TSX Exchange Symbol: RVX
Additional quarterly and clinical updates included
CALGARY, Aug. 25 /CNW/ - 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. These articles can be found at
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
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.
For further information:
For further information: Theresa Kennedy, VP, Corporate Communications,
Resverlogix 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: