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To: Libbyt who wrote (41083)	6/2/2003 8:46:09 AM
From: MulhollandDrive	Respond to of 57110

targets being raised on DNA... Positive Results from Phase III Avastin Study in Metastatic Colorectal Cancer Presented at ASCO Sunday June 1, 12:30 pm ET First Anti-Angiogenic Therapy to Improve Survival for Metastatic Colorectal Cancer Patients CHICAGO--(BUSINESS WIRE)--June 1, 2003-- Genentech, Inc. (NYSE:DNA - News) today announced that a randomized Phase III study in previously-untreated metastatic colorectal cancer patients evaluating Avastin(TM) (bevacizumab, rhuMAb-VEGF) plus chemotherapy versus chemotherapy alone met its primary endpoint of improving overall survival, as measured by a hazard ratio. Patients receiving Avastin plus chemotherapy had a 50 percent increase in their chance for survival compared to patients who received chemotherapy alone. Conversely, this corresponds to a hazard ratio of 0.65 (p=0.00003). The overall survival data suggest a stronger patient benefit than anticipated, as the study was designed to detect a hazard ratio of 0.75, or a 33 percent increase in chance for survival. ADVERTISEMENT This benefit represents an extension in the median survival of patients treated with Avastin plus chemotherapy by approximately five months, compared to patients treated with chemotherapy alone (20.3 months versus 15.6 months). The study was presented at the 39th annual American Society of Clinical Oncology (ASCO) meeting by Herbert I. Hurwitz, M.D. of the Duke University Medical Center. The median time to disease progression increased 71 percent from 6.2 months in the chemotherapy arm to 10.6 months in the Avastin plus chemotherapy arm (p less than 0.00001), and Avastin plus chemotherapy was also shown to improve overall response rates from 35 percent in the group receiving chemotherapy alone to 45 percent with Avastin plus chemotherapy (p=0.0029). The duration of response increased from 7.1 months with chemotherapy to 10.4 months with Avastin plus chemotherapy (p=0.0014). "The primary and secondary efficacy endpoints, as well as the safety profile, exceeded what the study was designed to demonstrate, and open the door to a potentially new way to treat cancer by inhibiting angiogenesis," said Susan D. Hellmann, M.D., M.P.H., Genentech's executive vice president, Development and Product Operations, and chief medical officer. "The positive results from this clinical trial are an important milestone in the fight against colorectal cancer, and we want to recognize the contributions of the numerous investigators and the courage of the hundreds of patients who participated in this study." Genentech is currently discussing plans for the filing of a Biologics License Application with the U.S. Food and Drug Administration. Avastin is an investigational therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays a critical role in tumor angiogenesis (the formation of new blood vessels to the tumor) and maintenance of existing tumor blood vessels. By inhibiting VEGF, Avastin is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis. "The results of this Phase III study showed that adding Avastin to standard chemotherapy resulted in a significant improvement in how long metastatic colorectal cancer patients lived, how well their tumors shrank, and how long their tumor growth remained under control," said Dr. Hurwitz. "Importantly, these clinical benefits were seen in all groups of patients -- young and old. In addition, there were very few side effects, and those observed in this study were generally mild and manageable, especially compared to standard chemotherapies. Further clinical study is warranted to determine if and how Avastin may be useful in other settings."