Corautus signs agreement with Boston hospital for tests of VEGF-2

By Ted A. Knutson

Washington, Jan. 11 - Corautus Genetics Inc. announced Wednesday that it has agreed to support the clinical trial of Caritas St. Elizabeth's Medical Center of Boston in evaluating the safety and efficacy of VEGF-2 for the treatment of patients suffering with moderate or high-risk Critical Limb Ischemia.

Under the agreement, Corautus will provide its proprietary vascular endothelial growth factor, VEGF-2, to Caritas St. Elizabeth's Medical Center of Boston for evaluation in a 64-patient, phase 1 trial for the treatment of Critical Limb Ischemia. The medical center is the sponsor of this clinical trial, which will be conducted under a funding grant from the National Institutes of Health.

VEGF-2 is a naturally occurring growth factor that is believed to promote the development of supplemental collateral blood vessels, a process known as therapeutic angiogenesis. Once administered, the DNA plasmid appears to be taken up and expressed by tissue near the injection site. Inside the cell the DNA plasmid then enters the nucleus of the cell without requiring incorporation into the genomic DNA.

The clinical trial being undertaken by the medical center expects to evaluate whether the expression of DNA-encoded VEGF-2 will stimulate the growth of new blood vessels by promoting the migration and proliferation of endothelial cells, thereby increasing blood flow to nerve cells in the area.

Critical Limb Ischemia is a severe manifestation of peripheral artery disease that can necessitate partial or complete amputation of the affected limb, usually a leg. The condition is characterized by persistent ischemic rest pain in the affected limb and is often accompanied by skin ulceration that does not improve without clinical intervention. The diminished healing ability and persistent or recurring limb pain are due to chronic decreased blood circulation to the limb, typically resulting from atherosclerosis.

The risk factors for Critical Limb Ischemia, therefore, are similar to those linked to coronary artery disease and include advanced age, smoking, diabetes, hyperlipidemia and hypertension. The worldwide incidence of Critical Limb Ischemia has been estimated to be 500 to 1,000 cases per million people per year.

If phase I trial data is promising, Corautus has the right to use and reference the Caritas St. Elizabeth's Medical Center of Boston clinical trial data as part of its own Critical Limb Ischemia clinical program. In July 2003, Corautus entered into a strategic alliance with Boston Scientific Corp. to develop, commercialize and distribute the VEGF-2 gene therapy products, which includes treatment in the peripheral vascular system, such as Critical Limb Ischemia.

Dr. Douglas W. Losordo, program director of NIH Grant for Excellence in Gene Therapy and chief, cardiovascular research at St. Elizabeth's, said in a news release, "Patients with CLI [Critical Limb Ischemia], a severe form of peripheral artery disease, have few treatment options once the disease has progressed to this stage. Following significant research, pre-clinical testing, and smaller human studies, we concluded that VEGF-2 holds potential as a new therapy for a large patient population with few therapeutic alternatives."

Atlanta-based Corautus is a biopharmaceutical company dedicated to the development of gene transfer therapy products for the treatment of cardiovascular (severe angina) and peripheral vascular disease.

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