Resverlogix Presents ASSERT Human Clinical Trial Data at the American Heart Association Late Breaker Session
By Resverlogix Corp., PRNETuesday, November 16, 2010
A Second AHA Presentation Includes Mouse Model Data Showing Plaque Reduction.
CHICAGO, November 17, 2010 - Resverlogix Corp. ("Resverlogix") (TSX:RVX) announces its top line
results of the ASSERT Phase 2 clinical trial which will be highlighted at the
prestigious American Heart Association Scientific Sessions 2010 Late Breaking
Clinical Trial session, by principal investigator Dr. Stephen Nicholls of the
Cleveland Clinic. The top line ASSERT trial data was designed to answer
questions about how to best proceed with future trial designs for
Resverlogix' lead oral small molecule drug RVX-208.
The ASSERT trial data demonstrated that the three key biomarkers in the
reverse cholesterol transport (RCT) process showed dose dependant and
consistent improvement. The trial showed dose dependent increases in ApoA-l,
statistically significant increases in HDL cholesterol including alpha1
particles or functional HDL, and highly statistically significant increases
in large HDL particles. RCT is a pathway by which accumulated cholesterol is
transported from the arterial wall to the liver for excretion, thus reducing
and/or preventing atherosclerosis.
In the high dose, ApoA-I achieved a 5.6% increase with a statistical
value of p=0.06. The overall ApoA-I biomarker showed a dose trending
statistical significance of p=0.035. Data presented also showed that the
ApoA-I and other HDL particles continued to be increasing at the end of the
12 week study. Both the 8.3% HDL cholesterol increase and the 21.1% large
particle HDL increase were highly statistically significant, p<0.01 and
p<0.001 respectively. These pronounced HDL related increases via ApoA-I
production are important as they take place later in the RCT chain of events
and strongly indicate plaque regression potential.
"These are very encouraging early findings which suggest the drug
(RVX-208) is working in the established patient population that it was
designed for, being patients with advanced coronary disease," said Dr.
Stephen Nicholls, MBBS, PhD, Medical Director of Intravascular Ultrasound and
Angiography Core Laboratories at Cleveland Clinic and Clinical Director of
the Cleveland Clinic Center for Cardiovascular Diagnostics and Prevention.
Donald McCaffrey, President and Chief Executive Officer of Resverlogix
commented, "The study largely replicates findings previously seen in our
earlier 28 day trial, more importantly these findings are now being shown in
patients with coronary artery disease on optimal standard of care. The
positive changes seen in this trial represent advancement over the current
best standard of care available in the USA. We are now well positioned to
advance RVX-208 to the next clinical trial having witnessed the substantial
and consistent elevation of HDL by ApoA-I production; which strongly
indicates that RVX-208 should remove unwanted plaque from the arterial wall
which is our main goal."
Resverlogix Senior Vice President of Medical Affairs Dr. Jan Johansson
stated, "In patients who received the newer class of statins and had baseline
HDL below 45mg/dL, an important high-risk subpopulation, the middle dose of
200 mg saw the most pronounced increases of 12% in ApoA-I (p<0.002), 21% in
HDL cholesterol (p<0.015) and 32% in large particle HDL (p<0.018). We are
delighted by these results and now have a much better understanding of what
doses to use and what patient population to target moving forward in our
ASSURE Phase 2b trial."
An additional presentation at the AHA meeting was given by Dr. Norman
Wong, Chief Scientific Officer of Resverlogix, containing new data detailing
the effects of RVX-208 in vivo. The presentation was titled "RVX-208: An
Orally Administrated Small Molecule Reduces Atherosclerosis in ApoE Null
Mouse and Raises ApoA-I/HDL in Humans". In the ApoE null mice model of
atherosclerosis, the oral administration of RVX-208 reduced aortic plaques in
two separate models. The presented model showed plaque reductions of up to
41%.
Resverlogix to Host Webcast on ASSERT Phase 2 Trial Results - change in
time Resverlogix Corp. will host a live teleconference and webcast today at
2:15 pm Central/1:15 pm Mountain time. The purpose of the teleconference is
to discuss the top line results of the Company's Phase 2 clinical trial
(ASSERT) for RVX-208. 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
services.choruscall.com/links/resverlogix101117.html.
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) PR program is the Company's
primary focus which is to develop novel small molecules that enhance ApoA-l.
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 to research, development and commercialization of
novel therapeutics that reduce the risk of cardiovascular disease including
atherosclerosis, diabetes, Alzheimer's disease, Peripheral Artery Disease 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 July 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
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responsibility for the adequacy or accuracy of this news release.
For further information: Donald J. McCaffrey President & CEO Resverlogix Corp. Phone: +1-403-690-8887 Email: Don@resverlogix.com Media: Eric Goldman Rx Communications Group Phone: +917-322-2563 egoldman@rxir.com US Institutional Investors Susan Noonan Managing Partner S.A. Noonan Communications, LLC Phone: +1-212-966-3650 Email: Susan@sanoonan.com
For further information: Donald J. McCaffrey, President & CEO, Resverlogix Corp., Phone: +1-403-690-8887, Email: Don at resverlogix.com; Media: Eric Goldman, Rx Communications Group, Phone: +917-322-2563, egoldman at rxir.com; US Institutional Investors: Susan Noonan, Managing Partner, S.A. Noonan Communications, LLC, Phone: +1-212-966-3650, Email: Susan at sanoonan.com
Tags: Chicago, Illinois, November 17, Resverlogix Corp.