Promising Results of AVI BioPharma Colorectal Study Featured In Clinical Cancer Research
PORTLAND, Ore. - July 24, 2002 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ), today announced that its AVICINE® cancer vaccine Phase II clinical trial results in patients with late-stage colorectal cancer are featured in a cover story in the July 2002 issue of Clinical Cancer Research, a publication of the American Association for Cancer Research (AACR).
The article, whose authors include scientist Hong Moulton, Ph.D., Senior Vice President of Clinical Development and Regulatory Affairs David H. Mason Jr., M.D., and Senior Vice President of Research and Development Patrick L. Iversen, Ph.D., all from AVI, highlights improvements in survival in patients who responded to the vaccine.
AVICINE is a therapeutic cancer vaccine designed to stimulate an immune response in the patient, producing antibodies that reduce the presence of human chorionic gonadotropin (hCG), a hormone produced during pregnancy that facilitates fetal development. Significantly, the hormone has also been shown to be present in most, if not all, types of cancer. According to AVI, clinical trials have shown that the specific immune response stimulated by the vaccine has been associated with improved survival rates in both colorectal and pancreatic cancer.
"Stage IV colorectal cancer is one of the toughest forms of cancer to treat; chances of long-term survival for patients at this stage of cancer are not favorable," said Dr. Iversen "We are encouraged by these results and by the results of our Phase II pancreatic cancer study, and believe that AVICINE has a chance of making a real difference in patients with difficult forms of cancer."
About the Study
In an open, randomized Phase II study of 77 patients conducted at 12
clinical sites in the United States, investigators tested AVICINE for
immune response in patients with stage IV colorectal cancer. Anti-hCG
antibodies were detected in 56 of the 77 patients treated. An
intention-to-treat analysis of all vaccinated patients showed a median
survival of 34 weeks. Patients who developed higher anti-hCG antibody
levels exhibited a median survival of 45 weeks. AVI also noted that in
addition to the data presented in this paper, subsequent analysis showed
that patients who produced the antibodies to two segments of the hCG
peptide had a median survival of 66 weeks.
Camptosar®, part of the current standard regimen for treating advanced colorectal cancer, produces a median survival of 37-40 weeks. AVI's AVICINE was well tolerated in this trial and did not produce the severe toxicities associated with standard chemotherapy treatment.
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 Phase I/II trials for cancer and polycystic kidney disease. AVI has recently completed a Phase I NeuGene antisense study that successfully down-regulated the liver enzyme Cytochrome P450 and modified drug metabolism. 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.