FDA Grants Resverlogix Approval to Commence a Phase 1 Clinical Trial for RVX-208
Calgary, Canada (ots/PRNewswire)
- New Class of ApoA-I/HDL Drugs to Reverse Atherosclerosis Enters the Clinic
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
diseases.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 further.
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 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.
Website: http://www.resverlogix.com (RVX.)
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; Sarah Zapotichny,
Manager, Investor Relations, Resverlogix Corp., Phone:
+1-403-254-9252, Fax: +1-403-256-8495, Email: Sarah@resverlogix.com