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Theregen's Heart Patch of Living Cells Successfully Placed on First Patient

Posted on: Wednesday, 10 May 2006, 12:06 CDT

A living patch of human cells has been successfully placed for the first time on a patient's diseased heart. Theregen Corporation today announced that a surgical team led by Yale University medical researchers performed the procedure at the Veteran's Administration Hospital in West Haven, Conn. using Anginera(TM), the company's cell-based cardiovascular patch.

The Anginera patch contains human fibroblast cells that secrete multiple biochemical factors essential to forming blood vessels and aiding in tissue repair.

Anginera is in clinical development in a Phase I trial to determine its safety in patients. The patient was undergoing coronary artery bypass graft (CABG) surgery at the time. Anginera patches are applied to the surface (epicardium) of the heart.

"We are very pleased to have reached this important milestone for the Company, as we believe we are one of the first regenerative medicine companies based in the San Francisco Bay Area to initiate human clinical studies," said Michael Siani-Rose, President of Theregen. "It is generally recognized by leading physicians that our patch elicits a profound wound healing response when placed on a topical injury. In this setting, growth factors and cytokines are secreted following patch placement. This multifactorial cascade aids in the repair of the wound. We hope to see this same biologic activity when the patch is placed onto ischemic tissue on the heart," Siani-Rose said.

"While the primary focus in this Phase I trial is to demonstrate the safety of Anginera, we hope to demonstrate in this and future trials that Anginera's biologic activity can promote the formation of structurally and functionally significant blood vessels in diseased cardiac tissue," said Gary Gentzkow, M.D., Chief Medical Officer for Theregen. "This potential, positive re-modeling effect of Anginera may increase blood flow and therefore improve the function of a patient's diseased heart. If proven safe and effective in future trials, this potential therapy could represent a significant advantage in the treatment of diffuse small vessel disease," said Dr. Gentzkow.

Theregen believes Anginera has broad therapeutic potential, especially in cardiac conditions where diffuse small vessel disease, such as coronary microvascular syndrome, is involved. A recent major study notes that as many as three million women in the United States may suffer from currently undiagnosed, untreatable diffuse small vessel disease that could lead to serious, debilitating, even life-threatening cardiovascular events.

The company's initial therapeutic focus for Anginera is as an adjunct therapy in patients undergoing coronary artery bypass graft (CABG) surgery. In the United States about 150,000 patients who annually undergo CABG procedures also suffer from related diffuse small vessel heart disease, treatable by Anginera.

Theregen Corporation (www.theregencompany.com) develops cell-based therapies for patients with cardiac and peripheral vascular disease. Theregen's primary corporate objective is the clinical development and approval of Anginera(TM), its lead product candidate. Theregen is located in San Francisco, Calif., with research and development facilities in Tucson, Ariz.

Source: Business Wire

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