Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
PRNewswire - November 29, 2004
In December 2003, the Company announced the completion of a series of successful studies in a mouse animal model. Those studies demonstrated readily detectable and highly reproducible, enhanced immunogenicity of a delipidated virus as compared to both live virus and chemically-inactivated virus. In the mouse studies the delipidated lentivirus (SIVmac 251-a surrogate for HIV) elicited a broader and more robust cellular and antibody response to a broad array of SIV antigens with ultra-low boost concentrations of delipidated virus and, importantly, without the aid of an adjuvant. With that important milestone met, the development program moved forward to a preliminary study of non-human primates as the next phase in the validation of Lipid Sciences' Viral Immunotherapy platform.
The results of that initial non-human primate study were recently reviewed by Lipid Sciences' Viral Advisory Board and Viral Immunotherapy research team. The results of this preliminary study validated the enhanced immune response observed in the mouse animal study and demonstrated that a delipidated virus elicits a unique immune response against viral epitopes that are distinct from those induced by untreated virus. The administration of delipidated viral protein was well tolerated by the subject animals.
With those positive preliminary results as a backdrop, Lipid Sciences has now initiated a follow-on study. This study is designed to extend and expand the evaluation of the unique immune response generated by lentiviruses (HIV and SIV -- a surrogate for HIV) that have been delipidated with Lipid Sciences' proprietary delipidation process. The study subjects include Indian Rhesus Macaque monkeys, a widely-accepted non-human primate model for viral diseases like HIV. The Lipid Sciences' proprietary delipidation process employed in the initial study used an extremely low dose of viral protein compared with that used in conventional vaccines. These findings demonstrate that the delipidated viral antigen is more efficiently recognized by the immune system than untreated virus. The ability to utilize ultra-small amounts of a patient's autologous circulating viral antigen, and generate readily detectible broad and virus-specific immune responses, that can potentially contribute to the control of viral replication, provides a unique approach that may lead to an effective treatment for chronic HIV infection. The goal of the Company's Viral Immunotherapy program is the development of a novel therapy for use in the treatment of patients infected with HIV and ultimately other lipid-enveloped viruses.
Lipid Sciences' Viral Immunotherapy platform is focused on lipid-enveloped viruses such as HIV, Hepatitis B and C, SARS Coronavirus, and West Nile. Through the Company's proprietary delipidation technology: the lipid envelope of the virus is removed, exposing and/or modifying novel and existing epitopes leading to the generation of immune responses to viral epitopes, that are not normally recognized by the immune system, and thus broadening the range of epitopes and effectiveness of the anti-viral immune response. This then should cause the immune system to be sufficiently stimulated to fight the disease in question. The objective of the Company's Viral Immunotherapy development program is a therapeutic treatment for HIV-infected patients, not a preventive vaccine.
Dr. S. Lewis Meyer, President and CEO of Lipid Sciences commented, "We are certainly excited about these encouraging results in our early non-human primate study. We are optimistic that the results of this expanded study will continue to demonstrate proof of concept that delipidated virus stimulates a unique immune response as compared to live virus and has the potential to be the basis of an innovative treatment for HIV-infected patients. A successful study outcome would bring us one step closer to being able to provide a therapeutic treatment for this disease and have a significant impact on what many consider one of the most challenging healthcare issues today. Recent data published by UNAIDS shows that the number of people living with HIV is approximately 38 million worldwide, that five million people were newly infected with HIV, and 3 million people died as a result of AIDS in 2003." He continued, "These exciting results generated by our Viral Immunotherapy development program follow our recent (September 23) launch of a safety and efficacy study in non-human primates for our HDL Therapy delipidation technology and process. We believe that these strong scientific results validate the Company's aggressive pursuit of these two technology platforms in parallel."
Lipid Sciences announced on May 3, 2004 that data reviewed by its Scientific Advisory Board established that the Company's HDL Therapy system can selectively remove lipids from HDL creating a modified form of HDL that is known to be more effective in reverse cholesterol transport-the body's natural process for removing lipids from arterial plaque. The results of the proof of concept study were presented at a Scientific Session of the annual meeting of the American Heart Association earlier this month. With these findings as a basis, the Company initiated a non-human primate study on September 23, 2004.
This study is being conducted at Wake Forest University Baptist Medical Center under the direction of Dr. Lawrence L. Rudel. This pre-clinical animal study is designed to demonstrate the safety and efficacy of this HDL Therapy system in a relevant human-like model. The endpoint of this study will be the measurement of arterial plaque regression as determined by comparing plaque volume by intravascular ultrasound (IVUS) at the beginning and at the end of the treatment cycle. Analysis of this data will occur under the direction of Dr. Steven E. Nissen at the Cleveland Clinic Foundation. This animal study is scheduled to be completed in the second quarter of 2005.
Background on members of Lipid Sciences' Viral Advisory Board
Aftab A. Ansari, Ph.D. is Professor, Department of Pathology and Laboratory Medicine, Emory University and Research Professor, Yerkes Regional Primate Center, positions he has held since 1985. Dr. Ansari's research has been focused in the areas of immunology and HIV/AIDS. James E.K. Hildreth, M.D., Ph.D., Professor of Pharmacology and Molecular Sciences, and of Pathology at Johns Hopkins University School of Medicine. Dr. Hildreth's research has been focused on the role of lipid rafts, adhesion molecules, and the exosome release pathway in the biology of human retroviruses (HIV).
Susan B. Zolla-Pazner, Ph.D., is a tenured professor of Pathology at New York University (NYU). She is the Director of the AIDS International Training and Research Program at NYU and Director of the Immunology Core Laboratory of the NYU Center for AIDS Research. She is also the Director of the Research Enhancement Award Program of the New York Veterans' Affairs Medical Center. Dr. Zolla-Pazner's research has been in the areas of HIV vaccines and human monoclonal antibody production.
Please Note: Funding for the study described in this press release was provided by Lipid Sciences, Inc. Drs. Ansari, Hildreth, and Zolla-Pazner are remunerated and have been granted stock options as members of the Viral Advisory Board.
Lipid Sciences, Inc. is a development-stage biotechnology company engaged in the research and development of products and processes 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 removes lipids from targeted proteins. 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 envelope from certain viruses and other lipid-containing infectious agents by application of its delipidation technology. The Company believes that removing the infectious agent's protective lipid envelope exposes otherwise hidden viral proteins, thereby stimulating the body's immune system to elicit an enhanced response to the infectious agent. Conditions that could potentially be impacted by this technology include HIV, Hepatitis B and Hepatitis C, West Nile and SARS.
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 or attract strategic partners or to effect other transactions; 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; our reliance on collaborations with strategic partners; competition in our industry; failure to secure and enforce our intellectual property rights; risks associated with use of biological and hazardous materials; product liability claims; and our dependence on key personnel. The financial information contained in 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.
Press releases for Lipid Sciences, Inc. are available on our website: http://www.lipidsciences.com . If you would like to receive our press releases via email, please contact: info@lipidsciences.com.
SOURCE Lipid Sciences, Inc.
Web Site: http://www.lipidsciences.com
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PR041148
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