AVI BioPharma, Inc. has entered into agreements with Cook Group Inc. (Cook) for Cook's development and commercialization of products for vascular diseases.

Cook has specifically licensed AVI's NeuGene antisense technology for down-regulating c-myc gene expression in the field of cardiovascular disease. Cook will take over clinical development of AVI's device-related programs for cardiovascular restenosis, including its Resten-NG drug-eluting stent (DES) program, Resten-MP microparticle delivery program and its new program for catheter delivery of Resten-NG.

According to the company release, Cook has also entered into a supply agreement to purchase the drugs for development, clinical studies and commercialization from AVI. Because of the drugs' established Phase II clinical efficacy, AVI has forgone certain near-term milestone payments in favour of a double-digit royalty on worldwide product sales and a commercialization milestone. Cook will purchase 692,003 shares of AVI common stock for $5 million under a stock purchase agreement. Cook will take over AVI's facilities and personnel at its Colorado site. Additional terms of the agreements were not disclosed.

"Based upon promising Phase II clinical data in combating cardiovascular restenosis and progress in our drug-eluting stent and Resten-MP programs, AVI has now partnered its device-related cardiovascular programs with one of the pre-eminent vascular device companies in the world," Denis R. Burger, chief executive officer of AVI said adding, "Together, Cook's device expertise and AVI's antisense technology become a formidable combination to address vascular diseases on many fronts."

AVI will narrow its internal cardiovascular focus exclusively to its coronary artery bypass graft (CABG) program, which is moving into Phase II clinical trials later this year. This agreement also enables AVI to apply resources more aggressively toward the company's infectious disease program, focusing on hepatitis C and influenza A, including avian influenza type H5N1.

Resten-NG (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. It is believed that it regulates the many downstream genes which produce the pathology of restenosis, namely cell migration and adhesion, collagen formation, secretion of extra-cellular matrix, and cell proliferation, among others. The c-myc gene expression is immediately activated by the injury to the vascular lining during angioplasty and stent placement and peaks at 24 to 48 hours before subsiding. NeuGene antisense drugs are particularly suited to prevent this process because they can be delivered immediately following injury to the angioplasty site by a variety of means including catheter and stent elution, or by systemic delivery using AVI's microparticle delivery system, Resten-MP.