Lipid Sciences Announces Positive HIV Program Results
Non-Human Primates Respond Well to Therapeutic Treatment in
PLEASANTON, CA, Jan 28, 2008 (MARKET WIRE via COMTEX News Network) -- Lipid Sciences, Inc. (NASDAQ: LIPD) announced today that it had demonstrated a positive therapeutic effect with the Company's proprietary delipidated autologous virus vaccine in SIV-infected non-human primates. Primates infected with Simian Immunodeficiency Virus (SIV) are a widely-accepted model for HIV. Twelve animals ultimately qualified for this 22-month study -- 6 animals in the treatment arm and 6 placebo animals. Vaccination with autologous SIV, delipidated by Lipid Sciences' proprietary process, led to an average 15.5 times viral load reduction in the treated animals. All 6 animals in the treatment arm of the study responded with drops in viral load in excess of 90%. While the study was not powered for statistical significance, it revealed an extremely strong trend of p=0.1, indicating the strong benefit of autologous delipidated viral vaccination in lowering viral loads in chronically-infected animals.
This pre-clinical Safety and Effectiveness 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, Comprehensive Center for Health Disparities Research and HIV, 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. James E.K. Hildreth commented on behalf of the study group, "The results of this study are terribly exciting and re-confirm an earlier outcome seen in a smaller group of immune-compromised animals. A viral load reduction in excess of 90%, to my knowledge, has never been seen before in other therapeutic vaccine studies. This treatment has the potential of introducing a whole new way of containing the pandemic of HIV."
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 Hepatitis B and Hepatitis C. Lipid Sciences believes its Viral Immunotherapy platform also has applicability to 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.
Dr. S. Lewis Meyer, President and Chief Executive Officer of Lipid Sciences, commented, "The positive results of this study substantiate our conclusion that our Viral Immunotherapy technology platform has a strong potential to develop both an effective therapeutic treatment as well as a prophylactic vaccine against HIV. To that end, the Company has submitted a grant application to the National Institutes of Health for the development of a preventive vaccine for HIV. If awarded, this grant will fund in vitro and pre-clinical studies to demonstrate 'proof of concept' for our preventive HIV vaccine."
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 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 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, Hepatitis B and Hepatitis C, 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 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; the significant losses we have incurred to date, and our expectation that we will incur substantial losses in the future; the failure of our technologies to prove safe or effective; our inability to obtain regulatory approval for our technologies, which are only in the clinical development stage; delay or failure to complete pre-clinical animal studies or clinical trials; 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.
Posted: January 2008