AVI BioPharma's Cancer Vaccine to be First Line Treatment of Colorectal Cancer in Phase III Study.Business Editors/Health & Medical Writers PORTLAND, Ore.--(BW HealthWire)--Dec. 21, 1999 AVI BIOPHARMA, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq:AVII, AVIIW, AVIIZ), a biotechnology company committed to the development of products to treat cancer and other life-threatening diseases, announced today the decision to proceed with Phase III clinical trails of the Company's therapeutic cancer vaccine, Avicine(TM) as first line treatment of colorectal cancer in combination with chemotherapy. This decision is based on meeting AVI's primary objectives in its Phase II clinical trials and with discussions with the Food and Drug Administration (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. ). "The continued clinical development of Avicine is an important part of AVI's cancer immunotherapy program," said Denis Denis, king of Portugal: see Diniz. Burger, Ph.D., AVI BioPharma's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We are very pleased with the data from our Phase II trials. The safety and efficacy of this therapeutic vaccine has now been evaluated in more than 180 patients with cancer. In our Phase III study, Avicine will move from second line therapy to first line treatment of metastatic colorectal cancer." AVI has prepared and submitted the final analysis of the Phase II data for publication in a peer reviewed medical journal and for presentation at the upcoming May 2000 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 ) scientific meeting. Specific plans for the Phase III trial are underway. AVI will sponsor the trial using a protocol developed with leading clinical oncologists and with input from the FDA. The clinical investigation involves 500 patients 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. to either Avicine in combination with chemotherapy or to chemotherapy alone and will start in 2000. AVI is currently conducting a Phase II clinical trail in patients with pancreatic cancer treated with Avicine alone or Avicine in combination with gemcitabine (Gemsar(R)) produced by Eli Lilly & Co (NYSE NYSE See: New York Stock Exchange :LLY). Avicine is an essentially nontoxic therapeutic cancer vaccine which elicits a highly specific immune response to the human hormone and growth factor chorionic gonadotropin (hCG), a cancer-associated oncofetal protein. The vaccine blocks the hormonal potentiation potentiation /po·ten·ti·a·tion/ (po-ten?she-a´shun) 1. enhancement of one agent by another so that the combined effect is greater than the sum of the effects of each one alone. 2. posttetanic p. of 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. . In the clinical trials to date, patients that responded to the peptides in the vaccine exhibited significant survival benefits compared to patients treated with chemotherapy alone. Colorectal cancer is the third most frequent cancer type in the U.S. with approximately 131,000 diagnoses and 55,000 deaths in 1998. Approximately one in 17 Americans will develop colorectal cancer in their lifetime. Patients with metastatic colorectal cancer are currently treated with combination chemotherapy consisting of 5-fluorouracil (5-FU) and Camptosar(R) (Pharmacia & Upjohn, Inc. (NYSE:PNU)). AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: cancer immunotherapy and gene-targeted drugs. Its lead clinical agent, Avicine, a therapeutic cancer vaccine, is in a Phase II trial in pancreatic cancer, and will soon enter a Phase III pivotal trial in colorectal cancer and a Phase II trial in Prostate cancer. AVI has begun clinical trials on Resten-NG in cardiovascular restenosis, the first application of its novel third generation NeuGene antisense technology. 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 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. For more information about the Company, visit AVI's website at http://www.avibio.com. 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 pre-clinical 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. |
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