AVI BioPharma to Present AVICINE Pancreatic Cancer Survival Data At American Society of Clinical Oncology
PORTLAND, Ore. - May 21, 2002 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ) will present complete survival data from a Phase II trial of the company's AVICINE® cancer vaccine today at the American Society of Clinical Oncology (ASCO). Patrick L. Iversen, Ph.D., AVI's senior vice president of research and development, will present "Active Beta-hCG-Specific Immunotherapy in Patients With Pancreatic Cancer" at ASCO's annual conference today in Orlando, Fla.
In the recently completed Phase II trial, pancreatic cancer patients were treated with AVICINE alone or in combination with gemcitabine (Gemzar®, Eli Lilly & Co., NYSE: LLY). The randomized, multicenter trial was designed to evaluate the safety and effectiveness of these treatments. Those patients treated only with AVICINE experienced no significant vaccine-related side effects, and the one-year survival rate for the group treated only with AVICINE was similar to that reported historically for Gemzar (approximately 15 percent). More important, the group that was treated with both AVICINE and Gemzar had a significantly improved one-year survival rate of 30 percent. Based on these results, AVI plans to initiate Phase III studies of AVICINE in pancreatic cancer in late 2002 with its U.S. marketing and co-development partner, SuperGen Inc.
The Phase III pancreatic cancer clinical trial design involves three treatment arms of approximately 200 patients each: AVICINE vaccine alone, gemcitabine (Gemzar, Eli Lilly & Co., NYSE: LLY) alone, and AVICINE in combination with Gemzar. The primary endpoints will be median survival and one-year survival.
"The value of new cancer therapies is measured according to survival data and toxicity, both of which offered promising indications in this Phase II AVICINE study," stated Dr. Iversen. "Pancreatic cancer is a devastating disease and difficult to treat, and we believe that the encouraging Phase II data will be replicated in our Phase III pancreatic cancer clinical trial."
About AVICINE
AVICINE is a therapeutic cancer vaccine that elicits a highly specific
immune response to human chorionic gonadoptropin (hCG), a
cancer-associated oncofetal protein. The vaccine blocks hCG's function,
which is to facilitate tumor growth, angiogenesis, invasion and
immunosuppression. The most common side effects of AVICINE are mild
reactions at the site of injection. Six completed clinical trials have
shown that it is considerably less toxic than traditional chemotherapy.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: NeuGene® antisense drugs and cancer immunotherapy. Its lead cancer agent, AVICINE, a therapeutic cancer vaccine, has completed three Phase II trials in colorectal and pancreatic cancer and is initiating a Phase III pivotal trial in pancreatic cancer, with a supporting study in colorectal cancer. The first application of its NeuGene compounds, Resten-NG™, is designed to treat cancer, cardiovascular restenosis and other cell proliferation disorders by inhibiting the production of a cellular transcription factor, the oncogene c-myc. It is currently in Phase II trials for restenosis and in Phase I/II trials for cancer and polycystic kidney disease. AVI has recently completed a Phase I NeuGene antisense study that successfully down-regulated the liver enzyme Cytochrome P450 and modified drug metabolism. More information about AVI is available on the Company's Web site at http://www.avibio.com/.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings.