TORONTO, Sept. 25 /PRNewswire-FirstCall/ - Fralex Therapeutics Inc. (TSX:FXI) ("Fralex" or the "Company"), a medical technology company developing a non-invasive neuromodulation device, today provided an update on receiving results of the interim analysis for the RELIEF pivotal study. The trial is investigating the use of Complex Neural Pulse or CNP(TM) therapy for the relief of chronic pain associated with fibromyalgia.
The Independent Data Monitoring Committee ("DMC") is scheduled to meet on October 2, 2008, to review data from the first 100 patients enrolled in the trial. Immediately thereafter, the Company anticipates receiving the DMC's recommendations as to whether to continue the trial, or conversely, discontinue for reasons of safety or futility. If the trial continues, the DMC also is expected to recommend the number of patients, between 200 and 300, required to adequately power the study.
The Company will consider the DMC's report and provide an update as soon as practically possible.
About the RELIEF Trial:
The RELIEF trial is investigating the safety and efficacy of CNP(TM) for pain associated with fibromyalgia and is being conducted in the U.S. and Canada across its 16 active 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(TM) or placebo for 12 weeks. The primary efficacy endpoint is a statistically significant difference between the active and placebo groups in the proportion of the patients who achieve a 30% or greater reduction of their Numerical Rating Scale pain score between their pre-treatment baseline and week 12 of therapy.
FRALEX is a medical technology company focused on developing and commercializing CNP(TM), a novel neuromodulation therapeutic technology for chronic pain, which utilizes specifically designed, low-frequency electromagnetic pulses. FRALEX is proceeding with the "RELIEF" trial to evaluate the safety and effectiveness of this technology in the treatment of chronic pain associated with fibromyalgia. For more information on FRALEX, please visit http://www.fralex.com; further details on the RELIEF trial are posted on http://www.clinicaltrials.gov.
Certain statements contained in this release containing words like "believe", "intend", "may", "expect", "anticipate" 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 the Company's technologies and products; the Company's ability to obtain financing and on acceptable terms; the Company's financial and technical resources relative to those of its competitors; the 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 Company's ability to obtain and develop partnership opportunities; the timing of commercial product launches; the Company's ability to achieve key technical milestones in its key product, and other risk factors identified from time to time in the Company's public filings.
|SOURCE Fralex Therapeutics Inc.|
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