Fralex Therapeutics Inc. initiates pivotal trial for chronic pain associated with fibromyalgia
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- Published on Thursday, 22 March 2007 02:00
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TORONTO, Canada | Mar 22, 2007 | Fralex Therapeutics Inc. (TSX: FXI) ("Fralex" or the "Company"), a medical technology company developing neuromodulation therapy, today announced the initiation of RELIEF, its pivotal study for the treatment of chronic pain associated with fibromyalgia. The trial will evaluate the safety and effectiveness of the Company's non-drug, in-home therapy, Complex Neural Pulse(TM) (CNP(TM)). The first clinical trial site in Ottawa, Ontario, has been initiated and patient screening and recruitment will begin shortly.
"We are pleased that we have achieved our milestone of initiating the RELIEF trial within the first quarter of 2007 and look forward to initiating further clinical sites in Canada and the U.S. in the coming weeks," said Avi Grewal, President and CEO of Fralex. "We believe that CNP will significantly advance the practice of medicine in the treatment of various chronic, debilitating conditions by offering a non-invasive, relatively low-cost treatment option. Patients can regain control of their lives without having to deal with possible addiction issues, or other side effects that themselves seriously affect quality of life."
The RELIEF trial will enrol between 200 and 300 subjects across 13 centres in the U.S. and Canada, and is being conducted under an
Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) and an Investigational Testing Authorization (ITA) from Health Canada. Subjects will be randomized on a one-to-one basis to receive CNP or placebo for 12 weeks. The primary efficacy endpoint will be a statistically and clinically significant difference between the active and placebo groups in the proportion of the subjects who achieve a 30% or greater reduction in their NRS pain scores.
Fibromyalgia is a chronic, debilitating condition characterized by widespread musculoskeletal (MSK) pain, disturbed sleep, and fatigue along with multiple painful tender points, which are widely and symmetrically distributed. According to the American Pain Society, fibromyalgia is estimated to affect eight to twelve million people in the United States. Fibromyalgia is one of the most commonly diagnosed conditions in pain clinics in the United States. No treatments have been specifically approved for fibromyalgia in the United States or Canada.
FRALEX is a medical technology company focused on developing and commercializing Complex Neural Pulse(TM) 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-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 US and Canada. For more information on FRALEX, please visit www.fralex.com; further details on the RELIEF trial will be 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 key products and other risk factors identified from time to time in the Company's filings.
SOURCE: Fralex Therapeutics Inc