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Resten-NG (PCI)

Sarepta Therapeutics, Inc.

Drug Names(s): Resten-MP; AVI-4126, Third-generation NEUGENE compound

Description: Resten-NG is an antisense agent that targets the c-myc gene, which is believed to regulate the downstream genes that produce the pathology of restenosis: cell migration and adhesion, collagen formation, secretion of extra-cellular matrix, and cell proliferation, among others. The c-myc gene is immediately activated by the injury to the vascular lining during angioplasty and stent placement and peaks at 24 to 48 hours before subsiding.

AVI is developing products principally based on its NEUGENE antisense technology. Antisense compounds are designed to bind to specific disease-causing gene sequences to disable or inactivate the disease process. AVI has developed proprietary third-generation antisense compounds called NEUGENES, which includes Resten-NG, and are characterized by a novel synthetic backbone, instead of the modified backbones of competing technologies.

Resten-MP is a microparticle formulation of Resten-NG that can be delivered intravenously.

Resten-CP is Resten-NG with AVI's proprietary CytoPorter (CP) attached to enhance delivery to the saphenous vein ex vivo before its use in bypass surgery.

Deal Structure: In March 2006, AVI BioPharma entered into an agreement with Cook Group Inc. (Cook) where Cook took over clinical development of Resten-NG in the PCI indication. Cook will fully fund the development, clinical and regulatory costs of this program in the U.S. and Europe leading to commercialization. AVI has forgone certain nearterm milestone payments in favor of a low doubledigit royalty on worldwide product sales and a commercialization milestone.

Partners: Cook Group, Inc.

Resten-NG (PCI) News

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