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Threshold Pharmaceuticals Initiates Phase 1/2 Trial Evaluating Glufosfamide As First-Line Pancreatic Cancer Therapy
South San Francisco, CA – December 20, 2004
Threshold Pharmaceuticals, Inc. (www.thresholdpharm.com) announced today that it has initiated patient enrollment for a Phase 1/2 clinical trial evaluating the dosing, safety and activity of Glufosfamide in combination with gemcitabine for treating advanced solid malignancies or as a first line treatment for pancreatic cancer.
Phase 1 of the Glufosfamide/gemcitabine study will evaluate various doses of Glufosfamide in combination with the standard dose of gemcitabine in patients with any kind of advanced solid malignancy for which gemcitabine is currently a treatment option. The Phase 1 portion of this study may enroll up to 15 patients. The maximum tolerable dose combination determined in Phase 1 of the study will be used in the Phase 2 portion to treat patients with pancreatic cancer. Approximately 47 men and women with advanced pancreatic cancer will be enrolled in the Phase 2 clinical trial at various sites in the U.S. and Latin America.
Earlier this year, Threshold announced the initiation of a pivotal Phase 3 clinical trial to evaluate Glufosfamide in patients with metastatic pancreatic cancer refractory to first-line treatment. The data from that trial will be evaluated under a Special Protocol Assessment (SPA) granted by the FDA.
“With so few effective first-line therapies available for pancreatic cancer patients, our hope is that the Glufosfamide/gemcitabine combination will emerge as the powerful new therapy these patients so desperately need,” said George Tidmarsh, M.D., Ph.D. and president of Threshold Pharmaceuticals.
Results from previous Phase 1 and 2 clinical trials have demonstrated that Glufosfamide shows activity against pancreatic cancer. In an initial Phase 1 trial of Glufosfamide in patients with a variety of solid tumors, published in the Journal of Clinical Oncology (Oct. 2000), the only pancreatic cancer patient enrolled in the trial achieved a complete remission of disease and remained in remission more than five years after receiving Glufosfamide treatment alone.
In a Phase 2 trial of Glufosfamide for the treatment of advanced pancreatic cancer, two of the 34 patients achieved a partial response (defined as 30% or greater tumor diameter shrinkage), and 11 of 34 patients achieved stable disease (defined as less than 30% tumor diameter shrinkage and less than 20% growth in tumor diameter). Overall two-year survival was estimated at nine percent, which compares to one percent or less in historical studies with other first-line therapies. In addition, in animal studies Glufosfamide and gemcitabine have been safely administered in combination and have demonstrated anti-cancer activity greater than either drug alone.
About Threshold Pharmaceuticals
Threshold Pharmaceuticals, Inc. (www.thresholdpharm.com), is focused on the discovery, development, and commercialization of small molecule therapeutics based on “Metabolic Targeting.” This new approach targets abnormal glucose metabolism - a fundamental property of most solid tumors and many 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. In cancer, 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.
The National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health, Inc. Announce Positive Study Results Demonstrating Oncotype DX Genomic Breast Cancer Assay Predicts Chemotherapy Response
San Antonio, CA – (PR Newswire) – December 10, 2004
– New England Journal of Medicine Publishes NSABP Validation Study of Oncotype DX That Quantifies Likelihood of Recurrence in Early Stage Breast Cancer Patients –
– Kaiser Permanente Presents Results From Large Community-Based Study Consistent With NSABP Recurrence Study Findings –
– Live Teleconference to Discuss These Findings at San Antonio Breast Cancer Symposium –
The National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health, Inc. today announced positive results of a new study demonstrating that the Oncotype DX(TM) 21-gene panel that quantifies the likelihood of breast cancer recurrence for a large portion of early stage breast cancer patients also predicts the magnitude of chemotherapy benefit in these patients. These findings challenge the common assumption that all women benefit similarly from chemotherapy. The new study results were presented today at the 27th Annual San Antonio Breast Cancer Symposium (SABCS) and coincide with the New England Journal of Medicine publication of the NSABP validation study demonstrating that Oncotype DX quantifies the likelihood of recurrence in node-negative, estrogen receptor-positive breast cancer.
"Our study discloses that the same 21-gene panel that we demonstrated could quantify breast cancer recurrence, can also predict response to chemotherapy," 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. "These data advance the state of the art in cancer care and call for a reevaluation of treatment practice. By using the Oncotype DX assay, physicians can more effectively optimize a treatment plan and avoid under treating and over treating breast cancer patients," said Dr. Wolmark.
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 these patients.
"These studies represent a major advance in our understanding of the role of molecular profiling in breast cancer treatment, work that is critical in our national efforts to fight cancer," said Dr. JoAnne Zujewski, head, Breast Cancer Therapeutics, Clinical Investigations Branch, National Cancer Institute (NCI). "The development of this test reflects the cooperative efforts of breast cancer research groups, patient advocacy, industry, and the federal cancer research program. NCI's longstanding support of the clinical trial process and tumor tissue banks took years off the process needed to gather data to validate the test."
New England Journal of Medicine Publishes NSABP Validation Study
The NSABP and Genomic Health also announced today that the New England Journal of Medicine published the results of their large-scale, validation trial demonstrating that the Oncotype DX 21-gene assay quantifies the likelihood of breast cancer recurrence in a large portion of early stage patients.
The Journal is publishing the study today online as an "early release" to coincide with the NSABP data presentations at SABCS. The same study will appear in the December 30 print edition.
The study showed that the "Recurrence Score" determined by Oncotype DX provides a level of correlation to breast cancer recurrence that exceeds standard measures, such as patient age, tumor size and tumor grade. Importantly, the results indicate that approximately 50 percent of patients are reclassified (from low risk to higher risk, or from higher risk to low risk) by the Recurrence Score when compared to classification by existing guidelines based on the standard measures. These data, originally presented at the 26th Annual San Antonio Breast Cancer Symposium in 2003, represent the first large-scale, multi-center validation of a multi-gene assay.
"The Oncotype DX assay has been extensively evaluated in numerous independent studies involving over 2,600 breast cancer patients, including the large validation study now in the peer-reviewed New England Journal of Medicine," said Steven Shak, M.D., chief medical officer of Genomic Health, Inc. "We believe the Oncotype DX assay will become a standard of care in breast cancer, providing critical information to help physicians and patients make potentially life changing treatment decisions," said Dr. Shak.
NSABP and Genomic Health performed a blinded validation trial with prospectively-defined endpoints using surgical tissue samples from 668 tamoxifen-treated patients, who had node-negative, estrogen receptor-positive breast cancer. These tissue samples were from patients who enrolled in the NSABP B-14 clinical trial from 1982-1988 and whose outcomes have been tracked over time by NSABP sites. This was the first time that such a study had been conducted using thin sections from standard diagnostic pathology specimens (fixed paraffin-embedded tissue) that are routinely available. Using quantitative RNA analysis of tumor tissues, the study evaluated the ability of the 21-gene Oncotype DX Recurrence Score assay to determine the likelihood of breast cancer recurrence. The Recurrence Score was able to accurately assign individual patients into high and low risk groups (p<0.001), and when the Recurrence Score was examined together with age and tumor size in a multivariate analysis, the Recurrence Score was the strongest independent predictor of recurrence (p<0.001).
The NSABP validation study and the NSABP B-20 chemotherapy benefit study looked at a specific population of breast cancer patients, those with node-negative, estrogen receptor-positive tumors who were treated with tamoxifen. This is a substantial patient population, comprising about 50 percent of all newly diagnosed breast cancer patients in the United States each year.
The NSABP validation study showed that using multiple genes is more powerful than using single genes and will provide more consistent and reliable information for physicians and patients. The 21-gene panel includes genes related to critical pathways that breast cancer cells depend on, including the estrogen receptor, HER2 and proliferation as well as several other important pathways.
Oncotype DX is the only multi-gene assay currently available to physicians.
"Taken together, these studies conducted by the NSABP in collaboration with Genomic Health have demonstrated that only a subset of patients with early breast cancer identified by Oncotype DX derive benefit from chemotherapy and for those patients the benefit is striking (absolute reduction of the chance of disease recurrence in 10 years of more than 28%)," said Soonmyung Paik, M.D., director of the NSABP Division of Pathology and lead author of the paper published in the New England Journal of Medicine. This is a major breakthrough for the individualized treatment of patients diagnosed with early breast cancer," continued Dr. Paik.
"The introduction of the Oncotype DX assay has made individualized medicine a reality today in doctor's offices across the country," said Randy Scott, Ph.D., chairman and CEO of Genomic Health, Inc. "We will continue our research efforts applying sophisticated genomic technology to the fundamental and crucial step of diagnosis in order to continue to make improvements in cancer treatment," said Dr. Scott.
Northern California Kaiser Permanente Study Concurs with NSABP Findings
Northern California Kaiser Permanente presented findings yesterday at the SABCS from a community-based study from 14 Northern California hospitals. 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 mortality (p<0.001). The assay provided information that goes beyond tumor size and tumor grade. In addition, the Oncotype DX assay identifies a large proportion of these women who have a very low risk (less than 3 percent) of breast cancer death at 10 years. These new results in a community-based patient population representing approximately one percent of the U.S. population were similar to those from the large clinical validation trial conducted previously by the National Surgical Adjuvant Breast and Bowel Project (NSABP).
NSABP B-14 tamoxifen benefit study
Genomic Health and NSABP studied the 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 can predict pure prognosis, responsiveness to hormonal therapy, or both. Results of the study 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.
Live/Audio Teleconference
A live teleconference featuring speakers from NSABP, NCI, Genomic Health and Y-ME National Breast Cancer Organization will take place Friday, December 10 at 11:45 a.m. (Central Time) at the Henry B. Gonzalez Convention Center in San Antonio, TX. For more information about participating in person or by phone please call Kathleen Rinehart at 408-460-9116.
The NSABP is a not-for-profit, clinical trials cooperative group, which includes a network of over 500 professionals located in the U.S., Canada and Puerto Rico. Research conducted by the NSABP is supported primarily by grants from the NCI. For more than 40 years, the NSABP has successfully conducted large-scale, randomized clinical trials in colorectal and breast cancer that have altered and improved the standard of care for men and women with these diseases. To learn more about the NSABP, please visit http://www.nsabp.pitt.edu.
Genomic Health, Inc. is a health care services company that employs sophisticated genomic research to develop clinically validated molecular diagnostics. Genomic Health's goal is to provide individualized information on the likelihood of disease recurrence and response to therapy in order to improve the quality of treatment decisions for patients with cancer. Genomic Health has the financial backing of some of the world's leading capital and financial institutions, including Kleiner Perkins Caufield & Byers, JP Morgan, Versant Ventures, Texas Pacific Group and Baker/Tisch. The company was founded in August 2000 and is located in Redwood City, California. For more information about the company, please visit http://www.genomichealth.com.
Molecular Test Can Predict Both the Risk of Breast Cancer Recurrence and Who Will Benefit From Chemotherapy
NIH - National Cancer Institute (NCI) – December 10, 2004
A new test can predict both the risk of breast cancer recurrence and may identify women who will benefit most from chemotherapy, according to research supported by the National Cancer Institute (NCI), part of the National Institutes of Health, and performed in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health Inc. These results suggest that almost half of 43,000 U.S. women diagnosed with estrogen-dependent, lymph-node negative breast cancer* every year are at low risk for recurrence and may not need to go through the discomfort and side effects of chemotherapy.
The test is based on levels of expression (increased or decreased) of a panel of cancer-related genes. This panel is used to predict whether estrogen-dependent breast cancer will come back, according to a study that will be published online in the New England Journal of Medicine on Friday, December 10, 2004**. Scientists on this study also will present new results on that day at San Antonio Breast Cancer Symposium indicating that the same test can predict which women benefit most from chemotherapy. Women with low risk of breast cancer recurrence-about half of the women in the recent study-do not appear to derive much benefit from chemotherapy.
The researchers used tissue samples and medical records from women enrolled in clinical trials of the cancer drug tamoxifen, which blocks the effect of estrogen on breast cancer cells. These women had a kind of breast cancer defined as estrogen receptor-positive, lymph node-negative. Each year, 43,000 women are diagnosed with this kind of breast cancer, which needs estrogen to grow but has not spread to the lymph nodes. Currently, many women with this type of breast cancer in the United States do receive chemotherapy in addition to hormonal therapy.
Using samples from 447 patients and a collection of 250 genes in three independent preliminary studies, 16 cancer-related genes were found that worked best. The scientists created a formula that generates a "recurrence score" based on the expression patterns of these genes in a tumor sample. Ranging from 1 to 100, the recurrence score is a measure of the risk that a given cancer will recur***.
Prior to this research, analysis of the expression of genes was performed on tumor specimens that were frozen rather than tissue prepared for routine pathologic evaluation (fixed and embedded). The expression analysis depended on measurement of RNA (the molecule necessary for the translation of a gene into a protein), and RNA is altered when tissues are fixed and embedded. Frozen tissues are generally not readily available in routine practice. Researchers at Genomic Health, Inc. developed a method for performing these analyses on tissues embedded in paraffin wax. Their method allows them to use the altered RNA that is found in fixed tissue.
The results published in the New England Journal of Medicine validate the ability of the recurrence score to predict risk of recurrence. Using biopsy tissue and medical records from another NSABP tamoxifen trial, researchers divided 668 women into low, intermediate, and high risk of recurrence groups. Fifty-one percent were in the low risk group (with a score of less than 18); 22 percent were at intermediate risk (recurrence score 18 or higher but less than 31); 27 percent were at high risk (a score of 31 or higher).
These risk group divisions correlated well with the actual rates of recurrence of breast cancer after 10 years. There was a significant difference in recurrence rates between women in the low and high risk groups. In the low risk group, there was a 6.8 percent rate of recurrence at 10 years; in the intermediate and high risk categories these rates were 14.3 and 30.5 percent, respectively. Up to a recurrence score of 50, rates of recurrence increased continuously as the recurrence score increased. These trends held across age groups and tumor size.
"These results were generated perhaps a decade earlier than would have been possible if the researchers had not had access to biopsy tissue from the NSABP trials," notes Sheila E. Taube, Ph.D., associate director of NCI's Cancer Diagnosis Program.
The same 21-gene test has also been used to predict how beneficial chemotherapy will be for women with estrogen receptor-positive, lymph node-negative breast cancer for women on tamoxifen in NSABP trials. These results will be presented at the San Antonio Breast Cancer Symposium on December 10, 2004.
"NCI staff worked with the company, NSABP and experts from other NCI Cooperative Groups to develop an overall strategy to validate the test; this plan was fruitful and may lead to providing an important tool for physicians and women to use in considering breast cancer treatment decisions," said Taube.
In the treatment study, women with high recurrence scores, who are representative of about 25 percent of patients with this kind of breast cancer, had a large benefit from chemotherapy in terms of 10 year recurrence-free rates. Women with low recurrence scores, who represent about 50 percent of these patients, derived minimal benefits from chemotherapy. The group under study was not large enough to determine whether chemotherapy is detrimental to the low risk group.
"The test has the potential to change medical practice by sparing thousands of women each year from the harmful short- and long-term side effects associated with chemotherapy," said JoAnne Zujewski, M.D., senior investigator in NCI's Cancer Therapy Evaluation Program.
Kaiser Permanente Research: Study of Early Stage Breast Cancer Patients Identifies Women at Low Risk of Breast Cancer Mortality; 21-Gene Test Predicts Mortality Risk in Epidemiological Study
San Antonio, CA – December 9, 2004
Kaiser Permanente researchers are presenting results of a large epidemiologic study of a unique breast cancer test at the 27th Annual San Antonio Breast Cancer Symposium. The KP study shows the test can identify patients with early stage disease who are at low risk of breast cancer death at 10 years.
Researchers at Kaiser Permanente designed a population-based, case-control study that evaluated node-negative, non-chemotherapy-treated breast cancer patients diagnosed between 1985 and 1994 at 14 Northern California Kaiser hospitals. The study among KP members (790 cases and controls) included many patients with small tumors, as seen in current practice -- more than 30 percent had tumors less than or equal to 1 cm in size.
The results of the study showed a strong and graded association between the Oncotype DX "Recurrence Score" and 10-year breast cancer mortality (p<0.001). These new results in a community-based patient population representing approximately one percent of the U.S. population were similar to those from the large clinical validation trial conducted previously by the National Surgical Adjuvant Breast and Bowel Project (NSABP).
"Our study is significant because it reinforces the NSABP validation study findings but in a community-based patient population," said Laurie Habel, Ph.D. leader of the Northern California Kaiser Permanente study. "The results demonstrate a strong and graded association with breast cancer mortality.
Using quantitative RNA analysis of tumor tissues, the study evaluated the Oncotype DX breast cancer assay and compared its use with standard measures of tumor size and tumor grade. The assay provided information that goes beyond tumor size and tumor grade. In addition, the assay identifies a large proportion of women who have a very low risk (less than 3 percent) of breast cancer death at 10 years.
The Kaiser study is one of the first to evaluate a multi-gene panel in a large community-based cancer patient population. The assay, Oncotype DX, used in this study includes 21 genes related to the estrogen receptor, HER2, proliferation and invasion as well as several other carcinogenic pathways. Oncotype DX assay has been developed and validated by Genomic Health in multiple independent studies involving over 2,600 patients. Kaiser Permanente's study was sponsored by Genomic Health Inc.
Kaiser Permanente has research departments in California, Oregon, Hawaii, Georgia, Colorado, Maryland, and Ohio. Results of research conducted by Kaiser Permanente physicians and investigators have been published in the Journal of the American Medical Association, the New England Journal of Medicine, the Permanente Journal, the American Journal of Public Health, Pediatrics, and other clinical journals.
Kaiser Permanente is America 's leading integrated health plan. Founded in 1945, it is a not-for-profit, group practice prepayment program with headquarters in Oakland , California . Kaiser Permanente serves the health care needs of over 8.3 million members in 9 states and the District of Columbia. Today it encompasses Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the Permanente Medical Groups, as well as an affiliation with Group Health Cooperative based in Seattle.
Nationwide, Kaiser Permanente includes approximately 134,000 technical, administrative and clerical employees and 11,000 physicians representing all specialties.
Select Medical Corporation Signs Agreement to Acquire SemperCare, Inc.
Mechanicsburg, PA – (PRNewswire-FirstCall) – November 19, 2004
Select Medical Corporation (NYSE: SEM - News) today announced the signing of a definitive agreement to acquire SemperCare, Inc., a privately held company based in Plano, Texas, for approximately $100 million in cash. The purchase price is subject to adjustment based on SemperCare's net working capital on the closing date.
SemperCare operates 17 long-term acute care hospitals in 11 states. SemperCare's revenues for calendar 2003 and the nine months ended September 30, 2004 were approximately $83.0 million and $110.6 million, respectively. The transaction, which is expected to close in the first quarter of 2005, is subject to a number of closing conditions, including receipt of regulatory approvals. Robert A. Lefton, SemperCare's Co-founder, President and Chief Executive Officer, and Gary A. Kagan, SemperCare's Co-founder and Executive Vice President of Development, will remain with SemperCare as employees after the transaction is completed.
Select Medical Corporation is a leading operator of specialty hospitals in the United States . Select operates 82 long-term acute care hospitals in 25 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/.
Invitrogen Launches World's First Commercially Available High-Density Human Protein Microarray; ProtoArray(TM) Human Protein Microarray Screens Thousands of Pharmaceutically Relevant Proteins In a Single, Rapid Experiment
Carlsbad, CA – (BUSINESS WIRE) – November 18, 2004
Invitrogen Corporation (Nasdaq:IVGN), a provider of essential life science technologies for disease research and drug discovery, today unveiled the world's first commercially available microarray optimized for maximally functional proteins – the ProtoArray(TM) Human Protein Microarray. This high-density protein microarray, containing more than 1,800 unique human proteins, represents a cross-section of gene families including pharmaceutically relevant protein classes such as kinases, membrane-associated, cell-signaling and metabolic proteins. The ProtoArray allows identification of protein-protein interactions in as little as four hours as contrasted with the weeks required for similar experiments to date.
Invitrogen's latest offering is the first high-density array containing a high percentage of functional human proteins. Using Invitrogen's proprietary ProtoP5(TM) expression and purification technology, proteins on the ProtoArray slide retain superior activity profiles when compared to arrays produced using E. Coli based expression methods.
"Making a protein microarray like the ProtoArray available to the market means that we are able to address key challenges our customers face in developing new therapeutics," explained Dr. Claude Benchimol, Invitrogen's Senior Vice President, Research and Development. "Pharmaceutical companies need to accelerate target identification in their discovery efforts and study off target effects to help reduce failure rates, and now for the first time, there is a tool that rapidly helps them do both."
This first-in-class research tool supports the current shift from genome projects to an emphasis on studying proteins and protein function on a system wide, or proteome, scale. This is particularly important for pharmaceutical firms since proteins make up the majority of therapeutic targets. The ProtoArray is available to both commercial and academic researchers for studying a wide variety of protein interactions including protein-protein, protein-DNA and antibody specificity experiments.
"We have used the ProtoArray to search for components of a signaling pathway that regulates neural development," said Dr. Anthony Koleske at Yale University's Departments of Molecular Biophysics and Biochemistry and Neurobiology. "These high density arrays give us a very sensitive assay to identify pathway components that can not be found using more traditional approaches."
The ProtoArray Human Protein Microarray contains proteins derived almost entirely from Invitrogen's Ultimate(TM) ORF Clone Collection, assuring high-quality content through sequence verification and quality control measures. Additionally, the ProtoArray Human Protein Microarray pulls together key technologies from several important areas of Invitrogen's business including labeling and detection technologies from its Molecular Probes group, cloning technologies from its Functional Genomics business and protein array development capabilities gained through the acquisition of ProtoMetrix, Inc.
"By making high performance, high throughput and user friendly protein analyses widely available and affordable, our ProtoArray technology has the potential to jumpstart the growth of the protein array market, and is an example of Invitrogen's commitment to technology and market leadership," said Gregory T. Lucier, Chairman and CEO of Invitrogen. "ProtoArray is the first-in-class entrant in a market that could mirror the growth of the highly-successful DNA microarray segment. Invitrogen's global distribution reach, outstanding technical service and ability to provide integrated products and services across the entire continuum of research make it the ideal marketer for this breakthrough product."
The world's first commercial proteome array, the Yeast ProtoArray, was introduced by Invitrogen at the BIO 2004 conference in San Francisco in June. Launch of the Yeast ProtoArray and development of the human protein products follows Invitrogen's acquisition of the former Protometrix in Branford, Connecticut and the integration of their breakthrough technologies with Invitrogen's product portfolio and marketing and development capabilities.
For more information on the ProtoArray line of products, please visit ProtoArray Central at www.invitrogen.com/protoarray.
About Invitrogen
Invitrogen Corporation (Nasdaq:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bio-production. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology – placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California and conducts business in more than 70 countries around the world. The company globally employs approximately 4,000 scientists and other professionals. For more information about Invitrogen visit the company's web site at www.invitrogen.com
Threshold Pharmaceuticals Receives FDA Fast-Track Status for Glufosfamide
South San Francisco, CA – November 15, 2004
Threshold Pharmaceuticals Inc. (www.thresholdpharm.com) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to one of the company's lead drug candidates, glufosfamide, for injection to treat unresectable locally advanced or metastatic pancreatic adenocarcinoma previously treated with gemcitabine.
Under the FDA Modernization Act of 1997, the Fast Track drug development program provides for expedited regulatory review for new drugs demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. In addition, the FDA will facilitate and expedite the development and review of the application for the approval of the product.
According to the FDA, glufosfamide was designated as a fast track product both because of the severity of pancreatic cancer and because glufosfamide may provide a therapeutic benefit to the intended patient population. The potential of glufosfamide to provide therapeutic benefit was based on preclinical results and anti-tumor activity (tumor shrinkage) demonstrated in early clinical trials. There are currently no approved therapies for patients with metastatic pancreatic cancer refractory to gemcitabine. These patients have an expected survival of approximately three months.
“Glufosfamide's fast track status underscores the urgency of developing new treatment options for pancreatic cancer patients and the potential of glufosfamide to improve current survival rates for this devastating disease.” said George Tidmarsh, M.D., Ph.D. founder and president of Threshold Pharmaceuticals. “Threshold will continue to work closely with the FDA to expedite the development of Glufosfamide.”
Data from the company's pivotal Phase 3 clinical trial, currently under enrollment in the United States, will be submitted to FDA as part of Threshold's marketing application, should the study meet its primary endpoint. This study, for which Threshold has received a Special Protocol Assessment (SPA) from the FDA, will evaluate the survival of patients treated with Glufosfamide in conjunction with best supportive care (BSC) versus those patients treated with BSC alone.
Previous studies have demonstrated that glufosfamide kills cancer cells and can shrink pancreatic cancers. Data from an initial Phase 1 trial of glufosfamide were published in the Journal of Clinical Oncology (Oct. 2000). This trial determined the maximum tolerated dose of glufosfamide in patients with a variety of solid tumors. The only pancreatic cancer patient enrolled in this Phase 1 trial achieved a complete remission of disease and remained in remission over five years later after receiving glufosfamide treatment alone.
Data from a Phase 2 trial of glufosfamide for the treatment of pancreatic cancer were reported at the 93rd Annual Meeting of the America Association for Cancer Research (AACR), April 6-10, 2002, as well as published in the November 2003 issue of the European Journal of Cancer. The fully enrolled study included 35 chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer. This study was enrolled from February 2000 to March 2001. The data documented objective tumor shrinkage, which was verified by an independent review of radiographs. An updated analysis of the survival data shows an estimated 9% two-year survival, which compares to 1% or less in historical studies with other first-line therapies. Careful monitoring of renal function was required. Hematological toxicity was mild, and the most common adverse effects were grade I nausea and vomiting.
About Pancreatic Cancer
The American Cancer Society estimates that 31,860 patients will be diagnosed with pancreatic cancer in the United States in 2004, and approximately 31,270 patients will die from the disease. Only 15 – 20 percent of newly diagnosed patients are eligible for surgery, which is typically followed by radiation and chemotherapy. Patients with inoperable pancreatic cancer are treated with radiation and chemotherapy, or in the case of advanced disease, chemotherapy alone as the advantages of radiation are reduced. The only currently approved drug for the treatment of pancreatic cancer, Gemzar, has demonstrated median survival of less than six months.
About Threshold Pharmaceuticals
Threshold Pharmaceuticals (www.thresholdpharm.com) is focused on the discovery, development, and commercialization of small molecule therapeutics based on “Metabolic Targeting”. This new 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.
GeneOhm Sciences and The Cleveland Clinic Announce the Completion of a Study on Thrombophilia Markers Using the ePlex Platform
San Diego, CA – (Business Wire) – November 9, 2004
GeneOhm Sciences, Inc. (GSI) today announced the completion of the first collaborative study between GSI and The Cleveland Clinic Foundation. This study focused on several Single Nucleotide Polymorphisms (SNPs) in genes associated with venous thromboembolism (VTE). Using GSI's proprietary ePlex(TM) platform, six markers were simultaneously genotyped in multiplex reactions and compared to results observed on the Roche LightCycler(R). Of 269 single-point genotypes, each platform exhibited 100% concordant results.
The six SNP panel of markers, shown to be risk factors for thrombophilia, consisted of: factor V Leiden (FVL) and HR2A45374G, prothrombin G20210A, MTHFR C677T and A1298C, along with plasminogen activator inhibitor 1 (4G/5G) (PAI1). Each sample in the study was evaluated using the proprietary electrochemical array on the GeneOhm ePlex platform, which enables multiplexed detection. Kandice Marchant, M.D., Ph.D., Director, Hemostasis and Thrombosis Laboratory, Clinical Pathology at The Cleveland Clinic, will present the findings and the clinical correlation of the markers at the Association for Molecular Pathology Annual Meeting on November 10, 2004.
GeneOhm and The Cleveland Clinic, under the direction of Raymond Tubbs, D.O., Department Chairman, Clinical Pathology, will continue to evaluate this and other applications on the ePlex platform. This technology is the basis for robust multiplexed molecular diagnostic applications in inherited diseases, infectious diseases and oncology. GeneOhm will release the first products on the ePlex platform in early 2005.
About GeneOhm Sciences
GeneOhm Sciences is a molecular diagnostic company located in San Diego. The company is applying its integrated proprietary technology portfolio, which includes electrochemistry, sample processing and chip fabrication, to serve the unmet diagnostic needs in a wide range of diseases, including inherited diseases, infectious diseases and oncology. Established in 2001 with technology developed over a decade by Professor Jacqueline K. Barton at the California Institute of Technology, GeneOhm Sciences has attracted a group of leading investors and scientists with years of experience in the life science and electronics fields. Our portfolio is expanding with our merger with Infectio Diagnostic, Inc., a Canadian molecular diagnostic firm specializing in the development of diagnostic products that allow for the rapid detection and identification of a wide variety of infectious agents from human clinical specimens. These products provide a significantly more rapid response to clinicians by comparison with traditional methods, which often require several days. Infectio Diagnostic was formed in 1995 by Professor Michel G. Bergeron of Laval University, Quebec.
GeneOhm Sciences and Infectio Diagnostic Announce Plans to Merge
San Diego, CA & Quebec City, QC – October 21, 2004
GeneOhm Sciences, Inc. (GSI) and Infectio Diagnostic (IDI), Inc. today announced their plans to merge and form a molecular diagnostic company with the technology, intellectual property, leadership and expertise to serve all major areas of molecular diagnostic testing.
"The merger of GSI and IDI brings together a cost-effective platform for multiplexing, a broad portfolio of molecular targets and the capability to develop molecular diagnostic products for infectious diseases. Together, GSI and IDI will create a rich pipeline of products serving the unmet needs in key areas of medical diagnostics," said Peter Klemm, PhD, CEO of GeneOhm Sciences. Dr. Klemm will continue as CEO in the combined company.
"This merger brings the multidetection platform that will apply our broad molecular IP to the needs of infectious disease diagnostics; our combined products will then fulfill the entire needs of our customers," said Jean Pierre Gayral, PhD, President of IDI. Dr. Gayral will be President of the Canadian Organization and Senior Vice President for Infectious Disease in the combined company.
IDI has established itself as a premier provider of molecular diagnostics in infectious diseases with two FDA and Health Canada-cleared assays that provide clinicians with rapid response solutions in two critical areas: one hour detection directly from the clinical specimen of Group B Streptococcus colonization in pregnant women at time of delivery and one hour detection directly from the clinical specimen of Methicillin Resistant Staphylococcus Aureus (MRSA), the most critical antibiotic resistant bacteria. These products are the first to be cleared by Health Canada and the US FDA as meeting the specifications required to replace culture for microorganism detection. The company will continue to supply its proprietary assays on the Cepheid Smart Cycler(R) platform.
GSI has developed its proprietary platform, ePlex(TM), for electrochemical detection of nucleic acids and propriety methods of sample processing. This technology is the basis for multiplexed molecular diagnostic applications in inherited diseases, infectious diseases and oncology. The company will release the first products on the ePlex(TM) platform in early 2005.
Professor Michel G. Bergeron of Laval University, Quebec, and founder of IDI, remarked, "I am enthusiastic about joining with a team that shares my vision for developing molecular diagnostic products with the potential to change the practice of medicine."
Jacqueline K. Barton, PhD, Arthur and Marian Hanisch Professor of Chemistry at Caltech and GSI's founder, said, "The scientific leadership that has been established at IDI represents the kind of partner that affirms my belief that multiplexed molecular diagnostics can be a force for change in the way patients are diagnosed and treated."
The combined company will maintain its facilities in Quebec and in San Diego, creating competence centers that leverage the unique expertise of each organization.
"The merger of GSI and IDI creates a company with unparalleled breadth in the growing molecular diagnostics field," said James Blair, PhD, of Domain Associates, LLC. Ron Lennox, DPhil, of CHL Medical Partners, LLC, and Rick Blume of CB Health Ventures added that, "by creating an organization with strong proprietary positions in innovative technology and molecular content, we are establishing a sustainable leadership position that will continue to grow as more and more applications for molecular diagnostics in human medicine are established." Blair, Lennox and Blume, current investors in GSI, are part of a syndicate of leading venture capital firms that will fund the merger and provide operating capital to support the combined company's initiatives in research, development, sales and marketing.
IDI was financed since its founding by a group of private investors and public funds from Societe generale de financement and Innovatech Quebec , which believe that the transaction will be beneficial to both companies. The new company will benefit from the IDI R&D and manufacturing infrastructure built in Quebec City.
The proposed merger, which is subject to approvals by the shareholders of both companies, the Superior Court of Quebec, appropriate securities authorities, as well as customary closing conditions, is expected to close in November 2004.
About GeneOhm Sciences, Inc.
GeneOhm Sciences is a molecular diagnostic company located in San Diego. The company is applying its integrated proprietary technology portfolio, which includes electrochemistry, sample processing and chip fabrication, to serve the unmet diagnostic needs in a wide range of diseases including inherited diseases, infectious diseases and oncology. Established in 2001 with technology developed over a decade by Professor Jacqueline K. Barton at the California Institute of Technology, GeneOhm Sciences has attracted a group of leading investors and scientists with years of experience in the life science and electronics fields. For more information, visit the company's web site at www.geneohm.com.
About Infectio Diagnostic, Inc.
Infectio Diagnostic is a Canadian biotechnology firm specializing in the development of diagnostic products that allow for the rapid detection and identification of a wide variety of infectious agents from human clinical specimens in less than one hour. These products provide a significantly more rapid response to clinicians by comparison with traditional methods, which often require several days. Infectio Diagnostic was formed in 1995 by Professor Michel G. Bergeron of Laval University, Quebec. For more information, visit the company's web site at www.infectio.com.
Threshold Pharmaceuticals Appoints William A. Halter and George G. C. Parker to Board of Directors
South San Francisco, CA – October 13, 2004
Threshold Pharmaceuticals, Inc. today announced the addition of William A. Halter and George G. C. Parker, Ph.D. to its board of directors.
Mr. Halter has over 20 years of leadership experience in the public and private sectors. Nominated by the President and confirmed by the U.S. Senate, he served as the Deputy Commissioner and Acting Commissioner of Social Security during the Clinton administration, providing leadership to a Cabinet-rank agency comprising one of the largest financial services organizations in the world with 65,000 employees serving more than 50 million beneficiaries. Previously, he was appointed Senior Advisor in the Office of Management and Budget in the Executive Office of the President, where for six years he presented budget options to the President and coordinated the work of the President's Management Council. Prior to this, he was an Economist for the Joint Economic Committee of the United States Congress and Chief Economist for the United States Senate Committee on Finance which has legislative jurisdiction over taxes, health care, Social Security, and international trade.
Mr. Halter is currently a member of the Board of Directors of four public companies in the life sciences and information technology industries (Akamai Technologies, InterMune, webMethods, and Xenogen). He is a Trustee Emeritus of Stanford University, having served on Stanford's Board of Trustees for seven years and chairing its Committee on Academic Policy. Also at Stanford, he is a member of the Humanities and Sciences Council, the National Advisory Council for Stanford Medical School, and the Advisory Council for Stanford University Libraries. He received an A.B. degree with Honors and Distinction in Economics and Political Science from Stanford University in 1983. After being selected as both a Rhodes Scholar and a Marshall Scholar, he received a Master of Philosophy degree in Economics from Oxford University in 1986.
Dr. Parker has over three decades of distinguished academic and board level experience. He joined Stanford University's Graduate School of Business in 1973 and is currently the Dean Witter Professor of Finance and Management. At Stanford, he has held a series of positions, including Senior Associate Dean for Academic Affairs, Director of the MBA Program, Director for Executive Education at the Business School and Director of the Stanford Sloan Program for Executives. In March 2002, the Stanford Graduate School of Business faculty honored him with the Robert T. Davis Award for his extraordinary lifetime contributions to the School.
Dr. Parker is a member of the Board of Directors of Continental Airlines, Inc., California Casualty Group of Insurance Companies, H. Warshow & Sons, Inc., and Converium Reinsurance. He is a past Board member of University National Bank in Palo Alto, California. He graduated from Haverford College, Pennsylvania with a degree in economics in 1960, and received an MBA in finance in 1962 and a Ph.D. in finance in 1967, each from Stanford. He taught at Columbia University and joined a venture capital firm before joining the Stanford faculty in 1973 to teach finance and direct the Sloan Program.
“It's a great privilege to be able to add these two extraordinary individuals to the Threshold board of directors,” said Harold E. “Barry” Selick, Ph.D., Chief Executive Officer of Threshold. “They bring a wealth of experience in finance and the management of successful organizations and will be key advisors as Threshold expands its focus from research and clinical development to commercialization.”
About Threshold Pharmaceuticals
Threshold Pharmaceuticals (www.thresholdpharm.com) is focused on the discovery, development, and commercialization of small molecule therapeutics based on “Metabolic Targeting”. This new 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.
VaxInnate Corporation Receives NIH Funding to Support Toll-like Receptor Ligand Discovery
New Haven, CT – October 8, 2004
VaxInnate Corporation today announced that it has been awarded $5.9 million from the National Institutes of Allergy and Infectious Disease (NIAID/NIH) to support the discovery and development of novel stimulators of the innate immune system.
The innate immune system represents the body's first line of defense against invading pathogenic organisms. Using a restricted set of receptors that identify specific Pathogen-Associated Molecular Patterns (PAMPs), the innate immune system alerts the host to an infectious insult and sets off a cascade of responses that culminates in the activation of specific B- and T-cell responses that can provide life-long protection against re-infection by the same pathogen. This specific response, called the adaptive immune response, is the basis for vaccine activity. Receptors which recognize PAMPs, such as Toll-like receptors (TLRs), are the key link between the innate and adaptive immune responses. Recent evidence demonstrates that fusing a polypeptide ligand specific for a TLR to an antigen of interest generates a vaccine that is more potent and selective than the antigen alone, and eliminates the need for formulating the vaccine in complex adjuvants. VaxInnate is developing a high-throughput screening platform to discover and optimize new TLR ligands, and incorporate those ligands into vaccines for use against infectious diseases that pose a public health and national defense threat.
“VaxInnate is pleased to receive funding from NIAID to support these exciting discovery efforts,” said Jeff Powell, Ph.D., Senior Director of Research and Development for the Company, and Principal Investigator on the funded research programs. “We believe the link between innate and adaptive immunity is critical to the generation of a protective immune response, which is the goal of any vaccine technology. By discovering novel molecular triggers of TLR signaling, and incorporating those triggers into next-generation vaccines, we will generate more potent pathogen- or tumor-specific immunity with greatly reduced unwanted side-affects.”
VaxInnate Corporation is a private biotechnology company focused on exploiting the principles of innate immunity to provide an entirely new technology platform for the development and commercialization of next generation prophylactic vaccines and immune therapies. The Company's VaxIneª technology is a proprietary type of vaccine that contains an antigen coupled with Pathogen-Associated Molecular Patterns (PAMPs). For more information on VaxInnate, please visit www.vaxinnate.com.
VaxInnate Corporation Appoints David Jackson, Vice President of Product Development, and Secures State-of-the-Art Product Development Facility
New Haven, CT – October 8, 2004
VaxInnate Corporation today announced the appointment of David Jackson as Vice President of Manufacturing and Product Development. Mr. Jackson brings over twenty-five years experience in the biopharmaceutical industry that ranges from Head of Manufacturing for Armour Pharmaceutical's Coagulation Products Group to Vice President of Manufacturing for BioReliance. Mr. Jackson has a broad base of experience and expertise in building manufacturing teams and operations including start-up and scale-up of sophisticated processes, day-to-day responsibility for established operating units and a thorough understanding of regulatory agency requirements as well as compliance issues including inspections and submissions.
“Mr. Jackson brings to VaxInnate the experience and know-how that will greatly facilitate the rapid and successful transfer of our technology from the bench to the clinic,” said Dr. Carlo Russo President and CEO.
The Company also announced that it has leased and occupied a facility located at Three Cedar Brook Drive in Cranbury, New Jersey, to house the corporate and Development teams. In addition to corporate office space, the 15,000 square foot facility houses built-out general and specialty laboratory space that is ideally suited for the Company's product development needs.
“We are excited about the expansion and the opportunity this represents for VaxInnate,” said Mr. Jackson. “The selection of this site came about through an exhaustive search for a location that would best fit our needs for accelerated process and drug development initiatives. The qualities of the infrastructure and the layout of the various labs are an excellent fit for our immediate needs as well as providing capacity for growth. With the establishment of our operations here in the Three Cedar Brook facilities we are well positioned to launch our preclinical development efforts and move quickly on to the path to clinical investigations.“
VaxInnate Corporation is a private biotechnology company focused on exploiting the principles of innate immunity to provide an entirely new technology platform for the development and commercialization of next generation prophylactic vaccines and immune therapies. The Company's VaxIneª technology is a proprietary type of vaccine that contains an antigen coupled with Pathogen-Associated Molecular Patterns (PAMPs). For more information on VaxInnate, please visit www.vaxinnate.com.
LuMend Introduces System Solution for Crossing and Re-Entry of Chronic Total Occlusions in the Peripheral Vasculature; Company Launches Outback(R) Re-Entry Catheter in Rapidly Growing Peripheral Vascular Market
Redwood City, CA – (Business Wire) – October 7, 2004
LuMend Inc., a leader and innovator in developing catheter-based technology for crossing chronic total occlusions (CTOs), reported today that it has launched the Outback(R) Re-Entry Catheter. The company's proven peripheral crossing technology, the Frontrunner(R) XP CTO Catheter, now combines with the Outback Catheter to provide the first system solution that addresses the two major challenges associated with facilitating treatment of CTOs in peripheral arteries: lesion crossing and sub-intimal re-entry.
CTOs are among the most common reasons patients with vascular disease are referred to surgery or bypass grafting rather than less invasive catheter-based procedures. In order to treat a CTO patient with minimally invasive therapy, a physician must first successfully cross the blockage and place a guidewire in the "true" lumen of the artery beyond the occlusion. Because some CTOs are comprised of hard, rock-like plaque, it can be very difficult for the physician to cross the blockage. As a result, it is not uncommon for the crossing device to be diverted outside of the true lumen and into the "false" lumen of the artery. The process of re-entering the true lumen can be arduous and extremely time consuming. The Outback Re-Entry Catheter is designed to provide a simple and safe re-entry process that quickly redirects a guidewire from the false lumen back into the true lumen of the artery. Once this is achieved, the interventional procedure can continue.
If the physician is unable to deliver the guidewire back into the true lumen past the CTO, the procedure is stopped and alternative treatment options are then considered, such as peripheral bypass surgery. If surgery is not a viable option or is deemed too risky, patients may be forced to live with their symptoms, which can include leg pain, inability to walk, sores and infections that won't heal and other life-style limiting issues. In the most severe cases, untreated CTOs can also lead to limb loss.
Dr. Mark W. Mewissen, MD, Director of St. Luke's Vascular Center in Milwaukee, Wisconsin, reported his initial experience with the Outback Re-Entry Catheter in an issue of Endovascular Today earlier this year.
"Technical success of a percutaneous endovascular procedure is predicated on the successful placement of a guidewire in the true lumen beyond the lesion," he explained. "Unpredictable sub-intimal passage of a guidewire requires the endovascular specialist to successfully re-enter the true lumen of the artery to treat the occlusion. At times, this re-entry process can be technically challenging as well as time and resource consuming." He added, "Gaining rapid and reproducible true lumen access beyond the lesion is one of the keys in achieving high procedural success rates, especially in long femoral popliteal arterial blockages. The Outback Re-Entry Catheter has proven to be an extremely effective, simple and safe device for predictable re-entry into the true lumen of the artery. This advancement in technology should broaden the opportunity to successfully treat patients with peripheral occlusive disease who traditionally are not considered candidates for percutaneous, less invasive catheter interventions."
"The Outback Re-Entry Catheter represents an outgrowth of the new direction we identified for our corporate strategy," stated Phil Hopper, President and CEO of LuMend. "By creating a pathway of re-entry to the true lumen, LuMend has given physicians the ability to consider catheter-based treatment options for an expanded set of patients suffering from debilitating peripheral vascular conditions. The combination of the Outback Re-Entry Catheter and our Frontrunner XP Peripheral Catheter, results in a complete system solution designed to enable the delivery of a broad spectrum of catheter-based therapy choices."
About LuMend
LuMend, Inc. was co-founded by pioneering interventional cardiologists, John Simpson, MD, PhD, and Matt Selmon, MD in 1996 to provide a clinical solution to chronic total occlusions. While the company's initial focus was in the coronary vascular system, LuMend modified its strategic direction to include developing product platforms that target chronic total occlusions in the rapidly growing peripheral vascular market in early 2004.
The company is now focused on delivering technology and services to interventional cardiologists, radiologists and vascular surgeons specializing in endovascular techniques for the treatment of peripheral vascular disease.
Zoll Exercising Option to Acquire Revivant Corporation
Chelmsford, MA – October 5, 2004
ZOLL Medical Corporation (NASDAQ: ZOLL), a manufacturer of resuscitation devices and software solutions, today announced that it is exercising its option to acquire Revivant Corporation of Sunnyvale, California, the manufacturer of the AutoPulse™ Non-invasive Cardiac Support Pump. The AutoPulse is an FDA-approved device that offers the potential of restoring near-normal blood flow levels in victims of Sudden Cardiac Arrest (SCA). Many clinicians who have used the AutoPulse call it the single most important development in the treatment of SCA in the past 30 years.
ZOLL anticipates that it will complete the acquisition of Revivant in accordance with the Merger Agreement. Once completed, Revivant will become a subsidiary of ZOLL and retain its manufacturing and R&D functions in Sunnyvale . ZOLL will consolidate marketing and sales operations at its headquarters in Chelmsford , Massachusetts and ZOLL will retain the AutoPulse product name for marketing purposes.
This option was part of an agreement announced in August 2003, through which ZOLL invested $7 million in Revivant preferred stock and provided $5 million of debt financing. ZOLL received a 15% stake in Revivant and the option to acquire their remaining outstanding shares.
Upon completion of the acquisition, ZOLL will pay an additional $15 million as the initial merger payment. ZOLL will also make clinical milestone payments, targeted at $15 million, tied to the completion of certain clinical trials with the AutoPulse through 2006. ZOLL will make additional payments for the years 2005 through 2007 based on the growth of AutoPulse sales. In general, all payments will be a combination of cash and ZOLL common stock.
Commenting on the transaction, Richard A. Packer, President and Chief Executive Officer of ZOLL, said, “We believe the AutoPulse will cause a major sea change in how resuscitation is performed, and is the most important advance since the introduction of external defibrillation. This acquisition presents an exciting opportunity to expand our presence in the resuscitation market and positions us well for additional growth. We feel there is potential for incremental revenue of $13 to $15 million during the ramp-up phase in fiscal 2005, potential for $30 million or more in fiscal 2006, with even greater promise for fiscal 2007 and beyond. The AutoPulse offers the potential of significant incremental growth in the coming years. We believe that the market for this product eventually has the potential to be equivalent to the worldwide professional defibrillator market, which is estimated at $650 million.”
In only its first year of commercial availability, more than 80 customers have already purchased the AutoPulse and have been actively using it as part of their resuscitation protocol. It is a technology that significantly advances the way resuscitation is performed in pre-hospital and hospital settings. “I've been a paramedic for more than 20 years, and I've never seen a device that does what the AutoPulse does,” said Mike Poniatowski, Director of Operations for EVAC Ambulance Service in Daytona Beach, Florida . “Everything we do right now is based on our two hands and manual CPR. But with circulatory rates and the perfusion that the AutoPulse delivers, we will change everything we do when treating cardiac arrest patients. We will rewrite the book on resuscitation.”
The automated, portable AutoPulse is a battery-operated electromechanical platform with a disposable band that fastens across a victim's chest. The AutoPulse compresses the entire chest in a consistent, optimal “hands-free” manner, moving much more blood than manual chest compressions. Additionally, it offers the benefit of freeing up rescuers to focus on other life-saving interventions.
The effectiveness of the AutoPulse is evidenced by the results of three significant research studies that have been published in major peer-reviewed journals:
• An animal hemodynamics study conducted by Halperin et al. at Johns Hopkins University demonstrated that the AutoPulse generated pre-arrest levels of blood flow to the heart and brain.
• A human hemodynamics study completed by Timmerman et al. showed that the AutoPulse generated 33% greater coronary perfusion pressure (CPP) than manual CPR conducted by medical residents. The American Heart Association has called CPP an important measurement of blood flow to the heart.
• An animal survival study conducted at Stanford University by Ikeno et al. resulted in 73% of subjects supported with the AutoPulse returning to normal blood flow and surviving, with 88% of the survivors determined to be neurologically normal. None of the subjects supported with conventional CPR survived.
Mr. Packer concluded, “Our vision of advancing resuscitation is coming together. We are excited about our future growth prospects, not only in the defibrillator business, but also with emerging technologies, such as the AutoPulse. We believe that ZOLL has built the sales and distribution strength to create tremendous leverage over the long term as we continue to broaden our product portfolio. In addition to expanding our product line, ZOLL believes that the integration of these technologies over time will bring new levels of efficiency and efficacy to resuscitation efforts worldwide.”
About ZOLL Medical Corporation
ZOLL Medical Corporation (NASDAQ: ZOLL) designs, manufactures, markets, and/or sells non-invasive resuscitation devices and software solutions. They include pacing and defibrillation devices (ZOLL's M Series™ and AED Plus™, and LIFECOR, Inc.'s LifeVest™ and Life-Padz™ WCD 3000S Wearable Defibrillators), circulatory assist devices (the AutoPulse™ and Advanced Circulatory Systems, Inc.'s ResQPOD® Circulatory Enhancer); and a fluid resuscitation product called the Power Infuser™, manufactured by Infusion Dynamics, a division of ZOLL. These devices help healthcare professionals, emergency medical service providers, and first responders diagnose and treat Sudden Cardiac Arrest and trauma victims.
Additionally, through its subsidiary ZOLL Data Systems, ZOLL designs and markets software that automates the collection and management of both clinical and non-clinical data. With direct operations, international offices, and business partners in all of the world's major markets, ZOLL markets and sells its products in more than 140 countries. For more information, visit www.zoll.com or call +1 (978) 421-9655.
Cellular Genomics Appoints Dr. Udo Klein Senior Vice President of Drug Development
Branford, CT – October 4, 2004
Cellular Genomics Inc. (CGI), a chemical genetics based drug discovery and development company, today announced that Udo Klein, Ph.D. has joined the Company in the newly created position of Senior Vice President of Drug Development, reporting to Louis A. Matis, M.D., President and Chief Executive Officer. Dr. Klein was formerly Senior Vice President, Research & Development at EntreMed.
"We are excited to have Udo join CGI, as he brings to the Company broad expertise and a strong track record in advancing drug discovery programs into clinical development," said Dr. Matis. "His extensive drug development experience and, in particular, his strength in oncology will prove to be major assets as we progress our novel therapeutic programs in anti-angiogenesis and cancer, as well as autoimmune and inflammatory diseases."
Dr. Klein, 52, has more than two decades of broad-based pharmaceutical experience, having participated in the development of a variety of therapeutic compounds from discovery to product launch. While at EntreMed, Dr. Klein led the Company's small molecule therapeutics research and development effort and was responsible for advancing the Company's pipeline, in particular EntreMed's lead clinical candidate, Panzem(R). Prior to joining EntreMed in October 2003, Dr. Klein was with Bayer Corporation for 23 years, holding numerous senior-level management positions with the Pharmaceutical Division. Most recently as Global Project Leader for Oncology and Director of Global Project Management for Oncology, Dr. Klein was responsible for the development of a number of oncology drugs, including a signal transduction inhibitor (currently in phase III clinical development) and a novel taxane. From 1996 to 1999, Dr. Klein managed the worldwide development of several Bayer diabetes drugs as the Director of International Project Management for Metabolics. Between 1993 and 1996, Dr. Klein served as Vice President for Technical Operations and Site Manager at Bayer's California facility where he was responsible for the production of Kogenate(R). From 1991 to 1993, Dr. Klein was Head of Regulatory Affairs International with Bayer AG Pharmaceutical Business Group in Germany and previously served as Project Director and Research Scientist at Bayer's Miles Inc./Cutter Biological in California. During the first six years of his industry career, Dr. Klein was a Head of Laboratory with Bayer AG in Germany. Dr. Klein earned his Ph.D in biochemistry from the University of Muenster in Germany.
"I am very pleased to be joining CGI at this exciting point in the Company's development," said Dr. Klein. "CGI's proprietary technologies, drug discovery capabilities, and growing pipeline of product candidates are highly promising and I look forward to applying my skills to lead CGI's drug development programs. I am quite impressed with CGI's progress to date and look forward to working with the entire team as the Company advances its compounds into the clinic."
About CGI
Cellular Genomics Inc. (CGI) is a privately held genomics-based biopharmaceutical company that is pioneering a unique, highly integrated chemical genetics platform (Analog Sensitive Kinase Allele, or ASKA, technology) to discover and develop kinase and other signal transduction 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 three drug discovery and development programs in autoimmune and inflammatory disease, cancer, and angiogenesis that are advancing rapidly toward 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.
POINT Biomedical Corporation to Present at UBS Global Life Sciences Conference
San Carlos, CA – (BUSINESS WIRE) – September 27, 2004
POINT Biomedical Corp. announced today that Jerry Griffin, M.D., President and Chief Executive Officer of POINT will make a presentation describing the progress of the company at the UBS Global Life Sciences Conference in New York City at 1:00 EST on Wednesday, September 29, 2004. Dr. Griffin's presentation will be broadcast on the web. The webcast for Dr. Griffin's presentation can be found on POINT's website, www.Pointbio.com or by going directly to http://event.streamx.us/event/default.asp?event=ubs20040927.
About POINT Biomedical
POINT Biomedical is developing novel technology platforms for imaging and drug delivery applications. The lead product, CARDIOsphere® (PB127), is an ultrasound-imaging agent for assessing myocardial perfusion, and has completed Phase 3 clinical testing in the United States. If approved for marketing in the U.S. by the Food and Drug Administration, CARDIOsphere could allow a cardiologist to determine the state of a patient's coronary artery circulation in the office setting, without the use of radioactive isotopes.
QIAGEN Acquires Key Assets of Molecular Staging, Inc.; Accretive Transaction - Technology Solves Limitations Due to Scarce Samples
Venlo, The Netherlands and New Haven, CT – September 27, 2004
QIAGEN N.V. (Nasdaq: QGENF; Frankfurt, Prime Standard: QIA) today announced that it has completed the acquisition of the key assets of Molecular Staging, Inc. (MSI). MSI, a privately held company, has developed a range of proprietary products and services based on its Multiple Displacement Amplification (MDA) technology. The key application of MDA is whole genome amplification (WGA) which is designed to eliminate limitations created by the scarce quantities of DNA samples available for customers to perform an increasing number of analyses. MSI's products and services are primarily targeted at QIAGEN's current customer base and are a natural complement to QIAGEN's current product range. The technology portfolio acquired from MSI adds a new dimension of customer benefit and is in QIAGEN's core focus on pre-analytical solutions. QIAGEN believes that this transaction further expands its position as the market and technology leader in nucleic acid handling, separation and purification in the industrial and academic research, and molecular diagnostics markets.
Under the terms of the acquisition agreement, QIAGEN has acquired the major assets of MSI (which include over 160 applied or issued patents) for US$28.5 million in cash plus potential earn-outs of up to US$6.75 million. QIAGEN expects to incur one-time charges relating to the acquisition of approximately US$2 million in the third quarter 2004. Based on preliminary analysis, QIAGEN expects this transaction to have a positive and slightly accretive impact on QIAGEN's 2005 net income per share and revenue growth - adding approximately US$6 million in Net Sales and approximately US$1 million in Net Income in 2005. QIAGEN expects products derived from this transaction to generate very rapid growth in Net Sales and Operating Income in the following years.
The challenge of having insufficient quantities of DNA for analysis, frequently known as DNA Constraint, is a significant limitation for a growing number of customers worldwide. The importance of this limitation is increasing due to: 1) the rapidly increasing number of DNA analyses and 2) the use of DNA source material which is limited in quantity.
The problems associated with DNA Constraint have been particularly fueled by the increasing trend towards analyzing greater numbers of clinical patient samples. In many cases the amount of available DNA source material is limited. Patient samples collected in biobanks or in clinical trials are limited in quantity and re-collecting the sample from the same donor at some later time is often not feasible or could result in different DNA content. Collection techniques such as small needle biopsies and less invasive sample collection methods such as buccal swabs, also limit the amount of sample taken originally. In addition, even larger amounts of genomic DNA are being required for the increasing number of analyses that are currently being conducted, such as patient genotyping and to enable the sharing of patient DNA samples between researchers at different locations.
QIAGEN expects that the technology portfolio acquired from MSI will provide a solution to the limitations of scarce DNA samples. Following QIAGEN-based nucleic acid purification, whole genome amplification (WGA) provides precise, complete and unlimited copies of the entire genome and thereby creates a sufficient quantity of DNA from even the smallest amounts of starting material to enable a practically unlimited number of analyses. Performing WGA is therefore often described as “immortalizing” the sample. QIAGEN believes that the opportunities for the WGA technology it acquired from MSI are broad, reaching from general research to sample storage facilities and into diagnostics.
WGA is distinct from PCR since it allows non-specific amplification of the complete genome to create more DNA for analyses, whereas PCR amplifies only specific, mostly very short stretches of DNA matching a predefined target sequence and is designed to detect specific sequences. The two technologies, WGA and PCR, are therefore often synergistic as samples can be pretreated with WGA to create sufficient sample amount for many subsequent analyses using PCR and other downstream applications.
QIAGEN intends to launch a series of kits integrating MSI's WGA technology to address specific customer needs in early 2005. MSI's WGA activities will be integrated into QIAGEN's operations in Germantown , Maryland and Hilden , Germany .
Under the terms of the acquisition, QIAGEN also acquired MSI's technology portfolio related to rolling circle amplification (RCA) which includes the exclusive rights to use this technology for protein applications. QIAGEN expects that products arising from this technology can target applications for both nucleic acids and proteins.
”This accretive acquisition adds a unique and highly synergistic technology position to QIAGEN. We believe that following this transaction, QIAGEN will be the clear technology and market leader for whole genome amplification and is thereby adding a new and valuable dimension of customer benefit for pre-analytical processing between sample collection and analysis. We expect that the technologies acquired will provide solutions for rapidly emerging needs in fast-growing segments of our core markets and integrate well with QIAGEN´s unparalleled and broad product portfolio for nucleic acid sample handling, separation and purification. It is a terrific fit for us, as we are addressing the same customers, with comparable product formats and are leveraging the core strengths of our focused sales force,'' said Peer M. Schatz, QIAGEN's Chief Executive Officer. “We are very impressed by this proven technology and how it can eliminate the limitations resulting from sample scarcity. The need for such solutions has rapidly increased in target markets such as functional studies and clinical trials which are showing significant and long-term growth. We are excited about our potential to create value from this acquisition - it adds a technology portfolio to QIAGEN in pre-analytical solutions - an area where we have paralleled innovation and marketing power.
“As a leader in the field of nucleic handling and preparation, QIAGEN is the ideal platform for the further development of our technology portfolio”, said Richard Barker, MSI's Chairman. “We have seen great enthusiasm from the market for our WGA products and have confidence that QIAGEN will be able to build upon this and further develop the technology to ensure that it remains the leader in the exciting and dynamic market where DNA is a scarce and valuable asset.”
Detailed information on this acquisition will be presented in a Company's conference call today, September 27, 2004 at 9:30am EDT . The corresponding presentation slides will be available 60 minutes ahead of the conference call on the Company's website at www.qiagen.com/goto/092704. A webcast of the conference call will be available on the same website at www.qiagen.com/goto/092704.
Gargoyle Partners LLP acted as exclusive financial adviser to QIAGEN in this transaction.
Molecular Staging, Inc. was established in 1998. Further information on MSI can be found at www.molecularstaging.com.
About QIAGEN:
QIAGEN N.V., a Netherlands holding company with subsidiaries in Germany, the United States, Japan, the United Kingdom, Switzerland, France, Italy, Australia, Norway, Austria, Canada, and the Netherlands believes it is the world's leading provider of innovative enabling technologies and products for the separation, purification and handling of nucleic acids. QIAGEN has developed a comprehensive portfolio of more than 320 proprietary, consumable products for nucleic acid separation, purification and handling, nucleic acid amplification, as well as automated instrumentation, synthetic nucleic acid products and related services. QIAGEN's products are sold in more than 42 countries throughout the world to academic research markets and to leading pharmaceutical and biotechnology companies. In addition, QIAGEN is positioning its products for sale into developing commercial markets, including DNA sequencing and genomics, nucleic acid-based molecular diagnostics, and genetic vaccination and gene therapy. QIAGEN employs approximately 1,400 people worldwide. Further information on QIAGEN can be found at www.qiagen.com.
Threshold Pharmaceuticals Begins Enrollment in Phase 3 Pancreatic Cancer Clinical Trial for Glufosfamide—Company Reaches Special Protocol Assessment (SPA) Agreement with FDA
South San Francisco, CA – September 13, 2004
Threshold Pharmaceuticals Inc. (www.thresholdpharm.com) announced today that it has received a Special Protocol Assessment (SPA) from the FDA for a pivotal Phase 3 clinical trial to evaluate Glufosfamide in patients with metastatic pancreatic cancer refractory to first-line treatment. The Company has initiated patient enrollment in the United States.
The SPA agreement indicates that if the trial successfully meets its primary endpoint, the data will provide support for an efficacy claim in a marketing application to the FDA. The primary endpoint will compare the median survival of patients treated with Glufosfamide and ‘best supportive care' (BSC) to those receiving BSC alone. Currently, there are no approved therapies for patients with metastatic pancreatic cancer refractory to first-line treatment. These patients have an expected survival of approximately three months.
“Glufosfamide is the first product from Threshold's pipeline to enter a pivotal Phase 3 trial, which marks a major milestone in our efforts to obtain regulatory approval,” said George Tidmarsh, M.D., Ph.D. and president of Threshold Pharmaceuticals. “This brings us one step closer to potentially offering a new treatment for a devastating disease.”
The SPA is a process that allows for official FDA evaluation of the proposed design of a Phase 3 clinical trial. It provides trial sponsors with an agreement on trial design and analysis required to support a license application submission, if the study is performed according to the SPA.
Study Details
The Phase 3 study will be a randomized, multi-center, multinational trial involving approximately 306 patients to evaluate the safety and effectiveness of Glufosfamide. Eligible patients will be randomized to receive Glufosfamide every three weeks in addition to BSC or BSC alone. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.
Glufosfamide Phase 1 and 2 Data in Pancreatic Cancer
Previous studies have demonstrated that Glufosfamide kills cancer cells and can shrink pancreatic cancers. Data from an initial Phase 1 trial of Glufosfamide were published in the Journal of Clinical Oncology (Oct. 2000). This trial determined the maximum tolerated dose of Glufosfamide in patients with a variety of solid tumors. The only pancreatic cancer patient enrolled in this Phase I trial achieved a complete remission of disease and remained in remission over five years later after receiving Glufosfamide treatment alone.
Data from a Phase 2 trial of Glufosfamide for the treatment of pancreatic cancer were reported at the 93rd Annual Meeting of the America Association for Cancer Research (AACR), April 6-10, 2002, as well as published in the November 2003 issue of the European Journal of Cancer. The fully enrolled study included 35 chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer. This study was enrolled from February 2000 to March 2001. The data documented objective tumor shrinkage, which was verified by an independent review of radiographs. An updated analysis of the survival shows an estimated 9% two-year survival, which compares to 1% or less in historical studies with other first-line therapies. Careful monitoring of renal function was required. Hematological toxicity was mild, and the most common adverse effects were grade I nausea and vomiting.
About Pancreatic Cancer
The American Cancer Society estimates that 31,860 patients will be diagnosed with pancreatic cancer in the United States in 2004, and approximately 31,270 patients will die from the disease. Only 15-20% of newly diagnosed patients are eligible for surgery, which is typically followed by radiation and chemotherapy. Patients with inoperable pancreatic cancer are treated with radiation and chemotherapy, or in the case of advanced disease, chemotherapy alone as the advantages of radiation are reduced. The only currently approved drug for the treatment of pancreatic cancer has demonstrated median survival of less than six months.
About Threshold Pharmaceuticals
Threshold Pharmaceuticals (www.thresholdpharm.com) is focused on the discovery, development, and commercialization of small molecule therapeutics based on “Metabolic Targeting”. This new 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.
POINT Biomedical Corporation Announces New Patent for Unique Microsphere Technology
San Carlos, CA – (BUSINESS WIRE) – August 26, 2004
POINT Biomedical Corp. announced today the issuance of U.S. Patent No. 6,776,761 that further expands its microsphere technology patent portfolio. The patent covers a specific method of enhancing the diagnostic use of ultrasound by providing a microsphere imaging agent having controlled fragility. This property allows for control over where and when the microspheres become active. Microspheres using POINT's controlled fragility technology are designed to remain stable and inactive until exposed to ultrasound energy greater than a predetermined threshold. When this threshold is exceeded, all microspheres in the region to be imaged instantly release their nitrogen gas core producing an intense ultrasound signal. Controlled fragility enhances microsphere performance in a number of applications including ultrasound based molecular imaging and drug delivery. However, it is particularly important for tissue perfusion imaging where uniform breakage and clearance provides a superior image.
“Our lead product, CARDIOsphere® was specifically designed for the detection of myocardial perfusion defects by combining controlled fragility with our patented biSphere® construct”, stated Tom Ottoboni, head of POINT Biomedical Research & Development. Phase 3 trials have been completed and POINT is preparing the NDA submission. The target application for CARDIOsphere is detection of obstructive coronary artery disease by ultrasonic assessment of myocardial perfusion.
More than 12 million Americans suffer from coronary artery disease and an even larger number of individuals have risk factors or symptoms that make them potential candidates for coronary artery disease assessment by non-invasive means. The number of non-invasive imaging studies for diagnosing coronary artery disease in the US is approximately 10 million per year. If approved for the assessment of myocardial perfusion, CARDIOsphere will allow cardiologists to diagnose coronary artery disease in the office or hospital using standard ultrasound equipment and without the use of radioactive isotopes as required by conventional nuclear imaging tests.
“This is POINT Biomedical's fourth major U.S. patent on the biSphere technology platform. It further protects our competitive position and illustrates the depth of our intellectual property portfolio”, commented POINT CEO Dr. Jerry Griffin.
About POINT Biomedical Corp
POINT Biomedical Corp., based in San Carlos, CA is an emerging pharmaceutical company. The Company discovers and develops novel products for diagnostic, molecular imaging and drug delivery applications based on its patented biSphere technology. For additional information, please visit the POINT Biomedical website at www.pointbiomedical.com.
The matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of
Wachovia Capital Partners Invests $20 Million in American Renal Associates and Offers an Additional $10 Million in Growth Capital; Fast Growing Kidney Dialysis Services Positioned for Long Term Success
Charlotte, NC – August 26, 2004
Wachovia Capital Partners today announced the consummation of a $20 million equity investment in American Renal Associates (“ARA”) and the availability of up to an additional $10 million in growth capital for the Company. Wachovia Capital Partners, the principal investing group of Wachovia Corporation, is a leading private equity group that has invested over $2.8 billion since its inception in 1988 and has over $800 million of direct investments under management.
Founded in 1999, ARA develops, owns and operates outpatient kidney dialysis facilities in partnership with nephrologists throughout the United States. ARA is now the sixth largest provider of outpatient kidney dialysis services in the nation with 32 current operating facilities and 14 other de-novo sites under development in 10 states and the District of Columbia. ARA is a service-focused organization that offers physicians and their patients the capabilities and services of a large organization with the responsiveness of an entrepreneurial, professionally managed company.
“We are proud of our accomplishments at ARA and are very pleased to announce this investment and our partnership with Wachovia Capital Partners. Wachovia Capital Partners has considerable dialysis industry experience and extensive financial resources to strongly support the continued growth of ARA,” said Chris Ford, Chief Executive Officer of ARA.
The Company is headquartered in Danvers, Massachusetts and was founded by the senior management team consisting of Christopher T. Ford, Joseph A. Carlucci, Syed T. Kamal and Howard L. Bilow. This team, together with the Company's Chief Financial Officer, John J. McDonough, has over 100 years of collective dialysis operations and management experience.
“We are excited about the investment in ARA due to its experienced management team, proven track record of establishing successful partnerships with physicians, solid platform of existing operations and extraordinary growth prospects. We are delighted to serve as ARA's financial partner and look forward to working together to build upon the Company's impressive accomplishments,” said Neal Morrison, Partner of Wachovia Capital Partners, who will join ARA's Board of Directors.
About American Renal Associates
American Renal Associates is a leading developer, owner and operator of outpatient kidney dialysis facilities in partnership with nephrologists throughout the United States. The Company is the sixth largest provider of outpatient kidney dialysis services in the nation with 32 current operating facilities and 14 other de-novo sites under development in 10 states and the District of Columbia. For more information, visit www.americanrenal.com.
About Wachovia Capital Partners
Wachovia Capital Partners is the private equity and mezzanine investing practice of Wachovia Corporation, the nation's fourth largest bank holding company with over $400 billion of total assets. Wachovia Capital Partners has invested over $2.8 billion since its inception in 1988 and currently manages in excess of $800 million of direct investments. The group targets equity and mezzanine investments of $10 to $50 million in the following sectors: energy, financial services, growth industrial and business services, healthcare, and media and communications. For more information, visit www.wachoviacapitalpartners.com.
About Wachovia Corporation
Wachovia Corporation (NYSE:WB) is one of the largest providers of financial services to retail, brokerage and corporate customers throughout the East Coast and the nation, with assets of $418.4 billion, market capitalization of $58.3 billion and stockholders' equity of $32.6 billion at June 30, 2004. Its four core businesses, the General Bank, Capital Management, Wealth Management, and the Corporate and Investment Bank, serve 12 million client relationships (including households and businesses), primarily in 11 East Coast states and Washington, D.C. Its full-service retail brokerage firm, Wachovia Securities, LLC, serves clients in 49 states. Global services are provided through 32 international offices. Online banking and brokerage products and services also are available through wachovia.com.
POINT Biomedical Corp. Raises $27.1 Million in Equity Financing
San Carlos, CA – (BUSINESS WIRE) – August 19, 2004
POINT Biomedical Corp. announced today that it has raised $27.1 million by a private equity financing. The company will use the proceeds to file a New Drug Application (NDA) with the U.S. Food and Drug Administration for its lead product, CARDIOsphere® (PBC127), an ultrasound imaging agent for the assessment of myocardial perfusion in patients with coronary artery disease, and to retire debt related to construction of its commercial manufacturing facility.
In March 2004, POINT announced that CARDIOsphere had completed Phase 3 clinical testing. The Phase 3 trials were designed to evaluate the performance of CARDIOsphere imaging relative to radionuclide imaging for detecting obstructive coronary artery disease and identifying the anatomic location of perfusion defects.
More than 13 million Americans suffer from coronary artery disease and an even larger number of individuals have risk factors or symptoms that make them potential candidates for coronary artery disease assessment by non-invasive means. The number of non-invasive imaging studies for diagnosing coronary artery disease in the U.S. is over 10 million per year. If approved for the assessment of myocardial perfusion, CARDIOsphere will allow cardiologists to diagnose coronary artery disease in the office or hospital using standard ultrasound equipment and without the use of radioactive isotopes.
Commercial scale manufacturing of CARDIOsphere will be performed in the company's 10,000 square foot pharmaceutical manufacturing site in San Carlos, California. POINT completed construction of the $3 million facility in 2003 and is currently preparing the facility for pre-approval inspection. CARDIOsphere is based on POINT's proprietary biSphere® platform technology, that has a highly scalable and efficient manufacturing process.
Jerry Griffin, M.D., President and Chief Executive Officer of POINT, said "This financing will enable POINT to proceed with the submission of our NDA for CARDIOsphere and to make final preparations for commercial scale manufacturing. I am very pleased at the breadth of support from our investors in this financing."
Investors in the private equity financing included Anvers L.P., CHL Medical Partners, De Novo Ventures, Frazier Healthcare, Fininvest, Institutional Venture Partners, INVESCO Private Capital, Mosaix Ventures, Oakwood Medical Investors, Palo Alto Investors, S.R. One, Limited, The Sprout Group, and William Blair Capital Partners.
About POINT Biomedical
POINT Biomedical is developing novel technology platforms for imaging and drug delivery applications. The lead product, CARDIOsphere, is an ultrasound-imaging agent for assessing myocardial perfusion, has completed Phase 3 clinical testing in the United States. If approved for marketing in the U.S. by the Food and Drug Administration, CARDIOsphere could allow a cardiologist to determine the state of a patient's coronary artery circulation in the office setting, without the use of radioactive isotopes.
The matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory approvals, results of product development programs, and clinical efficacy of and market demand for products, among other matters, may differ significantly from the discussion of such matters in the forward-looking statements.
Amicus Therapeutics Initiates Phase I Trial with Lead Compound AT1001 for the Treatment of Fabry Disease
New Brunswick, NJ – August 5, 2004
Amicus Therapeutics, Inc., an emerging drug development company focused on the development of a novel therapeutic approach to the treatment of human genetic disorders, with an initial focus on lysosomal storage diseases, today announced that it has initiated a Phase I clinical trial with its first clinical candidate, AT1001, for the treatment of Fabry disease.
"Fabry disease is a lysosomal storage disorder caused by a deficiency of alpha-galactosidase A, an enzyme involved in the biodegradation of glycolipids. This is a chronic genetic condition that is responsible for a host of serious ailments, including severe pain, heart disease, and kidney failure,” said David Palling, Ph.D., Vice President of Pre-Clinical Development of Amicus Therapeutics, Inc. “AT1001 is designed to be an orally active, small molecule drug that aims to enhance alpha-galactosidase A activity in patients suffering from Fabry disease, and could provide a novel treatment that is more convenient to use, and is potentially better suited for long-term administration, compared with current therapies.”
Amicus received orphan drug designation from the U.S. Food & Drug Administration for AT1001 in March, 2004.
The Phase I trial will enroll healthy volunteers in a dose-escalating study designed to evaluate the safety and pharmacokinetics of AT1001. In pre-clinical studies, AT1001 was shown to have activity consistent with the pharmacological chaperone mechanism of action, excellent oral bioavailability and favorable toxicological and pharmacokinetic profiles.
“This has been a very eventful and productive year for Amicus. The start of this clinical trial is another significant milestone and marks our transition into a product development company,” said Norman Hardman, Ph.D., Chief Executive Officer of Amicus Therapeutics, Inc. “The completion of our $31 million Series B fundraising in May has provided sufficient financial resources to advance this first product a considerable way through clinical development and to progress our earlier stage pipeline as well. We are very much looking forward to seeing the results of the initial clinical studies with AT1001, as well as advancing the pre-clinical development of additional product candidates that address other serious lysosomal storage disorders, such as Gaucher disease, and other genetic diseases.”
About Fabry Disease
Fabry disease is a lysosomal storage disease caused by a deficiency of alpha-galactosidase A. Patients with classic Fabry disease, of which there are approximately 5,000 people worldwide, have early-onset symptoms, including neuropathic pain, heart disease and kidney disease. Late-onset Fabry disease is characterized by heart and renal involvement in patients who first present to the clinic later in life, typically in early middle-age. Fabrazyme (marketed by Genzyme Corporation) and Replagal (marketed by Transkaryotic Therapies, Inc.) are enzyme replacement therapies that aim to replace the alpha-galactosidase A enzyme that is diminished or absent in Fabry patients. In contrast, AT1001 is designed to provide a small molecule, oral therapy to enhance the patient's own alpha-galactosidase A activity.
About Amicus Therapeutics
Founded in April 2002, Amicus is focused on the development of orally-active, small molecule drugs capable of restoring normal function to mutant proteins. Amicus was founded to capitalize on the discovery that many diseases of genetic origin are caused by missense mutations and other rescuable mutations that result in the misfolding of a protein or enzyme. These misfolded mutant proteins become targeted for degradation before reaching their normal site of action, leading to the disease phenotype.Pharmacological Chaperones are designed to help the mutant protein fold correctly into its normal 3-dimensional conformation, restoring the normal processing and transport of the protein and rescuing its intrinsic biological activity and function.
Amicus technology is based on research conducted by Jian-Qiang Fan, Ph.D., Assistant Professor, Department of Human Genetics at Mount Sinai School of Medicine, and a founder of Amicus. Amicus' pharmacological chaperone approach has the potential to be applied to a wide range of genetic disorders. The Company's initial focus is on lysosomal storage disorders and its first compound, AT1001 for Fabry disease, is in Phase I clinical trials. Amicus currently has 11 employees and is headquartered at the New Jersey Technology Center in North Brunswick, New Jersey. Additional information about the Company can be found at www.amicustherapeutics.com
Protein Polymer and Spine Wave to Begin Negotiations on Terms for Commercial Manufacturing of Spinal Disc Repair Product Spine Wave Receives Approval in Europe to Begin Clinical Testing of NuCore(TM) Injectable Disc Nucleus in Surgery for Herniated Discs
San Diego, CA – (PRNewswire-FirstCall) – July 26, 2004
Protein Polymer Technologies, Inc. (BULLETIN BOARD: PPTI) today announced that its licensee, Spine Wave, Inc., has notified PPTI of its intent to initiate commercial manufacture of NuCore(TM) Injectable Disc Nucleus (IDN), an injectable protein polymer formulation for repair of spinal discs damaged as a result of injury or aging. Spine Wave recently received approval to begin human clinical testing of NuCore(TM) IDN in Europe. As a result of the notice, PPTI and Spine Wave will begin negotiations on the terms and conditions for PPTI's provision of commercial manufacturing services.
NuCore(TM) IDN, based on PPTI's patented tissue adhesive technology, is injected as a liquid that quickly cures to a solid hydrogel, with properties similar to the natural disc nucleus material. It has the potential to ultimately be used in a minimally invasive outpatient procedure to intervene early in the disc degeneration process and provide r
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