AVI BIOPHARMA And ImmunoTherapy Corporation Announce the Initiation of a Late-Stage Clinical Trial for Their Therapeutic Cancer Vaccine.PORTLAND, Ore.--(BW HealthWire)--June 3, 1998--AVI BIOPHARMA (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. )(Nasdaq: AVII, AVIIW) and ImmunoTherapy Corporation (ITC ITC (Brit) n abbr (= Independent Television Commission) → Fernseh-Aufsichtsgremium ITC n abbr (BRIT) (= Independent Television Commission) → ) today announced that they have selected Premier Research Worldwide (PRWW), a leading contract research organization, to conduct an additional clinical trial of the therapeutic cancer vaccine, AVICINE(tm), for the treatment of pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. . PRWW will conduct a multi-center study in the United States, managed to conform to both U.S. and European regulatory approval requirements. A total of 48 pancreatic cancer patients will be evaluated in the Phase II/III study comparing AVICINE alone, the Eli Lilly & Co. (NYSE NYSE See: New York Stock Exchange : LLY) chemotherapy drug Gemzar(R) alone, or the combination of AVICINE and Gemzar. The clinical study will provide a comparison of quality of life and incidence of survival in the three patient populations. This study marks the first time that a combination of chemotherapy and this type of therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. have been evaluated against each modality on their own. AVICINE has been manufactured under GMPs for these clinical studies and patient enrollment is expected to begin in the next two to three months with a total study time of approximately one year. To date, more than 125 cancer patients have been treated with AVICINE, which completed Phase II multi-center clinical studies for pancreatic cancer and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. in early 1998. These trials provided evidence of objective anti-tumor responses, stabilization of tumor growth and apparent survival and quality of life benefits in some patients. AVI and ITC expect to begin a Phase III licensing trial in colorectal cancer later this year. "We are pleased to have been chosen by AVI BioPharma and ITC to conduct their multi-center Phase II/III clinical trial of AVICINE to treat pancreatic cancer," said Joel Morganroth, M.D., Chief Executive Officer of PRWW, based in Philadelphia, Pennsylvania. "Using our extensive expertise in conducting clinical trials in cancer, we are excited about identifying Avicine's therapeutic potential." Denis Denis, king of Portugal: see Diniz. R. Burger, Ph.D., 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. of AVI BioPharma and Jeffrey Lillard, Managing Officer of ITC, stated, "The advancement of this clinical research program is an important part of our long-term growth strategy. To that end, we are confident in PRWW's ability to manage the Phase II/III clinical trial of AVICINE in pancreatic cancer patients and we look forward to working with them in completing this important study. As we enter the final stages of drug development, we are encouraged by the vaccine's results to date, and believe that we have developed a non-toxic therapy with the potential to capitalize on the unfulfilled $2 billion cancer vaccine market." Dr. Burger continued, "With this significant milestone in place, we have established a strong portfolio of vaccine products in late-stage clinical testing. We believe our advanced clinical programs will allow us to attract a strategic marketing partner to support our continued development efforts and longer-term commercial prospects." AVI BioPharma, formerly known as AntiVirals Inc., is dedicated to the development and commercialization of products for the treatment of life-threatening diseases. In the antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). field, the company has developed a patented class of gene targeted drugs, called NEUGENES(R), which may be useful in the treatment of a wide range of human diseases including cancer and restenosis, a cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease . The company has also developed a drug delivery technology, called CYTOPORTER(tm), which may be useful in improving delivery of many FDA-approved drugs, drugs in development, and antisense compounds. In February 1998, AVI BioPharma and ITC entered into an agreement, whereby AVI will acquire ITC. The acquisition has been approved by the Board of Directors of both companies and is pending ITC and AVI shareholder approval. -0- "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 pre-clinical 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.
CONTACT: Denis R. Burger, Ph.D.
President & CEO
Alan P. Timmins
COO & CFO
AVI BioPharma
(503) 227-0554
or
INVESTOR RELATIONS CONTACT:
Olga M. Fleming
Sue L. Yeoh
CPR Financial Communications, LLC
(201) 641-1911
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