Procedures Well Tolerated By First Patient of Lipid Sciences' Human Clinical Trial
Posted on: Monday, 24 July 2006, 09:01 CDT
Lipid Sciences, Inc. (NASDAQ: LIPD) announced that the first patient in its human clinical trial had completed a series of seven procedures of plasma collection and re-infusion and the procedures were well tolerated. Additional patients have now been recruited into the trial and are undergoing the weekly procedures as planned.
The trial, "A Randomized Single-Blind Placebo Controlled Study to Evaluate the Safety of the Lipid Sciences' Plasma Delipidation System (PDS-2) in Subjects with Prior Acute Coronary Syndrome," is being conducted at the Washington Hospital Center in Washington, D.C. The trial consists of 7 weekly procedures of plasma collection and re-infusion per patient. The primary endpoint for this trial is to determine clinical safety and feasibility (patient recruitment, patient compliance, and analysis of data) in the targeted population. The secondary objective is to assess methods of analysis of data collected by intravascular ultrasound (IVUS). The study duration for each participant will be approximately 10 weeks. A total of 30 subjects will be recruited into the trial. Updates on patient enrollment and an indication of how the process is being tolerated by the patients will continue to be provided at regular intervals. Because it is a blinded trial, the Company 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.
Dr. Ron Waksman, Principal Investigator for the trial and Associate Director, Division of Cardiology, at Washington Hospital Center, commented, "It is important to note that the procedures have been well tolerated in not only the first patient, but by additional patients currently undergoing procedures as well, because the primary endpoint of this 'first in man' clinical trial is safety. It is my expectation that I will be able to present the complete safety and indication of effectiveness results from this trial at CRT (Cardiovascular Revascularization Therapies) 2007 to be held in Washington, D.C., March 7-9, 2007."
Dr. S. Lewis Meyer, President and Chief Executive Officer, noted, "As a result of the first few patients having tolerated the procedures so well, we have now begun a more aggressive patient recruitment effort and outreach program to local physicians. Statistics show that more than 1 in 5 acute coronary syndrome patients suffer a recurrence of an acute coronary event within 24 months even with the best current cardiovascular disease therapies. This compelling fact demonstrates that we are targeting an important potential market with our PDS-2 System. Our expectation is that there is an important role for HDL Therapy, especially in the Acute Coronary Syndrome patient, and that we have an answer to that unmet clinical need -- a plasma delipidation system that is economically competitive and a treatment that is feasible to deliver."
Additional information about the trial and the HDL Selective Delipidation business model can be found on the Company website at: www.lipidsciences.com at the Investor Relations tab with the heading "Annual Meeting of Stockholders, June 1, 2006." Copies are also available by contacting Lipid Sciences' Investor Relations at (925) 249-4031.
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; the significant losses we have incurred to date, and our expectation that we will incur substantial losses in the future; the failure of our 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; 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.
Press releases for Lipid Sciences, Inc. are available on our website: www.lipidsciences.com. If you would like to receive our press releases via email, please contact: info@lipidsciences.com.
FOR FURTHER INFORMATION CONTACT: Deborah S. Lorenz Vice President, Investor Relations and Corporate Communications Lipid Sciences, Inc. 925-249-4031 Contact via http://www.marketwire.com/mw/emailprcntct?id=9404D355F2394FF0 Wolfe Axelrod Weinberger Associates, LLC Donald C. Weinberger Contact via http://www.marketwire.com/mw/emailprcntct?id=AFB084D688EA1CBD Media: Alisa Steinberg Contact via http://www.marketwire.com/mw/emailprcntct?id=E83E148694D00EED 212-370-4500
SOURCE: Lipid Sciences, Inc.
Source: MARKET WIRE
Related Articles
- Pennsylvania Patient Safety Authority Supports 'National Patient Safety Day'
- Phase II Trial Demonstrates Elacytarabine May Increase Survival Threefold in Patients With Late-Stage Leukaemia
- Kouros Azar, M.D. (doctorazar.com), Noted Plastic and Reconstructive Surgeon, Offers Top 10 Tips to Patients to Help Celebrate National Patient Safety Awareness Week
- European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI
- A Look at Medicare Patients with Heart Pumps
- New Data is Presented on Investigational Oral Anticoagulant Apixaban in Acute Coronary Syndrome Patients
- GE Healthcare Receives FDA Clearance for CARESCAPE Patient Data Module for Mobile Patient Monitoring
- Real-World Taxus(R) Stent Data Confirm Favorable Outcomes for Patients With Complex Coronary Artery Disease
- Biopure Completes Patient Enrollment in European Phase 2 Clinical Trial of Hemopure(R) in Coronary Angioplasty Patients
- GenVec Launches Phase IIB Trial in Patients With Severe Coronary Artery Disease
User Comments (0)

RSS Feeds