AVI BioPharma to Present AVICINE Pancreatic Cancer Survival Data At American Society of Clinical Oncology.Business Editors & Health/Medical Writers PORTLAND, Ore.--(BW HealthWire)--May 21, 2002 AVI BioPharma, Inc. (Nasdaq:AVII) (Nasdaq:AVIIW) (Nasdaq:AVIIZ) will present complete survival data from a Phase II trial of the company's AVICINE(R) cancer vaccine today at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ). 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(R), Eli Lilly & Co., NYSE NYSE See: New York Stock Exchange : LLY). The randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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 (Audio Video Interleaved) A Windows multimedia video format from Microsoft. It interleaves standard waveform audio and digital video frames (bitmaps) to provide reduced animation at 15 fps at 160x120x8 resolution. Audio is 11,025Hz, 8-bit samples. 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 chorionic pertaining to the chorion. chorionic girdle a circular band of cells of placental origin that invade the endometrium and form the endometrial cups in the mare. gonadoptropin (hCG), a cancer-associated oncofetal protein. The vaccine blocks hCG's function, which is to facilitate tumor growth, angiogenesis, invasion and immunosuppression immunosuppression Suppression of immunity with drugs, usually to prevent rejection of an organ transplant. Its aim is to allow the recipient to accept the organ permanently with no unpleasant side effects. . 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(R) 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(TM), is designed to treat cancer, cardiovascular restenosis and other cell proliferation disorders by inhibiting the production of a cellular transcription factor, the oncogene oncogene Gene that can cause cancer. It is a sequence of DNA that has been altered or mutated from its original form, the proto-oncogene (see mutation). Proto-oncogenes promote the specialization and division of normal cells. c-myc. It is currently in Phase II trials for restenosis and in Phase I/II trials for cancer and polycystic kidney disease Polycystic Kidney Disease Definition Polycystic kidney disease (PKD) is one of the most common of all life-threatening human genetic disorders. . 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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. |
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