Fralex provides update on timing of interim analysis results



    TORONTO, Sept. 25 /CNW/ - 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.

    About FRALEX:

    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 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", "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.

    %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; or Casey Gurfinkel, Investor Relations, The Equicom Group
Inc., (416) 815-0700 ext. 283, cgurfinkel@equicomgroup.com

Organization Profile

FRALEX THERAPEUTICS INC.

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