Endovasc Set to Begin Clinical Trials with Liprostin

Endovasc Ltd. Inc. (Montgomery, TX) taken the final step necessary to initiate clinical trials for its new drug Liprostin. The company announced that its contract manufacturer, Collaborative BioAlliance Inc. (Stony Brook, NY), has received certified Chemistry, Manufacturing and Controls (CMC), which completes Endovasc's Investigational New Drug (IND) application requirements for the FDA. Collaborative completed the pilot phase of production in September 1999, and current good manufacturing practices (cGMP) in February 2000.

Liprostin (prostaglandin E1) is a natural occurring hormone that acts as a vasodilator, opening blocked blood vessels to improve circulation. The drug is encapsulated in liposomes (fat molecules) for delivery, which extends its release.

In the clinical studies, Liprostin will first be used to treat patients with poor or blocked blood circulation in the extremities who are faced with amputation, a condition called critical limb ischemia (CLI). But that is just the "tip of the iceberg" for Liprostin, according to Endovasc chairman and CEO David P. Summers.

"Although the market is $300 million, the follow-on markets for coronary and peripheral restenosis, salvage of heart tissue after heart attack (called myocardial infarct salvage), and liver disease give Liprostin a billion dollar potential," Summers said.

Endovasc Ltd. Inc. is a biopharmaceutical company using liposomal drug delivery for products that have already shown safety and efficacy in generic form, and other products for increased circulation in limbs and to the heart.

For more information: Barbara Richardson, Endovasc Ltd. Inc., 15001 Walden Rd., Suite 108, Montgomery, TX 77356. Tel: 936-448-2222. Fax: 936-582-2250. Email: bjr@endovasc.com.

Edited by Jim Pomager