AVI BioPharma Confirms Availability of Additional Route Of Administration for NeuGene® Antisense Drugs
Portland, Ore. - Oct. 24, 2002 - AVI BioPharma, Inc. (NASDAQ: AVII, AVIIW, AVIIZ), today announced it has completed pharmacokinetic (PK) analyses that showed the availability of an additional safe and efficacious route of administration for the Company's proprietary NeuGene® antisense compounds. The PK data stem from a previously announced study targeting a key liver enzyme.
The recently completed PK analyses demonstrated that the subcutaneous route of administration results in dose-dependent elevations in blood concentrations of NeuGeneS. Successful subcutaneous administration offers the opportunity for future development of convenient, sustained-release formulations of NeuGeneS.
"This proof of concept in humans of the successful application of an additional critical route of administration further broadens the utility of our proprietary NeuGene antisense," said Denis R. Burger, Ph.D., CEO of AVI. "In addition to potentially treating virtually any disease under genetic control, we will be able to use optimal routes of administration of our compounds in a disease-dependent manner."
These detailed analyses stemmed from a previously announced 96-patient study completed earlier in the year in which a NeuGene antisense compound was used to target cytochrome P450 3A4, a key liver enzyme responsible for the metabolic breakdown of approximately 50 percent of current FDA-approved drugs. Inhibition of the expression of the enzyme significantly changed the metabolism of a test drug, BuSpar® (Buspirone HC1, USP, Bristol-Myers Squibb), in a predictable manner in trial participants.
"We have now established that NeuGene antisense can predictably alter gene expression in humans using multiple routes of administration," said Patrick L. Iversen, Ph.D., senior vice president of Research and Development at AVI. "To do so with the safety profile we have shown in our human trials is a truly exciting breakthrough in treating disease."
The 96 trial subjects were divided into two groups. The first group established the safety of the NeuGene treatment via dose escalations with two routes of administration. In that portion of the trial, there were no drug-associated toxicities in any of the 48 patients, all of whom were monitored for adverse events, organ function and laboratory results.
The second group of 48 subjects was tested for the effect of down-regulating the target enzyme, and that enzyme's relationship to the PK of BuSpar. When the PK of BuSpar in each subject was compared before and after NeuGene administration, AVI demonstrated that cytochrome P450 was inhibited in a predictable dose-dependent fashion, expressed as a longer half-life and increased blood level of BuSpar in the patient population.
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 I/II 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 also recently completed a Phase I/II trial in polycystic kidney disease. 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.