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Lipid Sciences, Inc. Receives Approval to Begin Human Clinical Trial From the Institutional Review Board of Medstar Research Institute

Posted on: Thursday, 20 April 2006, 09:01 CDT

Lipid Sciences, Inc. (NASDAQ: LIPD) today announced that the Company had received notification from the Institutional Review Board (IRB) of Medstar Research Institute that approval had been given to begin a human clinical trial of Lipid Sciences' Plasma Delipidation System-2 (PDS-2). With this approval, all conditions set by the FDA earlier this year have now been met for the initiation of the trial.

This human clinical trial titled, "A Randomized Single-Blind, Placebo Controlled Study to Evaluate the Safety of the Lipid Sciences PDS-2 in Subjects with Acute Coronary Syndrome" will be conducted at the Washington Hospital Center (WHC) in Washington, D.C. WHC is one of the world's largest cardiac catheterization laboratories performing over 19,000 procedures in the last year, offering a large potential population of patients suitable for inclusion in this study. WHC also has long-standing experience in conducting human clinical trials -- participating in 30-50 investigational trials at any given time. Dr. Ron Waksman, Associate Director, Division of Cardiology, at Washington Hospital Center, and an internationally recognized intravascular ultrasound (IVUS) specialist, will be the principal investigator for the trial.

The primary endpoint for this trial is clinical safety and feasibility (patient recruitment, patient compliance, and analysis of data) in the targeted patient population. The secondary objective is to assess methods of analysis of data collected by IVUS. Measurements of segment plaque volume, percentage atheroma volume, plaque thickness, discrete lesion analysis, and other IVUS variables will be analyzed and employed to select effectiveness endpoints for a future study. The IVUS analysis will be conducted at two core laboratories: at the Cardiovascular Research Institute at the WHC by Dr. Neil J. Weissman, Director of the Cardiac Ultrasound and Ultrasound Core Laboratories, and at Stanford University Medical Center by Dr. Peter J. Fitzgerald, Director of the Center for Research in Cardiovascular Interventions and the Cardiovascular Core Analysis Laboratory.

The subjects of the trial will be 30 male and female patients between 18 and 75 years of age with angiographic evidence of Coronary Artery Disease in the target artery as defined by at least 1 lesion with an occlusion between 20-50%. An IVUS assessment will be made before inclusion into the trial and at the conclusion of 7 weekly delipidation/re-infusion treatments. The treatment subjects will receive infusions of plasma that has been delipidated by the PDS-2 system; the control subjects will receive infusions of their own untreated plasma that has not been delipidated. Including the screening, treatment and post treatment analysis, the study duration for each subject will be approximately 10 weeks. It is expected that the total study will conclude by the end of the year.

The investigational device, the PDS-2, is designed to selectively remove cholesterol from the high-density lipoprotein (HDL) particle in human plasma. The device is composed of an automated processor, sterile single-use disposable kit, and reagents. The PDS-2 device is not connected to the subject at any time. The treatment subjects' plasma is processed offline with Lipid Sciences' LSI-S955 proprietary reagent mixture, pumped into a transfer pack, and then re-infused back into the subject via a separate infusion pump after processing. All subjects in the trial are monitored (including vital signs, complete blood count, lipoprotein profile, etc.) before and throughout the process.

Dr. S. Lewis Meyer, President and Chief Executive Officer of Lipid Sciences, commented, "The final elements of preparation for this trial are now complete. The PDS-2 systems are in place at the Washington Hospital Center and have been validated; the clinical trial support personnel are in place and have been trained. Now that we have received approval from the Institutional Review Board of the Medstar Research Institute, we can begin our planned process of validating every step of the human trial protocol in preparation for the recruitment of the trial subjects. We anticipate patient recruitment will begin the week of May 8th."

Lipid Sciences, Inc. is a development-stage biotechnology company engaged in the research and development of products and processes intended to treat major medical indications, in which lipids, or fat components, play a key role. The Company's HDL Therapy platform (HDL Selective Delipidation and HDL mimetic peptides) is aimed at developing treatments for the reversal of atherosclerosis, a systemic disease of the blood vessels caused by the build-up of cholesterol-filled plaques in the vascular system and, most critically, in the coronary arteries. Regression of such plaques may have a major impact on reducing the risk of acute coronary events. The Company's Viral Immunotherapy platform is focused on the removal of the lipid coatings from lipid-enveloped viruses and other lipid-containing infectious agents by application of Lipid Sciences' proprietary delipidation technology. The Company believes that removing the virus' protective lipid coating enhances the processing and presentation of viral proteins to stimulate the body's immune system to effectively fight the disease. Conditions that could potentially be impacted by this technology include HIV, Hepatitis B and Hepatitis C, West Nile, SARS and influenza.

Forward-Looking Statements: This release contains forward-looking statements concerning plans, objectives, goals, strategies, study results, anticipations, expectations, future events or performance as well as all other statements that are not statements of historical fact. The forward-looking statements contained in this release reflect our current beliefs and expectations on the date of this release. Actual results, performance or outcomes may differ materially from what is expressed in the forward-looking statements. Readers are referred to the documents filed by us with the SEC, specifically the most recent reports on Form 10-K and Form 10-Q which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements. In addition to those risk factors, other factors that could cause actual results to differ materially include the following: Our inability to obtain adequate funds; our technology not proving to be safe or effective; our inability to obtain regulatory approval for our technology, which is only in the clinical development stage; delay or failure to complete clinical studies; our dependence on our license agreement with Aruba International B.V.; our reliance on collaborations with strategic partners and consultants; competition in our industry, including the development of new products by others that may provide alternative or better therapies; failure to secure and enforce our intellectual property rights; risks associated with use of biological and hazardous materials; acceptance of our potential products by healthcare providers and patients; and our dependence on key personnel.

This release should be read in conjunction with the consolidated financial statements and notes thereto included in our most recent reports on Form 10-K and Form 10-Q. Copies are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov. Lipid Sciences assumes no obligation to update the forward-looking statements included in this document.

Press releases for Lipid Sciences, Inc. are available on our website: www.lipidsciences.com. If you would like to receive our press releases via email, please contact: info @lipidsciences.com.

 FOR FURTHER INFORMATION CONTACT: Deborah S. Lorenz Vice President, Investor Relations and Corporate Communications Lipid Sciences, Inc. 925-249-4031 Contact via http://www.marketwire.com/mw/emailprcntct?id=6C22F217F539EEB5  Wolfe Axelrod Weinberger Associates, LLC Donald C. Weinberger Contact via http://www.marketwire.com/mw/emailprcntct?id=57F721A6B4BA00EC  Media: Alisa Steinberg Contact via http://www.marketwire.com/mw/emailprcntct?id=459C9CF0FB4C6F5E 212-370-4500  

SOURCE: Lipid Sciences, Inc.

Source: MARKET WIRE

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