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:2/4/2016)... LONDON , Feb. 4, 2016 ... Summary Global Markets Direct,s, ,Wegener Polyangiitis - ... the Wegener Polyangiitis,s therapeutic pipeline. This report ... Wegener Polyangiitis, complete with comparative analysis at various ... action (MoA), route of administration (RoA) and molecule ...
(Date:2/4/2016)... , Feb. 4, 2016 Summary ... common cancer and the most common cancer in women ... the disease exceedingly prevalent. The number of women diagnosed ... decades, but the number of deaths has declined due ... cancer treatment has been revolutionized in the past four ...
(Date:2/4/2016)... 4, 2016 Frontier Pharma: Chronic Obstructive ... Innovation Chronic Obstructive Pulmonary Disease ... inflammation of the airways and lungs. Persistent breathing ... the disease one of the leading causes of ... the world. COPD is linked to cumulative exposure ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... 05, 2016 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... Tasting Event at the La Gorce Country Club in Miami Beach on March ...
(Date:2/5/2016)... ... 2016 , ... Regular gym users know the routine: each January, they see ... the treadmills. It’s a predictable trend. After the excesses of November and December, people ... by joining gyms, starting new walking or running routines, or signing up for Zumba. ...
(Date:2/5/2016)... New York, New York (PRWEB) , ... February 05, 2016 , ... ... (APDA) announced the election of Patrick McDermott as Chairman of the National Board of ... welcome Pat as Chairman of the Board,” stated Leslie A. Chambers , APDA ...
(Date:2/5/2016)... CA (PRWEB) , ... February 05, 2016 , ... ... Move from on one drop zone to the next using Colorize's dynamic moving camera. ... any project. This package includes a 3D slideshow environment with 1 to 5 focus ...
(Date:2/5/2016)... , ... February 05, 2016 , ... ... for Patients with Rare Diseases, a continuing medical education (CME) event presented by ... first of its kind—and a first for ACCORD, whose mission is to provide ...
Breaking Medicine News(10 mins):