SOURCE: Lipid Sciences, Inc.

September 09, 2005 08:30 ET

Lipid Sciences, Inc. Completes Study in SIV-Infected Non-Human Primates

Significant Viral Load Reduction and Dramatic Survival Rate Are Key Findings

Expanded Follow-On Study to Begin Before the End of 2005

PLEASANTON, CA -- (MARKET WIRE) -- September 9, 2005 -- Lipid Sciences, Inc. (NASDAQ: LIPD) announced today that it has completed its exploratory investigation of the therapeutic effect of delipidated autologous virus in chronically SIV-infected rhesus macaques. Simian Immunodeficiency Virus (SIV) is a widely accepted primate model for viral diseases like HIV.

The results of this study, conducted at the Yerkes National Primate Research Center at Emory University, demonstrated that the administration of "autologous" SIV viral antigen delipidated by Lipid Sciences' proprietary delipidation process to chronically SIV-infected non-human primates led to the recognition of new epitopes of the virus by the animals' immune system which was coincident with an improvement in the general indicators of overall health in these study animals. Statistical significance was reached both in the long-term survival of these animals as compared to a retrospective, SIV-infected, non-immunized control group (p=0.0067), as well as a viral load reduction of approximately 90% (p=0.04), that was achieved for the nine months' duration of the study follow-up period. This study was conducted under the direction of Aftab A. Ansari, Ph.D. Professor, Department of Pathology and Laboratory Medicine, Emory University. Dr. Ansari is a member of Lipid Sciences' Viral Advisory Board.

Dr. Ansari noted, "The response of these animals has been phenomenal. The ability to use extremely small amounts of an animal's autologous circulating viral antigen to generate a virus-specific neo-immune response that can potentially lead to the control of viral replication, provides a unique approach to the development of an effective treatment for chronic HIV infection. These low viral doses are causing results significant enough for us to continue with an expanded study."

S. Lewis Meyer, President and Chief Executive Officer of Lipid Sciences, Inc., commented, "We are so encouraged by this study data that we are moving forward with a much larger, controlled study to demonstrate both survival and viral load reduction in a statistically significant group of SIV-infected non-human primates. We expect that this expanded study, which will also be conducted at Emory University, will commence before year-end 2005. It is anticipated that this study will provide a strong base of safety data that can be used as the basis of an offshore human study or a future application to the Food and Drug Administration to allow us to move to a human clinical trial designed for the treatment of HIV-infected patients."

Dr. James E.K. Hildreth, Director of the Center for Health Disparities Research in HIV, Professor of Medicine at Meharry Medical College, Adjunct Professor of Pharmacology at Johns Hopkins Medical School, and member of Lipid Sciences' Viral Advisory Board, performed the analysis of the anti-viral antibody titers throughout this study. Dr. Hildreth observed, "I am enthusiastic about moving ahead with a larger, controlled study in order to validate the results of this small study. I believe that the results from these animals are truly remarkable and, to my knowledge, have not been seen before in other therapeutic vaccine studies. The survival data alone is very powerful even without the viral load reduction."

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 (selective HDL 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 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