SOURCE: Lipid Sciences, Inc.

July 13, 2005 10:00 ET

Lipid Sciences Completes Data Analysis of Non-Human Primate Safety and Effectiveness Study

PLEASANTON, CA -- (MARKET WIRE) -- July 13, 2005 -- Lipid Sciences, Inc. (NASDAQ: LIPD)

--  Safety of HDL Therapy established in study animals
    
--  Encouraging plaque regression trend noted in small study population
    
--  Company on track to meet critical milestones for IDE
    submission/approval and human clinical trial launch Q4 2005/Q1 2006
    
Lipid Sciences, Inc. (NASDAQ: LIPD) announced today the completion of the data analysis phase of its HDL Therapy non-human primate safety and effectiveness study. The data showed the HDL Therapy process to be safe and well-tolerated within the study population of African green monkeys. The study animals were monitored before, during, and after each of 12 weekly infusions of plasma that was delipidated using the proprietary process and device developed by Lipid Sciences. The data included over 3,000 assays of blood chemistry and physiological variables, such as blood pressure, heart rate, temperature, and respiration rate, collected throughout the study. No significant changes in any of the monitored variables were noted during the course of the study.

This study was conducted at the Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina, in collaboration with Dr. Lawrence L. Rudel. Dr. Rudel is Professor of Pathology, Section of Comparative Medicine (Department of Pathology) and Professor of Biochemistry at Wake Forest University. The study involved 12 African green monkeys, a widely accepted primate model for human atherosclerosis. These animals had been on a high fat diet for 7 years. The animals were evaluated with intravascular ultrasound (IVUS) to establish a baseline of atheroma volume (plaque buildup) at the beginning of this study. A second IVUS was conducted at the conclusion of the sequence of 12 weekly infusions of delipidated plasma. That data was then analyzed at the Cleveland Clinic Foundation under the direction of Dr. Steven Nissen and his colleagues.

Dr. Steve Nissen, Director of the Cleveland Clinic Cardiovascular Coordinating Center, noted that "This was the first attempt to use IVUS to study an anti-atherosclerotic therapy in an animal population. There were only 12 animals in the study, too few to reach any conclusions about the efficacy of the therapy, but the effort will help develop the methodology necessary for future trials."

Lipid Sciences' HDL Therapy Platform is in development as a potential treatment for atherosclerosis, a disease of blood vessels, caused by the build-up of cholesterol-filled plaques in the coronary arteries. Dr. S. Lewis Meyer, President and Chief Executive Officer of Lipid Sciences, commented, "We are very pleased that the safety data gathered as a result of this study supports our position that the process of HDL Therapy is safe and well tolerated. This safety data is a critical component of our IDE submission to the FDA for review and approval prior to the planned initiation of a human clinical trial in Q4 2005/Q1 2006. In addition to the primary objective, the demonstration of safety, we noted an encouraging trend in the change in percent atheroma volume. However, the effect did not reach statistical significance because of the limited number of study animals."

For further information about Lipid Sciences' selective delipidation technology, please visit the Company's website: www.lipidsciences.com.

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 technologies are based on a unique patented process, known as delipidation, which selectively and rapidly removes lipids, such as cholesterol, from targeted lipoproteins or viruses circulating in blood plasma without disrupting the non-targeted plasma protein function. The Company's HDL Therapy Platform 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. If left untreated, these plaques are highly vulnerable to rupture and to blood clot formation, which can result in a fatal myocardial infarction (heart attack). 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' delipidation technology. The Company believes that removing the virus' protective lipid coating exposes otherwise hidden 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; 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

    Donald C. Weinberger
    Wolfe Axelrod Weinberger Associates, LLC
    212-370-4500
    Email Contact