AVI BioPharma Reports Positive Results From NeuGene Cancer Trial
Antisense Drug Detected in Breast and Prostate Tumors
PORTLAND, Ore. - June 19, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ), today announced positive results from a Phase Ib clinical trial with its NeuGene® antisense cancer drug, AVI-4126, targeting the oncogene c-myc. The trial demonstrated the effectiveness of systemic drug delivery into solid tumor tissues for both breast and prostate cancer patients. Over-expression of c-myc has been described in these and many other types of cancer.
Tumors were surgically excised 24 hours after IV bolus injection of AVI-4126. Specimens from the excised tumors were then analyzed for drug concentration. In both tumor types, the drug levels detected substantially exceeded the concentration required for effective inhibition of the gene target. These findings are consistent with our previously published observations from a variety of tumor specimens collected in nonhuman studies. Drug-level analyses were conducted at AAI Development Services, Shawnee, Kan., and employed validated assays for detecting AVI antisense agents.
Denis R. Burger, Ph.D., AVI's chief executive officer, said, "To our knowledge this is the first formal demonstration that antisense drugs can be detected in remote cancer tissues after systemic administration. Although basic to our understanding of the mechanism of antisense cancer therapy and to sound pharmaceutical development principles, these observations are the first of their kind. We also believe that target choice is paramount in cancer studies, and substantial research indicates that c-myc is an important cancer target."
In preclinical models, AVI scientists had previously demonstrated that AVI-4126 specifically inhibits the growth of lung cancer cells, and that this activity translates into antitumor effectiveness. In combination with other agents, AVI-4126 inhibits tumor growth and can produce complete tumor regression. These effects have been shown to be specific to the NeuGene antisense drug, with AVI-4126 blocking the expression of the target gene and producing the desired antitumor effects.
AVI-4126 is based on AVI's proprietary third-generation antisense technology. AVI-4126 has been investigated in multiple clinical trials in cancer and other diseases where the c-myc gene contributes to the disease. Completed studies include Phase I studies in normal volunteers, Phase Ib studies in patients with cancer and polycystic kidney disease, and a Phase II study in cardiovascular restenosis. More than 100 patients and volunteers have been given AVI-4126 without observation of drug-related side effects.
David H. Mason, Jr., M.D., AVI's senior vice president for Clinical Development and Regulatory Affairs, said, "We are very excited by our progress with this antisense agent. Our key oncology consultants are enthusiastic about AVI-4126 and its potential to be useful in a variety of malignancies. We expect to initiate additional cancer studies within the next few months."
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 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™, 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 a Phase II trial for restenosis. AVI has completed a Phase I NeuGene antisense study that successfully down-regulated the liver enzyme cytochrome P-450 and modified drug metabolism, a Phase Ib trial in polycystic kidney disease, and a Phase Ib trial in cancer. 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 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 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.