Viron Therapeutics Initiates Phase 2 Clinical Trial
September 26, 2005

 

Viron Therapeutics Inc., a drug development company, announced today the initiation of its first Phase 2 clinical trial with its lead anti-inflammatory drug, VT-111, for the treatment of Acute Coronary Syndromes (ACS). The trial, which is approved by the U.S. FDA and Health Canada, is designed to test what could become the first in a completely new class of therapeutic compounds for the treatment of inflammatory-based disorders.

"This is the first protein of its kind to enter clinical trials and we are extremely pleased to have reached this milestone," said Neil K. Warma, Viron's President & CEO. "VT-111 has shown a remarkable ability to reduce atherosclerosis and increase the stability of vulnerable plaques that can cause heart attacks. We are very excited about the possibility of translating this groundbreaking research into a life saving medicine. This study could also significantly contribute to the validation of our novel scientific platform."

The trial protocol was designed with the input of leading cardiologists and cardiovascular researchers and is being managed by world-renowned investigators. The trial is a placebo-controlled, double-blind, dose escalating study that will enroll 72 patients who present with ACS requiring intervention. The primary objective will be to assess safety through the measurement of major adverse cardiac events, the monitoring of clinical adverse events and the detection of any signs and symptoms of drug toxicity. The study will attempt to detect a trend in efficacy through the measurement of circulating biochemical inflammatory markers, as well as assessing restenosis rates six months post-treatment using intravascular ultrasound (IVUS).

Dr. Jean-Claude Tardif, Director of the Research Centre of the Montreal Heart Institute and Principal Investigator overseeing the IVUS core laboratory for the trial, added the following comments. "We have been very encouraged by the preclinical data supporting the compound, which indicates that VT-111 directly targets the underlying inflammation associated with atherosclerosis. We believe that VT-111 is ideally suited to treating the serious complications caused by inflammation in ACS and if VT-111's promise translates into the clinic, the drug could offer cardiologists a new and powerful tool with which to combat the disease."

About VT-111
VT-111 is the lead compound of a novel class of virally derived biologics being developed by Viron that exhibit potent anti-inflammatory abilities. It has shown remarkable efficacy in a variety of preclinical animal models of inflammatory-based conditions including ACS, transplantation and rheumatoid arthritis. VT-111 was shown to be safe and well tolerated in healthy volunteers in a Phase 1 study. The potential of VT-111 to quickly stabilize patients with ACS could result in a reduction of patients who require surgical intervention, thereby reducing the incidence of heart attacks and death.

About Viron Therapeutics Inc.
Viron Therapeutics Inc. is a biopharmaceutical company based in London, Ontario, Canada with a leading position in the development of drugs to treat inflammatory disorders. Viron is a pioneer in exploiting natural viral proteins as innovative drugs for the treatment of human disorders resulting from abnormal inflammatory responses, such as cardiovascular disease, transplant vasculopathy and rheumatoid arthritis. The advancement of VT-111 into Phase 2 clinical trials, a pipeline of five promising preclinical candidates and a robust discovery program strongly position the Company to be a leader in the treatment of inflammatory disorders.