trial for second-line pancreatic cancer and into a Phase 1/2 trial for first-line treatment of pancreatic cancer in combination with gemcitabine. Included in the net loss are non-cash stock compensation expenses of $1.6 million and $0.3 million for the first quarter of 2005 and 2004 respectively.
"Our first quarter was very exciting for everyone at Threshold," said Barry Selick, Threshold's chief executive officer. "We completed our Initial Public Offering, raising net proceeds of approximately $38 million. We also continued the clinical trials of all of our key cancer product candidates and, based on the results of our first Phase 2 clinical trial of TH-070, our BPH product candidate, we are looking forward to beginning planned trials in both the US and Europe. In the first quarter of 2005, we were also pleased to have Dr. Alan Colowick, formerly Vice President of European Medical Affairs at Amgen, join us as our chief medical officer," concluded Dr. Selick.
At March 31, 2005, Threshold had $61.1 million in cash and marketable securities.
Operating Expense Analysis:
• Research and development expenses totaled $5.3 million for the first quarter of 2005 versus $2.0 million for the first quarter of the prior year. This increase was primarily due to additional clinical trial and development expenses for the product candidates Glufosfamide, TH-070 and 2DG, expenses associated with increased staffing and non-cash stock compensation expenses.
• General and administrative expenses were $2.6 million for the first quarter of 2005 versus $0.9 million for the same quarter of the prior year. This increase was primarily due to increased staffing and headcount related expenses, and non-cash stock compensation expenses.
First Quarter 2005 Product Candidate Highlights
Threshold's clinical programs are focused on cancer and Benign Prostatic Hyperplasia (BPH), a disease characterized by an overgrowth of the prostate. BPH results in a variety of lower urinary tract symptoms such as frequent and sometimes difficult urination. With the BPH program, the company expects to:
• initiate a Phase 2 study of TH-070 in patients with BPH in the United States by mid-2005
• initiate a Phase 3 study of TH-070 in patients with BPH in Europe by mid-2005
In the cancer program, the company has three clinical trials ongoing, the most advanced of which is a Phase 3 pivotal study of Glufosfamide for the treatment of patients with second-line pancreatic cancer. This two-arm trial will compare survival of patients who have received Glufosfamide to those who have received best supportive care, since there is no currently approved second-line treatment for pancreatic cancer. The company has received a Special Protocol Assessment and Fast Track designation from the FDA for this trial. The company is also evaluating Glufosfamide in a Phase 1/2 study in combination with gemcitabine for the first-line treatment of advanced pancreatic cancer patients and other solid tumors. The trial will evaluate various doses of Glufosfamide in combination with the standard dose of gemcitabine. Finally, the company has a Phase 1 study ongoing with 2-Deoxyglucose (2DG) alone and in combination with Taxotere for the treatment of various solid tumors. This study is designed to evaluate the safety, blood levels and maximum tolerated dose in patients with solid tumors. All studies continue to enroll patients.
The company anticipates the following clinical milestones in its cancer program:
• data from 12 patients available from the 2DG Phase 1 study in solid tumors in Q2 2005, and additional patient data in Q4 2005
• data available for the Glufosfamide Phase 1 study in combination with gemcitabine in Q4 2005
• complete enrollment of the Phase 3 Glufosfamide study in second-line pancreatic cancer patients in Q1 2006
2005 Financial Guidance
The company expects 2005 cash requirements to be in the range of $32 to $38 million, potentially offset by proceeds from licensing or development agreements, if any. The company expects the net loss for 2005, including non-cash compensation expenses to be in the range of $36 to $44 million.
To access the live audio broadcast or the subsequent archived recording please log on to the Investor section of the Threshold Pharmaceuticals website: http://www.thresholdpharm.com.
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For more information on Threshold Pharmaceuticals, please refer to the Threshold website at http://www.thresholdpharm.com.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics based on Metabolic Targeting, an approach that offers broad potential to treat most solid tumors and certain other diseases. By selectively targeting tumor cells, the company is building a pipeline of drug candidates that hold promise to be more effective and less toxic to healthy tissues than conventional drugs. Threshold's initial clinical focus is the treatment of cancer and benign prostatic hyperplasia, or BPH, a disease afflicting tens of millions of men worldwide. For additional information, please visit http://www.thresholdpharm.com.
Bionaut Pharmaceuticals and AnalytiCon Discovery Enter into a Lead Optimization Collaboration for a Novel Class of Anti-Cancer Compounds
Cambridge, MA and Potsdam, Germany – April 14, 2005
Bionaut Pharmaceuticals, Inc. and AnalytiCon Discovery GmbH announced today a service and collaboration agreement to identify novel anti-cancer compounds that inhibit the ability of tumor cells to survive stress conditions. Bionaut will provide to the collaboration a series of compounds that have shown potent in vivo activity in various human tumor xenograft models and use its Sentinel® Pathway Reporter System to validate new compounds. AnalytiCon will apply its natural product and medicinal chemistry expertise to optimize the activity and selectivity of these compounds for further pre-clinical development by Bionaut. Financial terms were not disclosed.
“We are delighted to have the chemistry team at AnalytiCon developing novel analogues for our lead program in cancer,” said Thomas Klein, Chief Operating Officer of Bionaut. “We believe their unique combination of expertise in natural products and analog medicinal chemistry will provide the fastest route to identify novel drug candidates to take forward towards human clinical studies.”
“The novel biological screening capabilities of Bionaut, combined with our exceptional integrated natural product-related expertise, make this a unique partnership,” said Lutz Müller-Kuhrt, Ph.D., CEO of AnalytiCon Discovery. “Bionaut's whole cell assays, which were used to identify this class of compounds that target tumor cells' response to stress, can also be used to rapidly validate the selectivity and efficacy of the compound analogues we develop for Bionaut.”
Bionaut's Cancer Program
Cellular signaling pathways regulate proliferation, angiogenesis and cell death. Cancer cells have adapted these pathways to allow tumors to survive and grow under stress conditions. In addition, exposure to most chemotherapeutic agents further induces stress. These treated cancer cells survive by secreting growth factors which are responsible for proliferation and angiogenesis and which block cell death.
Bionaut has applied its Sentinel® Pathway Reporter System to selectively measure the activity of cellular signaling pathways in cancer cells. Bionaut has identified BNC4, as well as other compounds in this class, which specifically inhibit the ability of cancer cells to grow under stress conditions in a variety of in vitro studies. Excellent in vivo activity has been demonstrated in human renal, pancreatic and non-small cell lung cancer xenograft models.
Bionaut Pharmaceuticals
Bionaut's business strategy is to discover novel small molecule drug candidates that affect well-validated disease pathways and to advance such discoveries through late stage pre-clinical status for further development in partnership with pharmaceutical and large biotechnology companies. Bionaut employs its patented Sentinel® Pathway Reporter System to initiate the discovery process. Bionaut's Sentinel system can greatly increase the chances of a positive clinical outcome for a new drug candidate by correlating pathway-specific interference directly with disease modulation in living human cells. Bionaut has applied the highly predictive capabilities of its Sentinel® system to build a pipeline of its own drug candidates in the areas of cancer and inflammation and continues to expand its efforts to other therapeutic areas. In addition, Bionaut will assist strategic partners with drug discovery and lead optimization in disease areas of their choice. More information about Bionaut can be found on the Company's website at www.bionautpharma.com.
AnalytiCon Discovery GmbH: (www.analyticon-discovery.com)
The internationally operating AnalytiCon Discovery GmbH is a worldwide marketleader in the field of structurally fully elucidated natural product libraries. On the basis of its ready-to-screen technology in the field of natural products (MEGAbolite®) and natural product analogues (NatDiverseTM) the company enjoys an exceptional market positioning. AnalytiCon has direct access to roughly a quarter of all known natural compounds worldwide, i.e. in their pure and structurally fully elucidated form. The company is able to offer its clients a complete Supply-Chain-Management from the initial biomaterial to the final lead compound.
GeneOhm Sciences Closes Follow-on Series C Funding from Partners Healthcare; Series C Adds Additional World Class Healthcare Investor
San Diego, CA – April 1, 2005
GeneOhm Sciences, an emerging leader in molecular diagnostics, announced that the company closed follow-on Series C funding with Partners HealthCare System, Inc. Partners HealthCare is an integrated healthcare system of advanced tertiary and community-based medical centers. It joins a syndicate of investors providing funding to accelerate the commercialization of GeneOhm's portfolio of molecular diagnostic products for applications in a number of areas, including rapid detection of bacterial infection and antimicrobial resistance.
Partners' founding members, Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH), have consistently been named to the U.S. News and World Report annual national hospital "Honor Roll". The system includes leaders in biomedical research and major teaching affiliates of the Harvard Medical School.
"We believe that GeneOhm's rapid, molecular diagnostic products can transform the practice and outcome of infection detection and control in a way that will make important improvements in health-economics and patient care. Their products provide significant advantages over standard, culture-based methods in time-to-result, performance and cost," said Jean Moses, Director of Corporate Development, Partners HealthCare.
"We are excited to welcome Partners HealthCare as an investor. Their commitment validates the importance of our products. GeneOhm Sciences has developed a proprietary platform for multiplexed molecular diagnostics for rapidly identifying and controlling infection and it supports our initiatives to transform patient care," commented Dr. Peter Klemm, President and CEO of GeneOhm Sciences.
About GeneOhm Sciences, Inc.
GeneOhm Sciences is a molecular diagnostic company with locations in San Diego, CA and Quebec City, Quebec, Canada. Its product portfolio includes two assays cleared by FDA and Health Canada for rapid detection of Group B Streptococcus (IDI-Strep B(TM)) and Methicillin-Resistant Staphylococcus aureus (IDI-MRSA(TM)) directly from clinical specimens. These are the first molecular diagnostic products to be cleared as meeting the specifications required to replace culture for microorganism detection. Future products include assays to detect vancomycin resistance and Methicillin sensitive staphylococcus aureus. GeneOhm's rich product pipeline is based on the company's broad portfolio of molecular-based technology for processing and detecting nucleic acids from a variety of specimens. These diagnostic products will serve unmet needs in a wide range of diseases, including infectious diseases, inherited diseases and oncology.
Bionaut Pharmaceuticals Continues to Build Management Team; Company to Present March 15th at the S.G. Cowen & Co. 25th Annual Healthcare Conference
Cambridge, MA – March 14, 2005
Bionaut Pharmaceuticals today announced the appointments of Gregory Gardiner Ph.D., former Group Director of R&D Operations, Pfizer Central Research and Director of Bionaut, to Chief Executive Officer and John M. Sorvillo, Ph.D., formerly Vice President of ArQule, to Chief Business Officer.
“Greg's and John's wealth of experience in research and drug development as well as in establishing corporate collaborations in the biotechnology and pharmaceutical industry is impressive,” states Timothy F. Howe, Bionaut director and partner with lead investor CHL Medical Partners. “Their skills are particularly important to our strategy at this time since we now have several programs nearing the partnering stage in cancer, macular degeneration and inflammation, in addition to our other programs in early development.”
Gregory Gardiner, Ph.D. was former Group Director of R&D Operations, Pfizer Central Research, where he designed and implemented Pfizer's external biotechnology strategy. Dr. Gardiner also participated in the management of Pfizer's worldwide drug discovery program, and was responsible for the scientific evaluation of licensing candidates including Lipitor, Celebrex, and Aricept. He currently serves as an advisor to Yale University's Office of Cooperative Research (OCR), a director of four biotech companies and a consultant and advisor to several investment funds and pharmaceutical and biotech companies.
John Sorvillo, Ph.D. served for nine years as Vice President of Business Development at ArQule, a Boston-based biotechnology company engaged in the research and development of small-molecule cancer therapeutics. During his time at ArQule, John was responsible for establishing many of ArQule's collaborations with major pharmaceutical companies. Prior to joining ArQule, for ten years, Dr. Sorvillo held a variety of scientific and business positions at OSI Pharmaceuticals, Inc. (Oncogene Science, Inc.) including his last position as Vice President and General Manager. Dr. Sorvillo attended the Massachusetts Institute of Technology Sloan School Program for Senior Executives. He was a postdoctoral fellow at Memorial Sloan Kettering Cancer Center, received his Ph.D. in Immunology from the New York University Medical Center and his B.A. in Biology from the City University of New York, Hunter College.
“John's demonstrated success in establishing high-value business development deals at both ArQule and OSI will be a tremendous asset for Bionaut as we embark on partnerships for our lead programs,” stated Gregory Gardiner, Ph.D, Director and Chief Executive Officer of Bionaut.
Bionaut Pharmaceuticals will be presenting at the S.G. Cowen & Co. 25th Annual Healthcare Conference at 3:30 PM on March 15th at the Marriott Copley Place in Boston.
About Bionaut Pharmaceuticals
Bionaut's business strategy is to discover novel small molecule drug candidates that affect well-validated disease pathways and to advance such discoveries through late stage pre-clinical status for further development in partnership with pharmaceutical and large biotechnology companies. Bionaut employs its patented Sentinel Pathway Reporter System™ to initiate the discovery process. Bionaut's Sentinel system can greatly increase the chances of a positive clinical outcome for a new drug candidate by correlating pathway-specific interference directly with disease modulation in living human cells. Bionaut has applied the highly predictive capabilities of its Sentinel system to build a pipeline of its own drug candidates in the areas of cancer and inflammation and continues to expand its efforts to other therapeutic areas. In addition, Bionaut will assist strategic partners with drug discovery and lead optimization in disease areas of their choice. More information about Bionaut can be found on the Company's website at www.bionautpharma.com.
Cellular Genomics Appoints Dr. Peter Fuller Chief Business Officer
Branford, CT – (PRNewswire) – March 9, 2005
Cellular Genomics Inc. (CGI), a chemical genetics based biopharmaceutical company developing novel targeted therapeutics for cancer and angiogenesis, as well as allergic, autoimmune, and inflammatory diseases, today announced that Peter A. Fuller, Ph.D., has joined the Company in the newly created position of Chief Business Officer, reporting to Louis A. Matis, M.D., President and Chief Executive Officer. Prior to joining CGI, Dr. Fuller was Senior Vice President, Business Development, at Molecular Staging, Inc.
"We are extremely pleased to have Peter join the management team at CGI, as he brings to the company broad knowledge of multiple facets of business and corporate development within a biotechnology setting," said Dr. Matis. "His extensive record of accomplishments encompasses product licensing, technology assessment, as well as research and development, all of which will prove to be invaluable as we increasingly leverage the partnering opportunities for our unique drug discovery capabilities and therapeutic programs."
Dr. Fuller, 50, has more than two decades of broad-based experience in the biotechnology industry. At Molecular Staging, Inc., Dr. Fuller was responsible for building and formalizing the company's business development functions, including the development and execution of short and long-term corporate development objectives, goals and strategies, as well as prioritizing technology, licensing, product development and marketing initiatives. Prior to joining Molecular Staging in 2001, Dr. Fuller was with Curagen Corporation since 1998, where first as Vice President and later, Senior Vice President, Business Development he had broad responsibility for business development and research and development. From 1983 to 1997, Dr. Fuller held positions of increasing responsibility at Pioneer Hi-Bred International, Inc., where he directed technology strategic planning activities, identified strategic alliance partners to meet the company's diverse product goals and was responsible for multiple licensing and R&D collaboration agreements. Dr. Fuller received his BS degree at the California State University at Chico and his MS and Ph.D. degrees from the University of Nebraska where he studied biometrical genetics.
"I am excited to be joining CGI at this critical juncture in the Company's growth," said Dr. Fuller. "CGI's drug discovery capabilities and growing pipeline of novel drug candidates are highly promising, and I look forward to applying my skills to lead CGI's business development initiatives."
About CGI
Cellular Genomics Inc. (CGI) is a privately held genomics-based biopharmaceutical company with rapidly advancing drug development programs in oncology, angiogenesis, allergy, autoimmunity, and inflammation. CGI's proprietary technologies, including the company's unique, highly integrated chemical genetics ASKA (Analog Sensitive Kinase Allele) and state-of-the-art High-throughput Accelerated Lead Optimization (HALO) platforms, have demonstrated broad application across all phases of drug discovery, providing the company with key competitive advantages in identifying kinase inhibitors for multiple clinical indications. CGI is leveraging its broad capabilities to advance its own internal drug development programs as well as to establish partnerships with pharmaceutical and biotechnology companies. The Company has established research collaborations with Affymetrix, Eli Lilly and Company, Pfizer Inc., Schering AG, and Serono SA. Please visit http://www.cellulargenomics.com for additional information.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials and the risk that the company will not obtain approval to market its products.
Cellular Genomics Achieves Key Milestone in Its Joint Kinase Discovery Program With Serono
Branford, CT – (PRNewswire) – 2/15/05
Cellular Genomics Inc. (CGI), a chemical genetics based drug discovery and development company, today announced the completion of a key performance milestone in its joint kinase discovery program with Serono. Under the alliance, CGI has been applying its proprietary chemical genetics Analog Sensitive Kinase (ASKA) technology to a number of target kinases selected by Serono. The milestone relates to the successful development of CGI's unique in vivo models for kinase drug discovery. The completion of the milestone entitles CGI to a performance payment.
“We are pleased to have achieved this important milestone in our collaboration with Serono," said Louis Matis, M.D., President and Chief Executive Officer of CGI. "The promise of the ASKA technology and its broad utility for kinase drug discovery is already being realized in our own drug discovery programs at CGI, where we have utilized the in vivo ASKA model to validate a key kinase target, confirm its safety, and identify a robust pharmacodynamic marker for benchmarking the efficacy of our promising lead candidates. To date, we and our partners have now successfully produced 12 in vivo ASKA models spanning multiple kinase families and addressing a broad range of potential clinical indications."
CGI's cutting-edge approach to kinases is based on the discovery of ASKAs, which are genetically modified kinases that retain all the functions of normal kinases, and can be potently and specifically inhibited by a proprietary small molecule analog inhibitor. The technology has been utilized to develop an unprecedented in vivo model for kinase drug discovery that makes it possible to perform pharmaceutically relevant dose- and time-dependent, reversible in vivo inhibition of kinases. This provides ASKA with strong competitive advantages in multiple aspects of kinase drug discovery, including target validation, therapeutic index determination, drug safety evaluation, identification of pharmacodynamic markers to benchmark lead candidates, and biomarker discovery.
"We are delighted to have the opportunity to use these unique in vivo models to support our kinase drug discovery programs," said Christian Rommel, Ph.D., Head of the Signal Transduction Laboratory at Serono. "Kinases are an important family of targets in Serono's small molecule drug discovery programs and we look forward to working with CGI's' ASKA technology to study kinase targets for our chosen disease areas."
About CGI
Cellular Genomics Inc. (CGI) is a privately held drug discovery and development company that has pioneered a unique, highly integrated chemical genetics platform (Analog Sensitive Kinase Allele, or ASKA, technology) to discover and develop kinase inhibitors for multiple clinical indications. CGI has established state-of-the art small molecule drug discovery capabilities, including proprietary chemical libraries generated through the company's High-throughput Accelerated Lead Optimization (HALO) platform. CGI has generated potent, selective lead candidates in autoimmune/inflammatory disease, and cancer/angiogenesis programs that are advancing rapidly to the clinic. CGI's proprietary chemical genetics technologies have broad applications across all phases of drug discovery, which the company is leveraging both to advance its own internal drug development programs, as well as to establish partnerships with pharmaceutical and biotechnology companies. The Company has established research collaborations with Affymetrix, Eli Lilly and Company, Pfizer Inc., Schering AG, and Serono SA. Please visit http://www.cellulargenomics.com for additional information.
This news release contains certain forward-looking statements that involve risks and differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials and the risk that the company will not obtain approval to market its products.
Threshold Pharmaceuticals Announces Initial Public Offering
Redwood City, CA – February 4, 2005
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) announced today its initial public offering of 5,333,333 shares of common stock at a price of $7 per share. All of the shares are being offered by Threshold. The shares will trade on the NASDAQ National Market under the symbol “THLD”.
The joint book-running managers for the offering are Banc of America Securities LLC and CIBC World Markets Corp., and Lazard Frères & Co. LLC and William Blair & Company, L.L.C. are acting as co-managers for the offering. Threshold has granted the underwriters a 30-day option to purchase an additional 800,000 shares of common stock at the initial public offering price to cover over-allotments, if any. Copies of the final prospectus relating to this offering may be obtained from either Banc of America Securities at 9 West 57th Street, New York, New York 10019, Attention: Legal Department or CIBC World Markets Corp., by email at useprospectus@us.cibc.com or by fax at 212-667-6136.
Threshold, based in Redwood City, California, is focused on the discovery, development, and commercialization of small molecule therapeutics based on “Metabolic Targeting”. This approach targets abnormal glucose metabolism - a fundamental property of most solid tumors and other diseases. The company's initial focus is the treatment of cancer and benign prostatic hyperplasia (BPH), a disease characterized by overgrowth of the prostate.
The registration statement relating to the initial public offering of common shares has been declared effective by the Securities and Exchange Commission. This press release does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of such common shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state. The offering of these securities will be made only by means of a prospectus.
Amicus Therapeutics Appoints John F. Crowley Chairman and CEO; New Executives Named to Management Team
North Brunswick, NJ – January 24, 2005
Amicus Therapeutics, an emerging biopharmaceutical company, today announced the appointment of John F. Crowley as chairman and CEO. Mr. Crowley was most recently founding president and CEO of Orexigen Therapeutics. Prior to this Mr. Crowley was senior vice president of Genzyme Therapeutics and founding president and CEO of Novazyme Pharmaceuticals.
Amicus develops orally-active, small molecule drugs to treat a broad range of human genetic diseases. Recent work has shown that many of these diseases are the result of genetic errors that cause the misfolding and loss of a particular protein. Amicus' products act as "pharmacological chaperones" that selectively bind and "rescue" the misfolded target protein in order to restore its natural function. Amicus' first drug in the clinic, AT1001, is being developed to treat Fabry disease and is currently being studied in a Phase I clinical trial. The company has a strong intellectual property position and active research and development programs for multiple additional diseases.
"Amicus represents a remarkable opportunity," said Mr. Crowley. "Utilizing Amicus' core technology, proprietary systems and intellectual property, we will create small molecule drugs to treat a very large number of genetically based diseases. We intend to address multiple patient populations with dramatic unmet medical needs and we will do so at a very rapid pace. I am eager to lead this team and am honored by the trust and confidence that Amicus' investors have placed in me."
Also joining the company's management team are Matthew Patterson as chief business officer and Gregory Licholai, M.D., as vice president of medical affairs and corporate development. Norman Hardman, Ph.D., who had been serving as the Amicus CEO, will assume the position of chief scientific officer.
Prior to Amicus Mr. Patterson worked for BioMarin Pharmaceutical Inc. from 1998-2004 where he was vice president, regulatory affairs and later vice president, commercial planning. At BioMarin Mr. Patterson oversaw the development of Aldurazyme® (laronidase) for the treatment of MPS I and initiated the sales and marketing functions for genetic diseases. From 1993-1998 Mr. Patterson worked for Genzyme Corporation.
Before coming to Amicus Dr. Licholai was a venture capitalist at Domain Associates where he helped fund biotechnology and medical device start-up companies. Previously he was director of ventures and business development for Medtronic Neurological, where he managed a global portfolio of drug delivery and neurological projects. He trained at Harvard Medical School, the Brigham and Women's, Children's and Massachusetts General Hospitals.
"The addition of these highly experienced senior managers will enable Amicus to rapidly advance its preclinical and development pipeline programs and will support the company as it develops the wealth of opportunities its unique therapeutic approach makes possible," said Alex Barkas, Ph.D., managing director of Prospect Venture Partners and a member of the Amicus board of directors. "The board looks forward to working with the expanded management team to accelerate development and commercialization of this important new technology."
Amicus was founded in 2002. In mid-2004, the company completed a $31 million series B financing led by Canaan Partners, with participation from Frazier Healthcare Ventures, New Enterprise Associates, Prospect Venture Partners and Radius Ventures. The company's founding investor, CHL Medical Partners, also participated in the round.
About Amicus Therapeutics
Amicus develops orally-active, small molecule drugs to treat a broad range of human genetic diseases. Many of these diseases are the result of genetic errors that cause the misfolding and loss of a particular protein. Amicus' products act as "pharmacological chaperones" that selectively bind and "rescue" the misfolded target protein, in order to restore its natural function. The company‘s first compound, AT1001, is in a Phase I clinical trial for Fabry disease. Additional information about Amicus can be found at www.amicustherapeutics.com.
GeneOhm Sciences Completes a $14 Million Second Closing of Series C Financing for a Total of $26 Million; Series C Success Adds Additional World Class Investors
San Diego, CA – (Business Wire) – January 18, 2005
GeneOhm Sciences, a leader in molecular diagnostics, announced that the company has successfully raised $14 million in a second closing of its Series C financing, bringing the total Series C to $26 million. The first closing was completed on November 24, 2004 in conjunction with the merger of GeneOhm and Infectio Diagnostic, (I.D.I.), Inc. It was followed closely by the second closing, which was finalized on December 17, 2004.
New investors include Kaiser Permanente Ventures, QuestMark Partners and Posco BioVentures. Existing investors include Domain Associates, SGF Sante Inc., CHL Medical Partners, CB Health Ventures and CDIB. The funds will be used to accelerate commercialization of the company's proprietary technologies in molecular diagnostics for pathogens that cause infectious disease, genetic mutations linked to inherited disease and oncology.
"We think GeneOhm's rapid molecular assay can accelerate diagnoses and laboratory processes -- filling clinical needs and reducing cost structure," noted Bob Ward, Practice Leader at Kaiser Permanente Ventures.
"We are excited about introducing GeneOhm to our network of hospitals because we believe GeneOhm's products in infection control will address serious issues facing hospitals and their patients," comments Benjamin S. Schapiro, Partner at QuestMark Partners.
"The potential of GeneOhm's products is very exciting both in the US and abroad. We look forward to leveraging our relationships in Asia to aid GeneOhm in expanding their market development," quoted Charlotte Clark, Managing Member of Posco BioVentures.
"We are thrilled to add these world class investors including Kaiser Permanente, a world leader in the area of preventive healthcare. The commitment of each investor and Kaiser's participation are strong signs of the importance of our products and technologies," said Dr. Peter Klemm, President and CEO of GeneOhm Sciences.
About GeneOhm Sciences, Inc.
GeneOhm Sciences is a molecular diagnostic company with locations in San Diego, CA and Quebec City, Quebec, Canada. Its product portfolio includes two assays cleared by FDA and Health Canada for rapid detection of Group B Streptococcus (IDI-Strep B(TM)) and Methicillin-Resistant Staphylococcus aureus (IDI-MRSA(TM)) directly from clinical specimens. These are the first molecular diagnostic products to be cleared as meeting the specifications required to replace culture for microorganism detection. GeneOhm's rich product pipeline is based on the combination of the company's proprietary technology for nucleic acid detection and its broad molecular IP. These diagnostic products will serve unmet needs in a wide range of diseases, including infectious diseases, inherited diseases and oncology.
Threshold Pharmaceuticals Appoints Alan Colowick, M.D. As Chief Medical Officer
Redwood City, CA - January 18, 2005
Threshold Pharmaceuticals today announced that Alan Colowick, M.D. has been named Chief Medical Officer (CMO).
From 1999 to 2005, Dr. Colowick held a variety of positions with Amgen, most recently as vice president of European Medical Affairs, where he managed a regional, cross-functional medical affairs organization with responsibilities for all of Amgen's therapeutic areas. Prior to that, Dr. Colowick worked as senior director of Medical Affairs, leading the team through a Biologics License Application/Marketing Authorization Application (BLA/MAA) and approval for Aranesp® in the United States, European Union and Australia. He also had served at Amgen as director of product development and product development team leader in addition to overseeing the international clinical studies management.
Dr. Colowick received his M.D. from Stanford University School of Medicine and his M.P.H. from the Harvard School of Public Health. He completed his sub-specialty training in hematology and oncology at Brigham and Women's Hospital and the Dana Farber Cancer Institute.
About Threshold Pharmaceuticals
Threshold Pharmaceuticals is focused on the discovery, development, and commercialization of small molecule therapeutics based on “Metabolic Targeting”. This approach targets abnormal glucose metabolism - a fundamental property of most solid tumors and other diseases. The Company's initial focus is the treatment of cancer and benign prostatic hyperplasia (BPH), a disease characterized by overgrowth of the prostate. Metabolic Targeting provides the opportunity to treat not only rapidly dividing tumor cells, but also the slowly dividing tumor cells that generally evade traditional therapies and ultimately contribute to relapse.
Select Medical Corporation Completes Acquisition of SemperCare, Inc.
Mechanicsburg, PA – (PRNewswire-FirstCall) - January 3, 2005
Select Medical Corporation (NYSE: SEM - News) today announced that it has completed the transaction to acquire SemperCare, Inc. ("SemperCare"). SemperCare, based in Plano, Texas, operates 17 long-term acute care hospitals in 11 states.
Select Medical Corporation is a leading operator of specialty hospitals in the United States. Following its acquisition of SemperCare, Select operates 99 long-term acute care hospitals in 26 states. Select operates four acute medical rehabilitation hospitals in New Jersey. Select is also a leading operator of outpatient rehabilitation clinics in the United States and Canada, with approximately 750 locations. Select also provides medical rehabilitation services on a contract basis at nursing homes, hospitals, assisted living and senior care centers, schools and worksites. Information about Select is available at http://www.selectmedicalcorp.com.
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