Lipid Sciences' Autologous Therapeutic HIV Vaccine Study Published In "Experimental Biology And Medicine"

Main Category: HIV / AIDS
Also Included In: Immune System / Vaccines
Article Date: 10 Jun 2008 - 5:00 PDT

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Lipid Sciences, Inc. (NASDAQ: LIPD) announced that the results of a proof-of-concept study that demonstrated a positive therapeutic effect with the Company's proprietary autologous virus vaccine in SIV-infected non-human primates was published in an original research article entitled, "Delipidated Retroviruses as Potential Autologous Therapeutic Vaccines -- A Pilot Experiment." The article appeared in Experimental Biology and Medicine (233:732-740,2008). The abstract and article are available on the Company's website: http://www.lipidsciences.com under the heading Scientific Abstracts and Publications.

This pilot experiment consisted of four animals that were long-term ( > 1 year) chronically infected with Simian Immunodeficiency Virus (SIV) -- a widely-accepted model for HIV. At the initiation of the study, the animals were severely immune-compromised and experiencing typical symptoms of AIDS. Vaccination with autologous SIV, delipidated by Lipid Sciences' proprietary process, led to an average 8.6 times viral load reduction in the treated animals. The viral load change, pre- versus post-vaccination, was statistically significant (p < 0.001), indicating the strong benefit of autologous delipidated viral vaccination in lowering viral loads in chronically-infected animals. Furthermore, the vaccinated animals had a significant (p < 0.006) enhancement of survival when compared to a set of historical control animals. The animals also exhibited fewer symptoms of AIDS post-vaccination. These findings reaffirm the benefit of therapeutic vaccination, even in animals which are long-term chronically infected and severely immune-compromised. These findings have implication for the use of therapeutic vaccines in patients who are long-term chronically infected with HIV.

S. Lewis Meyer, Ph.D., President and Chief Executive Officer of Lipid Sciences, commented, "It is important to note that in a follow-up placebo-controlled study with early chronically-infected animals, the Company has further demonstrated a significant viral load reduction, pre- versus post-vaccination, in treated animals (p=0.03). These results, especially when viewed in the context of the recent, highly publicized failure of a large-scale HIV vaccine trial, clearly point the way to a new and novel avenue of HIV vaccine development. We are pursuing grant funding from a variety of governmental and private sources to move our HIV vaccine development program forward.

This pre-clinical study was conducted at the Yerkes National Primate Research Center at Emory University in Atlanta, under the direction of investigators including Dr. Aftab A. Ansari, Professor, Department of Pathology, Emory University School of Medicine; Dr. James E.K. Hildreth, Director, Center for AIDS Health Disparities Research, Meharry Medical College; and Dr. Francois Villinger, Professor, Department of Pathology, Emory University School of Medicine. Dr. Moiz Kitabwalla, Senior Manager of Viral Programs for Lipid Sciences acted as a co-investigator and as the coordinator for this study. Dr. Kitabwalla is the principal author of this article.

Lipid Sciences' Viral Immunotherapy is a broadly applicable platform technology that focuses on the removal of the lipid coatings from lipid-enveloped viruses utilizing the Company's proprietary delipidation technologies. In addition to HIV, conditions that could potentially be affected by these technologies include SARS and influenza. Lipid Sciences believes its Viral Immunotherapy platform also has applicability to a wide range of viruses impacting animal health -- a diverse market with diseases affecting both food and companion animals. In late 2006 Lipid Sciences entered into a collaborative research and license agreement with Elanco Animal Health, a division of Eli Lilly and Company, to address these animal health markets.

About Experimental Biology and Medicine (EBM)

Experimental Biology and Medicine is a journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. Articles in EBM represent cutting edge research at the overlapping junctions of the biological, physical and engineering sciences that impact upon the health and welfare of the world's population.

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 Mimetic Peptides and HDL Selective Delipidation) aims to develop treatments to reverse atherosclerosis, a systemic disease 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 focuses on the removal of the lipid coatings from lipid-enveloped viruses and other lipid-containing infectious agents by applying Lipid Sciences' proprietary delipidation technologies. 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 these technologies include HIV, SARS, and influenza. In addition, Lipid Sciences believes that this Viral Immunotherapy platform also has applicability to a wide range of viruses impacting animal health -- a diverse market with diseases affecting both food and companion animals.

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 should refer 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 technologies not proving to be safe or effective; our inability to obtain regulatory approval of our technologies, which are 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; our reliance on key suppliers to provide the material necessary to conduct successful pre-clinical and clinical studies; 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 http://www.sec.gov. Lipid Sciences assumes no obligation to update the forward-looking statements included in this document.

http://www.lipidsciences.com