Resverlogix Phase 1b/2a Study Meets Primary Endpoint
Additional quarterly and clinical updates included
CALGARY, Aug. 25 /PRNewswire-FirstCall/ -- Resverlogix Corp. (TSX:RVX) is pleased to announce several quarterly updates. The Phase 1b/2a study testing RVX-208 for 28 days in three different doses has met its primary endpoint of increasing plasma ApoA-I significantly. Quality controls are still ongoing as part of regular good clinical practice, thus the compilation of the full data report should take place within the second half of 2009. As such if there are modifications to this endpoint they will be communicated. This successful data, in combination with the drug showing favorable safety and tolerance characteristics, is expected to see RVX-208 progress into Phase 2 studies in cardiovascular disease patients.
ApoA-I is the core protein of HDL, often termed the good cholesterol, and ApoA-I is generally endorsed as a key protective factor against atherosclerosis and cardiovascular disease. Developing small molecules increasing ApoA-I would satisfy a huge unmet medical need. This selective early analysis will be communicated in private meetings at the European Society of Cardiology starting at the end of this month. The plasma ApoA-I increase is significant during treatment and at the lowest dose, while continued increases follow a dose-response and time-response pattern. This data is building on similar results from non-human primate studies and a previous 7-day study in humans last year that also showed significant ApoA-I increases. The safety data has not yet been compiled according to who received active or placebo treatment, nevertheless, based on the number and degree of adverse events in total, safety blood analysis and conduct of the study it can be concluded that RVX-208 is safe and tolerable at doses efficient in increasing plasma ApoA-I concentrations.
A protocol is being been compiled together with the IVUS Steering Committee including Drs. Nissen, Nicholls, Ballantyne, Taylor, and Kastelein for a Phase 2 study in cardiovascular disease patients which will be discussed in conjunction with the 2009 European Society of Cardiology Congress meeting in Barcelona, Spain. Resverlogix will be attending this important cardiovascular meeting and will communicate the results of the 28 day study to potential partners in greater detail, under confidentiality agreement. Furthermore, Dr. Norman Wong will present RVX-208 data on September 2, 2009 for Resverlogix during this meeting.
Since RVX-208 increases ApoA-I by production the Phase 1b/2a trial also examined early markers for ApoA-I production and reverse cholesterol transport such as pre-beta-HDL and Alpha1-HDL. Approximately half of the subjects had low levels of HDL cholesterol, a condition associated with significant increased risk of cardiovascular disease.
"Showing in the Phase 1b/2a trial that we met the primary endpoint of increasing plasma ApoA-I in a safe and tolerable way is a huge milestone for Resverlogix," stated Donald J. McCaffrey, President CEO of Resverlogix. "There is an enormous unmet medical need in treating atherosclerosis and cardiovascular disease and the ApoA-I increases achieved by RVX-208 may just do that. We expect to update shareholders with further details of these activities later this year," added McCaffrey.
In addition to successfully completing the Phase 1b/2a trial, Resverlogix has also completed two arms of a Phase 1 BE (bio-equivalency) study for RVX-208 with the final arm being scheduled for completion in the end of the third quarter. The Phase 1 BE trial is a program designed to show that the newly formed capsule version of RVX-208 is equivalent to the earlier powder in a bottle version that has been used in all trials to date.
In unrelated news Mr. Kelly McNeill, Resverlogix CFO, will be leaving his current position effective September 18, 2009 and returning to Winnipeg for family reasons. Due to Mr. McNeill's important contributions to the ongoing corporate development of Resverlogix the Board of Directors in conjunction with Mr. McNeill have agreed to nominate Mr. McNeill as a corporate director at the upcoming October 15th, 2009 Annual General Meeting. Mr. McNeill's promotion to the Board of Directors is a welcome addition that will allow the corporation to continue to benefit from Mr. McNeill's in depth knowledge of Resverlogix and its upcoming corporate development plans.
Resverlogix has recently published one paper in a chemistry publication, Tetrahedron 2009, 65, 6932. Resverlogix will continue to publish a series of research papers demonstrating Resverlogix's understanding of the ability to induce the expression of the Apo A1 gene by small molecules.
Two new important papers have been added to the Resverlogix corporate web site. The first is a detailed White Paper describing Resverlogix understanding of the Reverse Cholesterol Transport system and the Company's targeted goals of reducing the Percent Atheroma Volume (PAV) plaque build up in the arterial wall. The second paper is an abstract of a recently completed Pharmacoeconomics study showing the potential economic impact of being able to reduce the PAV as it relates to the impact on the overburdened US health system.
RVX-208, a novel small molecule therapeutic that facilitates endogenous ApoA-I production, is positioned to be one of the most promising emerging drugs in the treatment of atherosclerosis. To the Company's knowledge RVX-208 is the only novel small molecule that is specifically designed to increase ApoA-I production and thereby raise HDL levels thus enhancing HDL functionality to augment reverse cholesterol transport (RCT).
RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus preventing atherosclerosis. Major constituents of RCT include acceptors such as high-density lipoprotein (HDL) and apolipoprotein A-I (ApoA-I). A critical part of reverse cholesterol transport is cholesterol efflux, in which accumulated cholesterol is removed from macrophages.
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 needs. The NexVas(TM) PR program is the Company's primary focus which is to develop novel small molecules that enhance ApoA-I. These vital therapies address the grievous 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. trades on the Toronto Stock Exchange (TSX:RVX). For further information please visit www.resverlogix.com.
This news release may contain certain forward-looking statements that reflect the current views and/or expectations of Resverlogix Corp. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly. The TSX Exchange does not accept responsibility for the adequacy or accuracy of this news release.
Source: Resverlogix Corp.
CONTACT: Theresa Kennedy, VP, Corporate Communications,
Corp., Phone: (604) 538-7072, Fax: (403) 256-8495, Email:
Theresa@resverlogix.com; Sarah Zapotichny, Manager Investor Relations,
Resverlogix Corp., Phone: (403) 254-9252, Fax: (403) 256-8495, Email:
Posted: August 2009