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Resverlogix RVX-208 Second Clinical Trial Demonstrates Success on Key Reverse Cholesterol Transport Markers

Geschrieben am 29-09-2009

Calgary, Canada (ots/PRNewswire) -

- Powerful Effects Seen in all Subjects Including Those With Low
HDL - Representing a Majority of Myocardial Infarct Patients

TSX Exchange Symbol: RVX

Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX)
announced today that results from the Company's Phase 1b/2a clinical
trial have met and exceeded expectations by successfully concluding
the drug, RVX-208, is safe and tolerable. Most importantly RVX-208
has met its primary endpoint to increase the production of plasma
ApoA-I, the key cardioprotective protein in high-density lipoprotein
(HDL), often referred to as "good" cholesterol. ApoA-I is generally
endorsed as a key protective factor against atherosclerosis and
cardiovascular disease with 40% of all first heart attack patients
having low ApoA-I.

Resverlogix's Phase 1b/2a study tested RVX-208 for 28 days in
three different dosing arms. The most pronounced results were
demonstrated among those subjects with low HDL cholesterol levels.
Low HDL is an important risk factor in coronary and cardiovascular
disease patients. Resverlogix will continue to build upon its world
leading position in development of novel small molecules that
increase ApoA-l production and reverse cholesterol transport (RCT)
markers in patients with high vascular risk profiles. RCT is a path
by which cholesterol on the arterial wall is transported back to the
liver by ApoA-I lipid complexes for excretion. Additional analysis
was performed on other key RCT markers which achieved high levels of
statistical significance. The Company has established a dosing range
that it deems will be safe, well tolerated and effective for Phase 2
intravascular ultrasound (IVUS) development trials.

"The range of increase in ApoA-l production of all subjects, but
in particular low HDL subjects over placebo demonstrated in this
study is one of the most significant pieces of data for RVX-208. We
have exceeded our original expectation for enhancing ApoA-l
production in humans," stated Donald J. McCaffrey, President and CEO
of Resverlogix. "We know that the enhancement of ApoA-l and key RCT
particles in the body is widely recognized by international experts
as the necessary markers to potentially impact atherosclerosis
regression. Hence, we have achieved another critically important
clinical milestone for our Company," noted McCaffrey.

The Phase 1b/2a trial was a double blind safety and tolerance
study which investigated the pharmacokinetics and also early
pharmacodynamics effects of RVX-208. A total of 72 subjects enrolled
in the trial. The study had three arms, a low dose arm with 24
subjects, a dose-escalation arm with 24 subjects, and a third high
dose arm with 24 subjects. This trial also examined early markers for
reverse cholesterol transport such as ApoA-l, HDL-c, pre-beta HDL and
alpha HDL subparticles. Approximately half of the subjects had low
levels of baseline HDL cholesterol.


Highlights from the study are as follows:
- The primary endpoint, plasma ApoA-I increase compared to placebo,
achieved a range in all subjects of 5.1% - 10.4% in all doses at days
8 and 28 respectively.
- At the lowest dose of 1mg/kg b.i.d. in subjects with low levels of
HDL-c, plasma ApoA-l increases reached statistical significance of
5.7% (p(less than)0.05) at day 8 and 7.8% (p(less than)0.05) at
day 28.
- A critical RCT functionality marker, alpha-1 HDL particles,
illustrated highly statistical significance with an increase of
46.7% (p(less than)0.004), in all subjects and
57.2% (p(less than)0.02) in the low dose arm over placebo at day 28.
- Pharmacokinetic parameters of RVX-208 were dose dependant with oral
administration.
- RVX-208 was shown to be compatible with simvastatin (40mg).
- Seventy out of seventy two subjects completed the trial. One subject
did not complete the trial due to personal reasons and one other
subject did not complete the trial due to a serious adverse event,
cholecystitis (gall stones), which was judged not related to the
study drug.


Based on these important findings, the Company now plans to
adjust its future dosing. Expanded Phase 2 planning is moving forward
to include Phase 2 IVUS trials, a Phase 2 dosing trial and a Phase 2
combination statin trial. The IVUS Steering Committee is chaired by
Dr. Steven Nissen, Chairman of the Cleveland Clinic Department of
Cardiovascular Medicine, and the principal investigator is Dr.
Stephen Nicholls, Medical Director of Intravascular Ultrasound at
Cleveland Clinic.

"The results we have observed in our second clinical trial
illustrate an important emerging pattern of predictability. To date
162 human subjects have received RVX-208 which has consistently
demonstrated itself to be a well tolerated and safe therapeutic,"
stated Dr. Jan Johansson Senior Vice President of Medical Affairs at
Resverlogix. "It is important to note that in addition to the
increases in ApoA-I and HDL, we also saw very pronounced increases in
alpha-1 HDL, another important marker for CVD risk. The landmark
Framingham Offspring Study clearly illustrated that among HDL and
LDL, alpha-1 HDL was a more critically important marker for CVD
protection," Dr. Johansson added.

Developing small molecules that increase ApoA-I would satisfy a
huge unmet medical need because CVD treatment with statins, the
current standard of care, only stabilizes atherosclerosis and reduces
cardiovascular risk by 30%. A recent cost-benefit pharmacoeconomic
analysis of ApoA-I therapy for CVD estimated that a 1% and 5%
regression of atherosclerosis would save the U.S. health care system
and employers between USD $22.9 billion and USD $76.8 billion
annually over and above statin therapy. The analysis assumes ApoA-I
therapy will be given to CVD patients in combination with statins.
ApoA-I therapy has the potential to reduce the overall cost of
cardiovascular disease, which is estimated in the U.S. at USD $475
billion annually, by 5% to 16%.

Resverlogix is also pleased to announce that it will host a live
teleconference today, September 29, 2009 at 1:00 pm Eastern/11:00 am
Mountain time. The purpose of the teleconference is to discuss the
top line results of this clinical 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 is posted onto the homepage of Resverlogix's
website and can be accessed from the following address
http://services.choruscall.com/links/resverlogix090928.html. The
webcast will be available on the Resverlogix website for replay for a
period of 45 days after the event.

About RVX-208

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.

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 http://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: Theresa Kennedy, VP, Corporate
Communications, Resverlogix Corp., Phone: +1(604)-538-7072, Fax:
+1(403)-256-8495, Email: Theresa@resverlogix.com; US Investor
Relations, Susan Noonan, Managing Partner, S.A. Noonan
Communications, LLC, Phone: +1(212)-966-3650, Email:
susan@sanoonan.com; US Media Relations, Eric Goldman, Vice President,
Rx Communications Group, Phone: +1(917)-322-2563, Email:
egoldman@rxir.com

ots Originaltext: Resverlogix Corp.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information: Theresa Kennedy, VP, Corporate
Communications,
Resverlogix Corp., Phone: +1(604)-538-7072, Fax: +1(403)-256-8495,
Email:
Theresa@resverlogix.com; US Investor Relations, Susan Noonan,
Managing
Partner, S.A. Noonan Communications, LLC, Phone: +1(212)-966-3650,
Email:
susan@sanoonan.com; US Media Relations, Eric Goldman, Vice President,
Rx
Communications Group, Phone: +1(917)-322-2563, Email:
egoldman@rxir.com


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