SOURCE: Lipid Sciences, Inc.

December 07, 2006 08:30 ET

Lipid Sciences' HDL Selective Delipidation Procedures Well Tolerated in "First in Man" Clinical Trial

PLEASANTON, CA -- (MARKET WIRE) -- December 7, 2006 -- Lipid Sciences, Inc. (NASDAQ: LIPD) announced that ten patients have been enrolled into its "first in man" clinical trial. Seven patients have completed a series of seven procedures of plasma collection and re-infusion, and the procedures were well tolerated by all. The Company will continue to provide updates on patient tolerance and rate of enrollment as the trial progresses toward its conclusion.

Dr. S. Lewis Meyer, President and Chief Executive Officer, noted, "We are very pleased that the procedures in our human clinical trial continue to be well tolerated, and that the patients are complying with the stringent conditions of the trial protocol. The enrollment of ten patients is a significant milestone met." Dr. Meyer continued, "Each year, 1.8 million Americans are added to the total known cardiovascular disease patient population of 13.2 million in the United States. Lipid Sciences' HDL Selective Delipidation therapy is a systemic treatment designed to change the composition of the patient's own HDL and to prevent the rupture of vulnerable plaque to stop the patient's next heart attack or stroke. We believe that this systemic treatment for cardiovascular disease has the potential to impact a large number of patients with significant unmet clinical needs." Dr. Meyer continued, "Statistics show that three out of every four patients on statin therapy are still having a heart attack; additionally, of those who have had a heart attack, there is a twenty percent chance of having another event within 18 months. We believe that our HDL selective delipidation technology may be a major contributor to providing a reduction in that risk."

A total of 30 subjects will be recruited into the trial, "A Randomized Single-Blind Placebo Controlled Study to Evaluate the Safety of the Lipid Sciences' Plasma Delipidation System (PDS-2) in Subjects with Prior Acute Coronary Syndrome," which is being conducted at the Washington Hospital Center in Washington, D.C. The primary endpoint for this trial is to determine clinical safety and feasibility (patient recruitment, patient compliance, and analysis of data) in the targeted population of Acute Coronary Syndrome patients. The secondary objective is to assess methods of analysis of data collected by intravascular ultrasound (IVUS). Because this is a blinded trial, the Company will not be able to comment on the secondary objective -- the analysis of the IVUS variables to select effectiveness endpoints for a future study -- until the conclusion of this trial.

Dr. Ron Waksman, Associate Director, Division of Cardiology, at Washington Hospital Center, an internationally-recognized IVUS specialist and the Principal Investigator for the trial, expects that he will be able to present an initial qualitative assessment about the primary endpoint of the trial, which is safety, at CRT (Cardiovascular Revascularization Therapies) 2007 to be held in Washington, D.C., March 7-9, 2007.

Plasma Delipidation System - 2 (PDS-2)

The investigational device used in this trial, PDS-2, is designed to selectively remove cholesterol from the high-density lipoprotein (HDL) particle in human plasma. The Lipid Sciences device is composed of an automated processor, a sterile single-use disposable kit, and reagents. The PDS-2 device is not connected to the subject at any time. The treatment subject's 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.

Additional information about this trial and the HDL Selective Delipidation business model can be found on the Company's website, www.lipidsciences.com, at the Investor Relations tab with the heading Investor Relations Fact Sheet: Corporate Presentation.

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, influenza, and a broad range of animal health applications.

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; the significant losses we have incurred to date, and our expectation that we will incur substantial losses in the future; the failure of our technology to prove 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; our exposure to product liability claims; 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.

Contact Information

  • FOR FURTHER INFORMATION CONTACT:
    Deborah S. Lorenz
    Vice President, Investor Relations and
    Corporate Communications
    Lipid Sciences, Inc.
    925-249-4031
    Email Contact