Fralex Therapeutics Inc. initiates pivotal trial for chronic pain associated with fibromyalgia



    TORONTO, March 22 /CNW/ - 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.

    About Fibromyalgia
    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.

    About FRALEX:
    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.

    %SEDAR: 00024447E




For further information:

For further information: 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

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FRALEX THERAPEUTICS INC.

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