Healthcare Industry News: Acute Coronary Syndrome
News Release - June 1, 2006
Lipid Sciences, Inc. Initiates Human Clinical Trial of Plasma Delipidation SystemFirst Patient Procedure Complete
PLEASANTON, CA--(Healthcare Sales & Marketing Network)--Jun 1, 2006 -- Lipid Sciences, Inc. (NasdaqNM:LIPD ) announced today that the first patient procedure has been completed in the Company's human clinical trial: "A Randomized Single-Blind, Placebo Controlled Study to Evaluate the Safety of the Lipid Sciences' Plasma Delipidation System-2 (PDS-2) in Subjects with Prior Acute Coronary Syndrome." The trial is being conducted at the Washington Hospital Center (WHC) in Washington, D.C. Dr. Ron Waksman, Associate Director, Division of Cardiology, at Washington Hospital Center, and an internationally recognized intravascular ultrasound (IVUS) specialist, is the principal investigator for the trial.
Thirty subjects between the ages of 18 and 75 with angiographic evidence of Coronary Artery Disease in the target artery, as defined by at least one lesion with an occlusion between 20-50%, will be recruited into the trial. Each potential participant will undergo an initial screening, which includes a blood panel and IVUS assessment to determine eligibility for enrollment and randomization into the study. The trial will consist of a total of 7 weekly delipidation/re-infusion procedures. The treatment subjects will receive infusions of plasma that has been delipidated by the PDS-2 system; the control subjects will receive infusions of their own untreated plasma that has not been delipidated. An IVUS assessment of the participants will also be made at the conclusion of the trial. The study duration for each participant will be approximately 10 weeks. Since enrollment into the trial will be staggered, it is expected that the total study will conclude by the end of this year.
The primary endpoint for this trial is clinical safety and feasibility (patient recruitment, patient compliance, and analysis of data) in the targeted patient population. The secondary objective 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 catheterization laboratories: at the Cardiovascular Research Institute at the Washington Hospital Center by Dr. Neil J. 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.
The investigational device, the PDS-2, is designed to selectively remove cholesterol from the high-density lipoprotein (HDL) particle in human plasma. The device is composed of an automated processor, a sterile single-use disposable kit, and reagents. The PDS-2 device is not connected to the subject at any time. The treatment subjects' plasma is processed offline with Lipid Sciences' LSI-S955 proprietary reagent mixture, pumped into a transfer pack, and then re-infused back into the subject via a separate infusion pump after processing. All subjects in the trial are monitored (including vital signs, complete blood count, lipoprotein profile, etc.) before and throughout the process.
Dr. S. Lewis Meyer, President and Chief Executive Officer of Lipid Sciences, commented, "Moving into a clinical trial setting with our innovative HDL Selective Delipidation process is a transforming step forward for Lipid Sciences. We are very fortunate to be able to partner with Washington Hospital Center (WHC) as we launch this trial of our systemic HDL therapy in the battle against cardiovascular disease. WHC is one of the world's largest cardiac catheterization laboratories performing over 19,000 procedures in the last year. Because of our very comprehensive inclusion/exclusion criteria for this 'first in man' trial, WHC offers us access to an ideal population of patients suitable for participation in this study."
Dr. Meyer continued, "As this trial progresses it is our intention to provide updates on patient enrollment and an indication of how the process is being tolerated by the patients -- with safety being the primary endpoint of the trial. Because this is a blinded trial, we will not be able to comment on the secondary objective -- the analysis of IVUS variables to select effectiveness endpoints for a future study -- until the conclusion of the trial."
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) 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 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 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; we have incurred significant losses since our inception and it is our expectation that we will incur substantial losses in the future; 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; 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 www.sec.gov. Lipid Sciences assumes no obligation to update the forward-looking statements included in this document.
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Source: Lipid Sciences
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