News Releases

Initial Clinical Trial Experience Encouraging for Comination of Liprostin™ and Angioplasty

Memorial Hermann Hospital physicians lead investigative effort in new approach to treating critical limb ischemia

Houston, Texas, June 13, 2003 – Richard Smalling, M.D., Ph.D., medical director of the cardiac catheterization lab at Memorial Hermann Hospital and chairman of the Division of Cardiology, The University of Texas Medical School at Houston, today announced successful performance of the first angioplasty case with the investigational drug LiprostinTM (liposomal prostaglandin E1) for a patient suffering from a totally blocked artery in a lower limb.

Dr. Smalling is a Co-Investigator for the Phase II, open label trial that is being conducted exclusively at Memorial Hermann Hospital.

The trial is authorized under a treatment Investigational New Drug (IND) protocol. The U.S. Food and Drug Administration (FDA) allows an investigational drug to be used under a treatment IND if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population. In this trial, Liprostin is being studied as adjunct therapy with angioplasty for patients with peripheral artery occlusive disease. Liprostin exhibits potent vasodilator and anti-inflammatory properties. Dr. Smalling and his associate, Satyendra Giri, M.D., are researching its ability to prevent blood clots during and after angioplasty.

The procedure was performed on a 50-year-old woman who suffered from extensive pain and a non-healing leg ulcer that prevented her from meeting her job requirements. Following the procedure and use of Liprostin, the patient was released from the hospital the next day.

“This patient’s case was challenging, but she made an excellent recovery,” said Dr. Smalling. “Immediately after the procedure, her pulses were restored in her foot and the following day she felt her leg ulcer had already started to heal. Our hope is that many patients with this condition will be able to benefit from the combination of Liprostin and angioplasty, and thus can avoid invasive surgery.”

In this trial, Liprostin is given as an intra-arterial bolus injection, followed by angioplasty, followed by a 12-hour intravenous infusion of the study drug. The primary endpoint of the study is increased walking distance or pain-free walking distance measured on a treadmill. The trial is designed to treat 12 patients, and Dr. Giri, the Principal Investigator, expects to complete the trial by December 2003.
For more information about the trial, contact Catharine Carter at 713-500-6550.

Memorial Hermann, a not-for-profit health care system, provides quality comprehensive programs and services for a person’s whole life. Through its 11 hospitals located in the Texas Medical Center and the greater Houston area, Memorial Hermann offers the convenience of health care in neighborhoods where people live and work, as well as easy access to the resources and technology of a of a university-affiliated teaching hospital, which was featured on the ABC-TV series Houston Medical. Memorial Hermann takes a holistic approach to health care, offering programs and services that address the physical, social, psychological and spiritual aspects of wellbeing. Employees, volunteers and medical staff partners take pride in delivering care with compassion and respect.

Editor’s note: Liprostin is produced by Endovasc Inc. of Montgomery, Texas. Endovasc is the sponsor of this clinical trial.

For more information, contact Media Relations.