Calgary, Canada (ots/PRNewswire) -
- New Class of ApoA-I/HDL Drugs to Reverse Atherosclerosis Enters
Resverlogix Corp. ("Resverlogix") (TSX:RVX) announced today that
it has received approval by the US Food and Drug Administration (FDA)
to initiate a Phase 1a clinical trial of oral RVX-208 in the USA.
RVX-208 is a novel first-in-class small molecule that increases the
production of ApoA-I and HDL. ApoA-I is regarded as the critical
cardioprotective protein for the treatment of cardiovascular
The Phase I clinical trial is taking place at a leading US
contract research organization. The trial consist of three arms, an
ascending single dose, a fed and fasted dose effect study, and a
7-day ascending multiple dose that will enroll a total of 70-80
healthy volunteers. The primary objective of the trial is to evaluate
oral RVX-208 in healthy adult subjects for safety, tolerability, and
pharmacokinetics. Results from this Phase 1a trial will be used for
optimizing dosing for future trials including our Phase 1b trial.
Gregory S. Wagner, PhD, Senior Vice President, Preclinical
Development of Resverlogix, stated that, "RVX-208 possesses a very
favorable pharmacological and pharmaceutical profile. This compound
is an excellent choice to be the first drug candidate from our
preclinical pipeline, our research and development team has worked
aggressively to rapidly advance it into clinical development."
"This field has been developing for 50 years. In multiple human
and animal studies over-expression or repeated infusion of ApoA-I
inhibit progression and induce regression of atherosclerosis in both
animals and humans," stated Dr. Jan Johansson, MD, PhD. Senior Vice
President of Clinical Affairs of Resverlogix. "We have identified a
way to increase the endogenous production of ApoA-I via a small
molecule drug. The initiation of this clinical trial is a milestone
for the field of ApoA-I research," confirmed Dr. Johansson.
"Clearance of our investigational new drug application from the US
Food and Drug Administration was a major accomplishment for our
company; however, beginning the clinical assessment is, to date,
Resverlogix's most important milestone," said Mr. Donald McCaffrey,
President and CEO of Resverlogix. "We are thrilled to expedite the
RVX-208 clinical program during 2008 illustrating its clinical
benefit to treat atherosclerosis disease. To be able to increase
ApoA-I and functional HDL with a novel small molecule in humans
represents not only the next major milestone for our Company, but
also for cardiovascular patients worldwide," Mr. McCaffrey added
About Cardiovascular Disease (CVD)
CVD can be generally defined as any abnormal condition
characterized by dysfunction of the heart and blood vessels. CVD
includes atherosclerosis (especially coronary heart disease which can
lead to heart attacks), cerebrovascular disease (stroke), and
hypertension (high blood pressure). The underlying cause of most CVD
is a gradual clogging of the arteries (atherosclerosis) that supply
blood to the heart, brain and other vital organs.
The American Heart Association estimates that almost 80 million
American Adults have one or more types of cardiovascular disease. CVD
remains the number one killer of developed nations. Nearly 2400
Americans die each day from cardiovascular disease - that is 1 person
will die every 36 seconds.
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) 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 and other vascular
disorders. The Company's secondary focus is TGF-Beta Shield(TM), a
program that aims to address burgeoning grievous diseases, such as
cancer and fibrosis. Resverlogix Corp. trades on the Toronto Stock
Exchange (TSX:RVX). For further information please visit
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.
Website: http://www.resverlogix.com (RVX.)
ots Originaltext: Resverlogix Corp.
Im Internet recherchierbar: http://www.presseportal.ch
For further information: Theresa Kennedy, VP, Corporate
Communications, Resverlogix Corp., Phone: +1-604-538-7072, Fax:
+1-403-256-8495, Email: Theresa@resverlogix.com; Sarah Zapotichny,
Manager, Investor Relations, Resverlogix Corp., Phone:
+1-403-254-9252, Fax: +1-403-256-8495, Email: Sarah@resverlogix.com