Lipid Sciences to begin trial of cholesterol removal system

By Angela McDaniels

Seattle, Jan. 31 - Lipid Sciences Inc. said it has received conditional approval from the Food and Drug Administration to begin a human clinical trial of the company's Plasma Delipidation System-2 (PDS-2) in patients who have been treated for acute coronary syndrome.

The company filed an Investigational Device Exemption application seeking permission to begin the trial with the FDA on Dec. 29. Lipid Sciences has been granted approval on the condition that it submit a response to questions raised and observations made by the FDA within 45 days, according to a company news release.

The proposed randomized, single-blind, placebo-controlled trial is to be conducted at the Washington Hospital Center in Washington, D.C. and will likely begin in the first quarter of 2006.

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 own untreated plasma that has not been delipidated as the control arm of the study. The study duration will be about 10 weeks for each subject.

The company said that because this is not considered a pivotal study, the primary clinical endpoint will be safety.

A secondary objective of the study is to assess the methods of analysis for data collected by intravascular ultrasound. Measurements of segment plaque volume, percentage atheroma volume, plaque thickness and other intravascular ultrasound variables will be analyzed and employed to select effectiveness endpoints for a future study.

The PDS-2 is designed to selectively remove cholesterol from the high-density lipoprotein particle in human plasma. The device is comprised of automated hardware, a sterile single-use disposable kit and reagents, the company said. The PDS-2 is not connected to the subject at any time: the subject's plasma is instead treated offline with the reagents, pumped into a transfer pack and then re-infused into the subject via a separate infusion pump after processing.

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