AVI BioPharma Advances NeuGene Antisense Cancer Program
Phase II Pancreatic Cancer Trial Planned for Second Half of 2003
PORTLAND, Ore.--(Nasdaq: AVII, AVIIW, AVIIZ)--March 26, 2003--AVI BioPharma, Inc. (Nasdaq:AVII - News; Nasdaq:AVIIW - News; Nasdaq:AVIIZ - News), today announced progress with its NeuGene® antisense cancer program targeting the oncogene c-myc.
Amplification of this gene has been described in many types of cancers, including lymphomas, pancreatic cancer, breast cancer, colon cancer, stomach and ovarian cancers, and multiple myeloma. AVI has completed Phase I clinical trials with AVI-4126, a NeuGene compound targeting this key oncogene.
AVI-4126 has been investigated in multiple clinical trials. 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 adverse events. In addition, interim data from the Phase II restenosis study indicated effectiveness in preventing restenosis, consistent with preclinical studies. Final results from the Phase II restenosis study and the Phase Ib cancer study are expected to be available in the second quarter of 2003.
Denis Burger, chief executive officer at AVI, said, "These extensive investigations establish the basis for our planned Phase II cancer program for AVI-4126. We believe that target choice is paramount in cancer studies, and c-myc has substantial research and backing. Discovery and understanding of this gene and its role in cancer led to a Nobel Prize for J. Michael Bishop and Harold Varmus."
In preclinical models, AVI scientists demonstrated that AVI-4126 specifically inhibits the growth of prostate cancer cells, and that this activity translates into anti-tumor effectiveness. In combination with other agents, AVI-4126 inhibits tumor growth and produces complete tumor regression. These effects have been shown to be specific to the antisense drug, with AVI-4126 blocking the expression of the target gene, resulting in a decrease in c-myc protein. Blocking of this gene produced the desired anti-tumor effects.
David Mason, M.D., senior vice president of clinical development and regulatory affairs at AVI, 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 a Phase II pancreatic cancer trial in the second half of 2003."
AVI-4126 is based on AVI's patented third-generation antisense technology. In preclinical and clinical studies, AVI-4126 appears to produce less toxicity than other antisense drugs. This could lead to dosing flexibility in cancer patients, particularly as studies will employ combinations with toxic chemotherapeutic agents.
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 Phase II trials for restenosis and in a Phase Ib trial for cancer. AVI has completed a Phase I NeuGene antisense study that successfully down-regulated the liver enzyme cytochrome P450 and modified drug metabolism, and a Phase Ib trial in polycystic kidney disease. More information about AVI is available on the Company's Web site at http://www.avibio.com/.
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