AVI BioPharma Initiates Phase II Cardiovascular Clinical Study in Europe
PORTLAND, Ore. — Sept. 20, 2005 — AVI BioPharma, Inc. (Nasdaq: AVII), today announced the initiation of patient enrollment in Germany for the company’s APPRAISAL Phase II clinical study. The APPRAISAL trial is designed to evaluate AVI’s Resten–MP™ in the prevention of cardiovascular restenosis when delivered intravenously in conjunction with the placement of one or more bare–metal stents.
Resten–MP is AVI–4126 delivered via intravenous injection using AVI’s patented microparticle delivery technology. In preclinical studies, Resten–MP was as effective as AVI–4126 delivered by catheters or stents in preventing cardiovascular restenosis.
“Restenosis continues to impede effective long–term interventional cardiology,” said Peter D. O’Hanley, Ph.D., M.D., M.P.H., senior vice president of clinical development and regulatory affairs at AVI. “Even with widespread use of drug–eluting stents (DES) in the U.S., several patient populations, such as those with diabetes, still experience restenosis and could benefit from alternative therapies.”
The drug component in Resten–MP, AVI–4126 (Resten–NG®), was found to prevent restenosis in the AVAIL Phase II clinical trial. In this multicenter study, Resten–NG was injected directly into the coronary artery using a special drug delivery catheter at the time of stent placement. Resten–NG in the therapeutic dose arm demonstrated statistically significant efficacy in preventing restenosis determined by both quantitative angiography and intravascular ultrasound compared with a control arm and a subtherapeutic dose arm. Further, Resten–NG significantly reduced the neointimal growth that contributes to the failure of angioplasty intervention. The binary restenosis rate was reduced by 75 percent among patients who received a therapeutic dose.
“AVI is also conducting a Phase II clinical study with Resten–MP delivered intravenously at the University of Nebraska Medical Center in combination with the Taxus stent,” said Denis R. Burger, Ph.D., chief executive officer of AVI. “Taken together, the two ongoing studies are designed to evaluate the benefit of AVI–4126 in combination with drug–eluting stents, and whether the long–term complications seen in some drug–eluting stent data can be avoided by using Resten–MP in combination with bare–metal stents.” AVI–4126 is a third–generation antisense agent that targets the key regulatory gene involved in cardiovascular restenosis, the transcription factor referred to as c–myc. C–myc is believed to regulate the many downstream genes that produce the pathology of restenosis, including cell migration and adhesion, collagen formation, secretion of extra–cellular matrix, and cell proliferation.
About the study
The primary therapeutic endpoint of the study is the subsequent reduction in luminal diameter (late loss) from the time of intervention to follow–up at six months, as measured by quantitative angiography and intravascular ultrasound. Reduction in late loss is the standard indicator cardiologists use to gauge long–term stent efficacy.
The University of Essen in Germany is the principal investigative center. Prof. Dr. med. Raimund Erbel, director of cardiology at the center, has appointed PD Dr. Stefan Sack as the principal investigator to coordinate the study with the other German centers participating in the trial, including the University of Heidelberg and the Coburg Clinical Center.
AVI is conducting this study in collaboration with Harvard Clinical Research Institute (HCRI), an internationally recognized organization specializing in the management of coronary artery disease and stents. A validated historical database with over 20,000 patients will be used by HCRI as the comparator in this initial advanced clinical phase study.
Donald Cutlip, M.D., chief medical officer at HCRI, said, “This statistically robust clinical study should determine if Resten–MP has clinical benefit to patients that would receive a bare–metal coronary artery stent. If Resten–MP can significantly reduce late lumen loss at six months compared to the historical control, there is every confidence that pivotal studies would demonstrate the therapeutic value of the drug.”
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life–threatening diseases using third–generation NeuGene® antisense drugs. 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 combat disease by targeting single–stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus and Ebola virus. 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.