Navigation Links
Fralex provides update on timing of interim analysis results
Date:9/25/2008

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.

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 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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Vanda Pharmaceuticals Provides Update on Iloperidone
2. Study Demonstrates That AHCC(R) Provides Immune Enhancement Against the West Nile Virus
3. Study Reveals Novel LCD Solution Provides Significant Benefits Versus Calcipotriol In Treatment Of Moderate Psoriasis
4. New Research Provides Evidence that Tea May Improve Attention and Focus, Keep Brain Cells Healthy, & Influence Genetics in Cancer
5. Eisai Provides Preliminary Efficacy Update On EORTC Phase III Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes
6. IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following June Meeting of European Committee for Medicinal Products for Human Use (CHMP)
7. New Data Demonstrates 5-FU Personalized Chemotherapy Management (PCM(R)) Assay Provides Similar Performance to More Complicated Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
8. Results From One-Year Study Suggest Advair(R) Provides Important Benefits for African American Patients With Asthma
9. Sangamo BioSciences Provides Update on Diabetic Neuropathy Clinical Programs
10. Clinical Proof of Concept for TGF-beta 2-Inhibitor AP 12009 in Phase Iib EMEA provides Guidance on Phase III Design and Approval Requirements
11. CNS Response, Inc. Provides Review of Poster Session Delivered at the American Psychiatric Association 161st Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... CITY, Mo. , May 3, 2016 /PRNewswire/ ... Kansas Medical Center,s Institute for Advancing Medical Innovation ... and commercialize new drugs, diagnostics and medical devices. ... provides BioNovus Innovations with rights to license, develop ... "This partnership represents ...
(Date:5/3/2016)... 2016  Axiogenesis has acquired a major investment from Sino-German High-Tech Fund to further expand product development, strengthen its ... http://photos.prnewswire.com/prnh/20160503/362921 ... ... ... ...
(Date:5/3/2016)... 2016 ACME Markets, ... Delaware County Councilman Dave White ... all ACME pharmacies across Delaware ... and Prevention (CDC), naloxone has saved 26,463 lives nationwide over the ... Delaware County were authorized to administer naloxone to ...
Breaking Medicine Technology:
(Date:5/5/2016)... ... May 05, 2016 , ... In the midst of making plans ... most important arrangement — planning a safe way of getting home after the festivities. ... Unfortunately, these celebrations often lead to drunk drivers on the roads who become involved ...
(Date:5/5/2016)... , ... May 05, 2016 , ... Is the part ... Mother’s Day just a few days away, it’s a good opportunity to raise awareness ... to the American Academy of Dermatology, 40% of women experience hair loss or ‘thinning’ ...
(Date:5/5/2016)... ... May 05, 2016 , ... ... for blood and service orders. Blood suppliers and their hospitals use BloodHub ... “BloodHub serves 13,000 active users across 2,100 hospitals who use our platform to ...
(Date:5/5/2016)... Wisconsin (PRWEB) , ... May 05, 2016 , ... ... proud to announce that Dr. Julie Lombardo, PT, DPT, MA, OCS, WCS, has ... of the WPTA Private Practice Award. The WPTA Private Practice Award is awarded ...
(Date:5/4/2016)... ... May 05, 2016 , ... The talus is the part ankle ... falls, or traffic accidents can cause the talus bone to be fractured, and a ... In a first-of-its-kind procedure using 3D printing technology, internationally renowned orthopedic surgeon Dr. ...
Breaking Medicine News(10 mins):