Fatigue drug

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Fatigue drug

Postby bromley » Wed Oct 25, 2006 10:11 am

MultiCell Establishes Clinical Development Team to Lead UK Phase IIb Human Clinical Trials for MCT-125 for the Treatment of Fatigue in MS Patients

MultiCell Technologies, Inc, a developer of therapeutics for the treatment of degenerative neurological diseases, metabolic and endocrinological disorders, and infectious diseases, has established the clinical development team that will spearhead the next phase of human clinical trials to further evaluate the Company's lead drug candidate MCT-125 for the treatment of the chronic fatigue in multiple sclerosis (MS) patients.
Following highly encouraging results in earlier clinical trials, MultiCell is preparing to advance MCT-125 to Phase IIb human clinical trials in the United Kingdom. MCT-125 is being developed for the treatment of fatigue which is the most common symptom of MS - a symptom for which no approved drugs currently exist.

"We have recruited a team of very skilled clinicians, regulatory affairs and GMP development and manufacturing personnel to help drive the next phase of our MCT-125 clinical trials," said Stephen M. Chang, Ph.D., Chief Executive Officer of MultiCell. "The fact that these leading experts were eager to join the program is itself an important validation of the promise of MCT-125 to someday help multiple sclerosis patients around the world."

The United Kingdom team will include Graham Cooper, MD, Adam Wooley, M.Sc. DABT FRCPath Cbiol MIBiol and Fiona MacLeod. Dr. Cooper, former Medical Director at Scotia Pharmaceuticals, Ltd., has been appointed consulting UK Medical Director. Mr. Wooley, former Director of Toxicology/Pathology at Quintiles, Scotland, has been appointed consulting ADME/Tox Director. Ms. MacLeod, regulatory affairs consultant and former Director of Regulatory Affairs at Controlled Therapeutics, has been appointed consulting UK Regulatory Affairs consultant.

The United States-based team will include David A. Shapiro, MD, Carol Gloff, Ph.D., and Mark Hanamoto. Dr. Shapiro is currently President of Integrated Quality Resources (IQR), and a Senior Consultant at Scripps Clinic. Prior to joining IQR, Dr. Shapiro was Vice President Clinical Research for Gensia, Inc., and prior to joining Gensia, was Director Hypertension Clinical Research for Merck & Co. Dr. Shapiro has been appointed consulting US Medical Director. Dr. Gloff, President of C. Gloff & Associates, regulatory affairs consultancy, has been appointed US Regulatory Affairs Consultant. Dr. Gloff previously was Vice President, Chief Regulatory Officer for Immunogen Corporation. Prior to joining Immunogen, Dr. Gloff was Vice President Regulatory Affairs for Alkermes, Inc. Mr. Hanamoto, former Director of Development for GeoMed and Vivus, has been appointed GMP drug Development and Manufacturing Consultant.

MCT-125 targets fatigue associated with MS, an autoimmune disease in which immune cells attack and destroy the myelin sheath protecting neurons in the brain and spinal cord. About two million people worldwide are afflicted with MS, and approximately 70 percent of them report fatigue as the worst symptom of their disease.

In a 138 patient, multi-center, double-blind placebo controlled Phase II clinical trial conducted in the UK by Amarin, MCT-125 (then known as LAX-202) demonstrated efficacy in significantly reducing the levels of fatigue in all MS patient populations enrolled in the study including relapse-remitting, secondary progressive and primary progressive. Patients enrolled in the Phase II trial conducted by Amarin reported few if any side effects following daily oral dosing of LAX-202. MultiCell intends to proceed with the anticipated pivotal Phase IIb trail of MCT-125 using the data generated by Amarin for LAX-202 following discussions with the FDA and Medicines and Healthcare Products Review Agency UK (MHRA). If MCT-125 is approved for the treatment of fatigue in MS patients by the FDA, MHRA, and other such regulatory agencies, and is successfully commercialised, MultiCell estimates MCT-125 could generate up to $3 billion in cumulative worldwide sales during the time MCT-125 is under patent protection.

Source: MultiCell Technologies, Inc.
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