CALGARY, May 12 /PRNewswire-FirstCall/ - Resverlogix is pleased to announce that the Phase 2 ASSERT clinical trial for its lead drug, RVX-208, a small molecule therapy for the treatment of atherosclerosis has now completed dosing. “The completion of dosing for our Phase 2 ASSERT trial, five months ahead of schedule and without any alterations to the dose levels of the three drug receiving cohorts, is another major step forward in the development of this important cardiovascular drug. Our clinical team and our collaborators at the Cleveland Clinic will now spend the next few months assessing the study results to best plan for upcoming trials. The swift completion of the ASSERT study further allows us to make better assessments in identifying optimal dosing regimens moving forward,” explained Donald J. McCaffrey, President and CEO of Resverlogix. McCaffrey continued, “Earlier studies have indicated that the drug worked best in those subjects with low HDL, therefore we will further assess if RVX-208 has a targeted effect in this high risk cardiovascular disease population. The rapid enrollment and dosing success for this trial was in large part due to having one organized Internal Review Board (IRB) for all 40 sites involved in the trial.”
The ASSERT trial is a randomized, double-blind, placebo-controlled, multi-centered US study for 13 weeks of administration of RVX-208, which has enrolled 299 patients with stable coronary artery disease for a period of 13 weeks. The primary endpoint of the study is to determine if RVX-208 will produce an increase in plasma Apolipoprotein A-I (ApoA-I) levels compared to placebo group after three months of dosing. Other objectives are to examine the safety and tolerability of RVX-208 and to compare the dose and time response relationship for ApoA-I as well as to examine key reverse cholesterol markers involved with HDL functionality.
In related clinical news the parallel Phase 2 ASSURE trial for RVX-208, which announced its first site activation on February 25th, will be reassessing its enrollment procedure. Since the ASSERT trial provides us with data much faster than first anticipated, we can also now apply pertinent findings to the ASSURE trial. In order to expedite enrollment, while continuing our primary patient safety concerns, the ASSURE trial is being voluntarily halted on a temporary basis in order to modify enrollment procedures. “While the ASSERT trial set records for enrollment, the much more intricate ASSURE trial will not for the reason that the inclusion criteria is much more detailed and intensive. ASSURE currently requires a patient must have had a heart attack within the past four weeks. The patient is then required to voluntarily submit to having two invasive Intravascular Ultrasound (IVUS) both at the start and finish of the 90 day drug treatment period. We believe that we can enhance the enrollment procedure by modifying the inclusion criteria. One such option would be to include any patients sent to the Catheter Lab, thus greatly increasing the pool of patients that we would be able to draw from for enrolment in this trial. Patients will also now benefit from any added knowledge that we are about to gain from the successful completion of dosing in the ASSERT trial,” stated Donald McCaffrey.
In other news today, Donald J. McCaffrey will be providing an updated corporate and clinical overview at 1:00 pm EDT. A slide presentation will be followed by a question and answer session regarding the impact of the early completion of the ASSERT trial and the enhancement of enrollment procedures for the ASSURE trial.
The dial-in numbers for this event are toll free 1-800-319-4610 and international 1-604-638-5340. A link for this webcast will be posted onto the homepage of Resverlogix’s website and can be accessed from the following address http://services.choruscall.com/links/resverlogix100511.html.
The webcast will be available on the Resverlogix website for replay for a period of 45 days after the event.
About Resverlogix Corp.
Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet medical needs. The NexVas(TM) Plaque Regression program is the Company’s primary focus which is to develop novel small molecules that enhance ApoA-I. These vital therapies address the burden of atherosclerosis and other important diseases such as Acute Coronary Syndrome, Diabetes, Alzheimer’s disease, Peripheral Artery Disease and other vascular disorders. Resverlogix Corp.'s common shares trade on the Toronto Stock Exchange (TSX:RVX). For further information please visit www.resverlogix.com.
This news release may contain certain forward-looking statements as defined under applicable Canadian securities legislation, including our statements with respect research, development and commercialization of novel therapeutics that reduce the risk of cardiovascular disease including atherosclerosis, stable Coronary Artery Disease, Acute Coronary Syndrome and other vascular diseases. These forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous known and unknown risks and uncertainties including but not limited to those associated with the success of research and development programs, clinical trial programs including possible delays in patient recruitment, the regulatory approval process, competition, securing and maintaining corporate alliances, market acceptance of the Company’s products, the availability of government and insurance reimbursements for the Company’s products, the strength of intellectual property, financing capability, the potential dilutive effects of any financing, reliance on subcontractors and key personnel and additional risk factors discussed in other documents we file from time to time with securities authorities, which are available through SEDAR at www.sedar.com. Additionally, risks and uncertainties are discussed in detail in the January 31, 2010 MD&A. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The TSX Exchange does not accept responsibility for the adequacy or accuracy of this news release
SOURCE Resverlogix Corp.
