- Interim analysis results expected in Q3 2008 -
TORONTO, March 10 /CNW/ - Fralex Therapeutics Inc. (TSX:FXI) ("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.
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.
For further information:
For further information: Avi Grewal, President and Chief Executive
Officer, Fralex Therapeutics Inc., (416) 213-8118 ext. 210,
firstname.lastname@example.org; Christina Bessant, Investor Relations, The Equicom Group
Inc., (416) 815-0700 ext. 269, email@example.com