Intravascular Ultrasound Demonstrates Utility in Evaluating Drug
Efficacy; Dr. H. Bryan Brewer, Jr. Sees Enormous Potential for HDL
PLEASANTON, CA, Mar 30, 2007 (MARKET WIRE via COMTEX News Network) -- Lipid Sciences, Inc. (NASDAQ: LIPD) Dr. H. Bryan Brewer, Jr., Chief Scientific Director of Lipid Sciences, Inc., concluded from the wide range of presentations at the recent American College of Cardiology (ACC) Meeting in New Orleans that the rationale for HDL being the next, most logical target for the development of treatments for cardiovascular disease continues to exhibit enormous potential. This conclusion is even more compelling in light of the recent, highly publicized failure of the CETP inhibitor, torcetrapib.
This week at the ACC meeting, the latest data on three imaging trials, which included an intravascular ultrasound (IVUS) study, with Pfizer's HDL raising drug, torcetrapib were presented. Torcetrapib is a member of a class of drugs which increase HDL by inhibiting the cholesterol ester transfer protein (CETP). ILLUMINATE, a morbidity and mortality trial comparing the clinical efficacy and safety of torcetrapib/atorvastatin (Lipitor) versus atorvastatin alone was terminated in December 2006 due to an increased number of deaths in those patients taking torcetrapib/atorvastatin. It is important to note that the three imaging trials also failed to show a benefit of torcetrapib/atorvastatin when compared to atorvastatin alone and were consistent with the lack of efficacy that was observed.
Dr. Brewer noted, "The results obtained in the ILLUMINATE trial and the three imaging trials, while unexpected, do not reflect on the potential clinical benefit of raising HDL. Statin drugs have a proven clinical benefit in reducing heart attacks and stroke; however, the reduction in these clinical events is, at best, only approximately one third. A significant number of patien ts taking statins continue to have clinical events, and increasing HDL has been widely accepted as a potential major new approach in reducing the residual risk of a heart attack or stroke in high-risk patients taking statin drugs. The results obtained with the imaging techniques, including IVUS, clearly indicate that imaging trials can be an effective way to obtain and assess data which can be useful in determining the potential of new HDL therapies. Existing epidemiological data and pre-clinical animal studies continue to provide us with overwhelming evidence that higher levels of HDL, or increasing the functionality of existing HDL, will result in reduced cardiovascular disease. Twenty years after the introduction of statins, HDL therapy is clearly now the new frontier. The field is wide open to pursue innovative solutions focused on HDL therapy, and the unmet clinical need is clear."
In a recent study report in the March 26, 2007 issue of The New England Journal of Medicine, Dr. John J.P. Kastelein, Academic Medical Centre, University of Amsterdam, and member of the Lipid Sciences' Scientific Advisory Board noted, that even with the most aggressive treatment, (statin) drugs reduce the risk of a major coronary event by only 30%. This finding, combined with a projection that mortality from cardiovascular causes will increase worldwide by 90% by the year 2020, as compared with that in 1990, illustrates the need for new efficacious treatments for cardiovascular disease.
Furthermore, as an industry expert, Dr. Brewer was recently featured in a Medscape interview, "Raising High-Density Lipoprotein Cholesterol: What Are We Learning From the Torcetrapib Experience?" providing perspective on the current state of HDL Therapy and its future potential. The full text of the article will be available on our website: www.lipidsciences.com at the Lipid Sciences in the News heading.
Lipid Sciences' HDL Therapy platform (HDL Selective Delipidation and HDL Mimetic Peptides) aims to develop treatments to reverse atherosclerosis, a disease of 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). Our HDL Therapy platform increases the functionality of existing HDL in a patient not simply the quantity of HDL. We are currently in a "first in man" clinical trial at the Washington Hospital Center (Washington, D.C.) to evaluate the safety and feasibility of our Plasma Delipidation System (PDS-2) in subjects with prior Acute Coronary Syndrome. A secondary objective of this trial is to assess methods of analysis of data collected by IVUS. Measurements of segment plaque volume, percentage atheroma volume, plaque thickness, discrete lesion analysis, and other IVUS variables will be analyzed and employed to select effectiveness endpoints for a future study. The IVUS analysis will be conducted at two core IVUS laboratories: at the Cardiovascular Research Institute at the Washington Hospital Center by Dr. Neil Weissman, Director of the Cardiac Ultrasound and Ultrasound Core Laboratories, and at Stanford University Medical Center by Dr. Peter J. Fitzgerald, Director of the Center for Research in Cardiovascular Interventions and the Cardiovascular Core Analysis Laboratory. We expect to complete this trial during the second half of 2007 and start an effectiveness trial in early 2008.
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 Selective Delipidation and HDL Mimetic Peptides) aims to develop treatments to rever se 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, West Nile, SARS, influenza, 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 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; the significant losses we have incurred to date, and our expectation that we will incur substantial losses in the future; the failure of o ur technology to prove 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; acceptance of our potential products by healthcare providers and patients; our exposure to product liability claims; 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.
FOR FURTHER INFORMATION CONTACT:
Deborah S. Lorenz
Vice President, Investor Relations and
Lipid Sciences, Inc.
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SOURCE: Lipid Sciences, Inc.