AVI BioPharma Reports Anti-Cancer Effects and Single-Dose Bioavailability With NeuGene Antisense Compounds
Data Presented at the 2004 American Association for Cancer Research Annual Meeting
PORTLAND, Ore. - April 1, 2004 - AVI BioPharma, Inc. (Nasdaq: AVII), today announced the presentation of positive results demonstrating the success of its NeuGene® antisense compounds in two novel targeting approaches to cancer. The studies were presented this week at the 2004 American Association for Cancer Research Annual Meeting.
The first study, "Neutrally Charged Phosphorodiamidate Morpholino Antisense Oligomers: In Vivo Bioavailability in Solid Tumors," was presented by AVI senior scientist Gayathri R. Devi. Included was a detailed characterization of various factors that affect in vivo biodistribution and efficacy of NeuGene antisense compound AVI-4126 administered in multiple animal models and in a Phase I clinical study. The objectives of the Phase I study were to evaluate the safety of AVI-4126, and to determine the concentration and distribution of the NeuGene in tissue samples from the tumors. The results support earlier studies using animal models, showing that AVI-4126, which targets the c-myc gene, concentrates in the tumor tissues of patients with both breast and prostate cancer after just a single dose.
"Collectively, these clinical and preclinical studies demonstrate clear in vivo bioavailability of our antisense compound," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "In addition, the fact that we achieved bioavailability in the target tissues after only a single dose of AVI-4126 suggests that once-a-day dosing may be possible."
The second study, "XIAP Inhibition Induces Apoptosis and Enhances Chemotherapy Sensitivity in Human Prostate Cancer Cells," was presented by AVI scientist Adams Amantana. The study demonstrated that the X-linked inhibitor of apoptosis protein (XIAP) is one of the critical factors in conferring chemotherapy resistance in human prostate cancer cells. Using a NeuGene antisense compound that is designed to block the gene that produces XIAP, AVI scientists demonstrated the critical role this protein plays in allowing certain tumor cells to evade the effects of chemotherapy. Results demonstrated that when administered in combination with the chemotherapy drug cisplatin, AVI's XIAP-inhibiting NeuGene compound induced apoptosis, or cell death, in the chemotherapy-resistant prostate cancer cells.
"Our second study demonstrated how antisense can be used to increase overall cancer cell sensitivity to chemotherapy," Iversen said. "It is well known that XIAP acts as a potent anti-apoptotic factor, helping some cancer cells evade the effects of chemotherapy. By treating chemotherapy-resistant human prostate cancer cells with an antisense compound designed to block XIAP, we showed it is possible to make the cells sensitive to chemotherapy again, which means they can still be treated effectively."
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: third-generation NeuGene antisense drugs and cancer immunotherapy. AVI's lead NeuGene antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. In addition to targeting specific genes in the body, AVI's antiviral program uses NeuGene antisense compounds to target single-stranded RNA viruses, including West Nile virus, SARS coronavirus, calicivirus and hepatitis C. AVI's second technology, Avicine®, is a therapeutic cancer vaccine with late-stage trials planned for the treatment of pancreatic 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.