Afexa Announces Completion Of Interim Analysis On COLD-FX Pediatric Multi-Centre Clinical Trial. Medistem Inc Submits Response To FDA Clinical Hold. Print E-mail
By Staff and Wire Reports   
Friday, 26 August 2011 19:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 26, 2011.

Afexa Life Sciences Inc. (OTC:AFXSF), announced the encouraging results of an interim analysis performed by an independent data monitoring committee (IDMC) for the currently in-progress COLD-FX(R) clinical trial in a pediatric population.

The IDMC has completed a review of the data obtained to date and unanimously recommended that the study continue into the 2011/2012 cold and flu season. This multi-centre, randomized, placebo-controlled, double-blind study is investigating the potential benefits of three day dosing of COLD-FX in reducing cold and flu symptoms in children.

Recruitment of trial participants is continuing with a total of 500 children, aged 3 to 11, to be recruited from cities across Canada. Over the course of the trial, Investigators estimate that approximately 60% of these children will develop cold or flu symptoms and be eligible to enter the study. Clinical trial participants are being randomized to take either a special formulation of COLD-FX for children or a placebo for three days, and are closely monitored for 14 days.

The interim analysis was completed in a blinded fashion to evaluate the safety and efficacy and determine whether continuation of the trial was warranted. The results demonstrated a favorable trend and supported the independent recommendation to continue the trial to completion as per the study protocol.

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Medistem Inc  (OTC:MEDS) announced the Company is filing with the FDA a response to clinical hold regarding the Company's FDA Phase I clinical trial application, BB-IND 13898, entitled Allogeneic-Unrelated, Menstrual Derived, Mesenchymal Stem Cell-Like Endometrial Cells Administered Intramuscular.

The proposed clinical trial, for which Dr. Michael P Murphy from Indiana University is Principle Investigator, seeks to treat 10 patients with critical limb ischemia who have no options but amputation with the company's universal donor Endometrial Regenerative Cells (ERC).


Also Friday:


Cardium Therapeutics (NYSE Amex:CXM) today announced that Christopher J. Reinhard, Chairman and Chief Executive Officer, is scheduled to present at the Southern California Investor Conference on Monday, August 29, 2011, at 9:30 a.m. (Pacific) at the Island Hotel in Newport Beach, California.

CONMED Corporation's (NASDAQ: CNMD) CONMED Linvatec arthroscopy unit announced today the release of its New GENESYS™ Matryx® Biocomposite Interference Screw.

ICBS Ltd. (OTCPK: ICBT),  announced today that partner BioSpec Global Solutions Inc. has opened talks with a U.K. , and Chinese distributors for the TOGS product lines.

Infrared Systems International (OTCBB: IFRS) announces the completion of several internal projects and discusses corporate strategies for continued success.

Waters Corporation (NYSE:WAT) today recognized the Center for Proteomics at the Translational Genomics Research Institute (TGen) as a Waters Center of Innovation.



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