Lipid Sciences seeks FDA OK to begin human trial of lipid removal system

By Angela McDaniels

Seattle, Dec. 29 - Lipid Sciences Inc. has filed an Investigational Device Exemption application with the Food and Drug Administration to begin a human trial of the company's Plasma Delipidation System-2, according to an 8-K report filed with the Securities and Exchange Commission.

The proposed randomized, placebo-controlled trial will include 30 subjects between the ages of 18 and 75 who have previously been treated for acute coronary syndrome and have angiographic evidence of coronary heart disease.

Half of the subjects will receive a re-infusion of their own plasma delipidated by the PDS-2. The other half will receive a re-infusion of their untreated plasma.

The primary clinical endpoint is safety. A secondary objective is to assess the methods of analysis for data collected by intravascular ultrasound, such as segment plaque volume and plaque thickness. These variables will be analyzed and employed to select effectiveness endpoints for a future study, according to the filing.

The 10-week trial is to be conducted at the Washington Hospital Center in Washington, D.C.

Lipid Sciences is a development-stage biotechnology company based in Pleasanton, Calif., that researches and develops products and processes to treat major medical indications in which lipids or fat components play a key role.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.