AVI BioPharma Opens GMP Manufacturing Plant For NEUGENE Antisense Drugs for Clinical Trials and Commercialization.Business Editors & Health/Medical Writers PORTLAND, Ore.--(BW HealthWire)--Feb. 5, 2002 AVI BioPharma Inc. (Nasdaq:AVII) (Nasdaq:AVIIW) (Nasdaq:AVIIZ) today announced the opening of its state-of-the-art good manufacturing practices (GMP GMP (guanosine monophosphate): see guanine. ) manufacturing facility for NEUGENE(R) 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). drugs. This pharmaceutical manufacturing plant will be the site for production of bulk NEUGENE drugs for preclinical and clinical development, product launch and commercialization. The facility also contains a series of finished dosage form suites designed to support the development of injectable products. The facility will soon produce the Resten-NG(TM) needed for Phase II and Phase III clinical trials in cardiovascular restenosis and eventually will be the commercial source of the antisense material for several of AVI's drug development programs. Resten-NG is a NEUGENE compound directed against c-myc, a gene involved in cell proliferation disorders such as cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and cancer. AVI BioPharma is involved in ongoing Phase I and Phase II clinical trials with antisense drugs applied to the c-myc gene target in cardiovascular disease, 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. . "This is a major accomplishment for 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. ," said Dwight Weller, Ph.D., senior vice president for Chemistry and Manufacturing at AVI BioPharma. "Manufacturing GMP-quality material is a challenging and necessary step in the process of commercializing any product. By bringing GMP pharmaceutical production in-house, we intend to expedite the movement of antisense products through AVI's development pipeline. We are especially excited that our third-generation antisense technology now may be produced on a commercial scale." David H. Mason, Jr., M.D., senior vice president for Clinical Development and Regulatory Affairs at AVI BioPharma, said, "We are pleased to announce this major milestone for AVI. Advanced clinical trials are appropriately supported by the production and use of GMP material. We are at that point in our clinical programs where we are anticipating Phase III studies and eventual product registration. The commissioning of this facility gets us much closer to where we need to be to launch the first of our products." 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(TM), a therapeutic cancer vaccine, has completed three Phase II trials in colorectal and 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. and is in a Phase III pivotal trial in 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. . 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 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. 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 Security and Exchange Commission filings. |
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