AVI BioPharma to Initiate Second West Nile Virus Clinical Study With NeuGene Antisense Drug
PORTLAND, Ore. - Oct. 8, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII), today announced it would begin a second clinical study evaluating its NeuGene® antisense drug AVI-4020 in patients with West Nile virus (WNV). The new study will allow expanded access to the Company's proprietary drug in response to requests from physicians for access to AVI-4020 for seriously ill patients who have limited treatment options. AVI's ongoing clinical trial evaluating AVI-4020 continues to actively enroll patients.
The new study will allow physicians to obtain AVI-4020 for their patients via requests through an FDA-approved protocol. Data from the new study will provide additional safety and efficacy information for further clinical development of AVI-4020.
David H. Mason, Jr., M.D., AVI's senior vice president for Clinical Development and Regulatory Affairs, commented, "The extent of this year's West Nile virus epidemic is unprecedented. We continue to receive inquiries about our program and requests for access to AVI-4020. The initial experience with this drug has been encouraging, and we have designed a second protocol that will allow us to provide expanded access to our drug. We greatly appreciate the support and assistance of the U.S. Food and Drug Administration as we move this project forward."
The second study protocol is less complex than the initial study and does not include pharmacokinetic parameters or a placebo group. It will have full safety monitoring and efficacy parameters and will allow the Company to add to its database of knowledge about AVI-4020 and West Nile virus as the WNV season comes to a close in the next few weeks.
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 cardiovascular restenosis, cancer, polycystic kidney disease and other cell proliferation disorders. 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 and colorectal cancer. More information about AVI is available on the Company's Web site at http://www.avibio.com/.
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