TORONTO, March 10 /PRNewswire-FirstCall/ - Fralex Therapeutics Inc. (“Fralex” or the “Company”), a medical technology company developing a non-invasive neuromodulation device, today announced the randomization of the 100th patient into the RELIEF study. RELIEF is a multi-centre, double-blind placebo-controlled randomized clinical trial designed to assess the safety and efficacy of Complex Neural Pulse (CNP(TM)) therapy for the relief of chronic pain associated with fibromyalgia.
The data from the first 100 patients will serve as input to an interim analysis (“IA”) which will lead to a determination of the number of patients required - between 200 and 300 - to achieve statistical significance at the primary efficacy endpoint. Enrolment will not pause following the randomization of the 100th patient. The results of the IA are expected to be available in Q3 2008.
“The randomization of 100 patients into our pivotal RELIEF trial is a significant milestone for Fralex. Results of the interim analysis will allow us to predict the number of subjects required to achieve statistical significance,” said Avi Grewal, President and CEO of Fralex. “We believe that our CNP therapy has the potential to be a safe and effective, non-drug, non-invasive treatment for pain associated with fibromyalgia. The information from the interim analysis will be critical for developing timelines for the commercialization of our CNP therapy.”
The RELIEF trial is being conducted in the U.S. and Canada across 19 centres, under an Investigational Device Exemption (“IDE”) from the U.S. FDA and an Investigational Testing Authorization (“ITA”) from Health Canada. Patients are randomized on a one-to-one basis to receive CNP or placebo for 12 weeks. The primary efficacy endpoint will be a statistically significant difference between the active and placebo groups in the reduction of their Numerical Rating Score (“NRS”) pain scores between week 12 and baseline.
With success in achieving the primary safety and efficacy endpoints, the data from the RELIEF study will form part of a Premarket Approval (“PMA”) submission to the FDA. Fralex is seeking to be the first company to market a medical device in the U.S. and Canada which is indicated for the treatment of chronic pain associated with fibromyalgia.
About FRALEX:
FRALEX is a medical technology company focused on developing and commercializing Complex Neural Pulse or CNP(TM), a novel neuromodulation therapeutic technology for chronic pain, which utilizes specifically designed, low frequency electromagnetic pulses. FRALEX is proceeding with its FDA- and Health Canada-approved pivotal clinical trial (the “RELIEF” trial) to evaluate the safety and effectiveness of this technology in the treatment of chronic pain associated with fibromyalgia. The trial is to be conducted in 2007 and 2008 at leading medical centres within the U.S. and Canada. For more information on FRALEX, please visit www.fralex.com; further details on the RELIEF trial are posted on www.clinicaltrials.gov.
Certain statements contained in this release containing words like “believe”, “intend”, “may”, “expect”, and other similar expressions, are forward-looking statements that involve a number of risks and uncertainties. Factors that could cause actual results to differ materially from those projected in the Company’s forward-looking statements include the following: market acceptance of Company’s technologies and products; the ability to obtain financing; Company’s financial and technical resources relative to those of its competitors; Company’s ability to keep up with rapid technological change; government regulation of therapeutic technologies; the Company’s ability to enforce its intellectual property rights and protect its proprietary technologies; the ability to obtain and develop partnership opportunities; the timing of commercial product launches; the ability to achieve key technical milestones in its key product and other risk factors identified from time to time in the Company’s filings.
CONTACT: Avi Grewal, President and Chief Executive Officer, Fralex
Therapeutics Inc., (416) 213-8118 ext. 210, agrewal@fralex.com; Christina
Bessant, Investor Relations, The Equicom Group Inc., (416) 815-0700 ext.
269, cbessant@equicomgroup.com