Wednesday, Oct 19, 2005
Burlingame, Calif. and South San Francisco, Calif. -- October 19, 2005 --Accelerate Brain Cancer Cure (ABC2), a non-profit foundation, and Genentech, Inc. (NYSE:DNA) today announced a collaboration to explore the potential of Avastin® (bevacizumab) in patients with glioblastoma multiforme (GBM), an especially deadly form of brain cancer. This collaboration is the second alliance between these two entities, based on the ABC2 model of collaborating with the bio-pharmaceutical industry to rapidly move new therapies into the clinic to benefit patients with this devastating disease.
The initial stage of this joint effort is focused on a novel imaging study of patients with recurrent GBM who are enrolled in a Phase II clinical trial at Duke University. Using a DCE technique (dynamic contrast enhancement) as part of a brain MRI scan, researchers hope to explore several potential mechanisms of activity and determine if the early responses seen on the MRI scans are indicators of clinical benefit.
Under the terms of the collaboration, ABC2 will share development expenses with Genentech in this initial stage. If the results are encouraging, ABC2 would then provide access to its resources, including its clinical network of four leading research centers, for a Genentech-sponsored randomized clinical trial in relapsed GBM.
Avastin is a therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels. By binding to VEGF, Avastin is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis. It was the first U.S. Food and Drug Administration (FDA) approved therapy designed to inhibit angiogenesis and is approved for the first-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.
"We are very excited to support Genentech's efforts to study the potential of Avastin in patients with GBM," commented John Reher, ABC2 Executive Director. "Our mission to accelerate a cure for brain cancer depends in large part on screening therapies that are already approved for other diseases, which if proved useful in brain cancer, can quickly be moved through clinical trials and to the patients who need them. The collaboration with Genentech to study Avastin in patients with brain cancer is precisely consistent with our mission."
"Encouraging preliminary data from early-stage research of Avastin in glioblastoma multiforme led us to initiate a Phase II study to gain further insight into Avastin's potential role in this setting," said Gwen Fyfe, M.D., Genentech's vice president of Clinical Hematology/ Oncology. "We look forward to collaborating again with ABC2 and the research centers in their network."
Avastin is a therapeutic antibody designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays an important role in tumor angiogenesis and maintenance of existing tumor vessels. By binding to VEGF, Avastin is designed to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis. The FDA approved Avastin on February 26, 2004 as a first-line treatment for metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. For full prescribing information, including Boxed Warnings for Avastin and information about Avastin and angiogenesis, visit http://www.gene.com or http://www.avastin.com.
Based on data showing that VEGF may play a broad role in a range of cancers, Genentech is pursuing a late-stage clinical development program with Avastin evaluating its potential use in adjuvant and metastatic colorectal, renal cell (kidney), breast, non-small cell lung and ovarian cancers. Avastin is also being evaluated in earlier stage trials as a potential therapy in a variety of solid tumor cancers and hematologic malignancies. For further information about Avastin clinical trials, please call 888-662-6728.
Avastin Safety Profile
Avastin has a well-established safety profile. In Genentech-sponsored studies, the most serious adverse events associated with Avastin were gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, nephrotic syndrome and congestive heart failure. The most common Grade 3-4 adverse events (occurring in greater than two percent of patients in the Avastin arm, compared to the control group) were asthenia, pain, hypertension, diarrhea and leukopenia. The most common adverse events (occurring in greater than two percent of patients in the Avastin arm, compared to the control group) of any severity were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.
About Accelerate Brain Cancer Cure
Accelerate Brain Cancer Cure (ABC2) was founded in May 2001 by Dan and Steve Case and their families, along with leading scientists and entrepreneurs. ABC2 aims to raise awareness about brain cancer and help mobilize critical scientific research through research grants and partnerships. ABC2 funds outstanding and novel translational science that is aimed at the discovery of a cure for brain cancer.
Dan Case, former chairman and chief executive officer of JPMorgan H&Q, died of brain cancer in 2002. Each year more than 17,000 people in the United States find out that they have a malignant primary brain tumor. An additional 100,000 patients are diagnosed with a brain tumor that has metastasized from another part of the body. The mission of ABC2 is to accelerate a cure for brain cancer by increasing the number of potential therapies discovered and then rapidly moving them into the clinic to help patients. In order to accelerate progress in what has been an under-served field of research, ABC2 provides researchers from all backgrounds with the support they need to make critical breakthroughs in brain cancer research. For more information, visit http://www.ABC2.org or contact John Reher at 650/685-2200.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, Calif., and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.