AVI BioPharma Opens GMP Manufacturing Plant For NeuGene Antisense Drugs for Clinical Trials and Commercialization
PORTLAND, Ore. - Feb. 5, 2002 - AVI BioPharma Inc. (Nasdaq: AVII, AVIIW, AVIIZ) today announced the opening of its state-of-the-art good manufacturing practices (GMP) manufacturing facility for NeuGene® antisense 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™ 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 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.
"This is a major accomplishment for AVI," 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™, a therapeutic cancer vaccine, has completed three Phase II trials in colorectal and pancreatic cancer and is in a Phase III pivotal trial 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. More information about AVI is available on the Company's Web site at 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 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 Security and Exchange Commission filings.