Monday, November 20, 2006
SAN DIEGO--(BUSINESS WIRE)--Nov 20, 2006 - MultiCell Technologies, Inc. (OTCBB:MCET), developing first-in-class drugs based on advanced immune system modulation and other proprietary technologies, today announced that it will seek allowance to proceed from the Medicines and Healthcare Products Regulatory Agency ("MHRA") in the UK for its planned Phase IIb MCT-125 human clinical trial for the treatment of chronic fatigue in multiple sclerosis patients.
MultiCell has scheduled a meeting with the MHRA for December 1, 2006 to present the Company's clinical development plan for MCT-125. Additionally, the Company will request that the MHRA allow the Company to proceed to enroll patients in a proposed Phase IIb clinical trial to determine the minimum efficacious therapeutic dose for MCT-125.
"We are hopeful MCT-125 will become an important therapy available to the millions of patients suffering from Primary Multiple Sclerosis-related Fatigue (PMSF)," said Dr. Stephen M. Chang, Chief Executive Officer of MultiCell. "The purpose of the proposed Phase IIb dose-ranging trial is to determine the minimum efficacious dose for MCT-125 prior to commencing a pivotal Phase III trial. The initial Phase II trial conducted by Amarin only determined a single efficacious dose, and we need to know a range over which MCT-125 will remain effective," noted Dr. Chang.
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.
MultiCell recently announced that it has established the clinical development team that will spearhead the next phase of human clinical trials.
The MHRA (http://www.mhra.gov.uk) is the UK equivalent of the US Food and Drug Administration ("FDA"), and is the government agency responsible for approving the sale of all new drug therapeutics in the UK.
About MultiCell Technologies, Inc.
MultiCell Technologies, Inc. is an integrated biopharmaceutical company committed to the development of breakthrough therapeutics based on a portfolio of therapeutic candidates and patented drug development technology. MultiCell's drug development program is focused on modulation of the immune system.
MultiCell's therapeutic pipeline includes drug candidates some of which are in various advanced stages of human clinical trials. These therapies include:
-- MCT-125 for the treatment of chronic fatigue in MS patients. MCT-125 completed a Phase II clinical trial and demonstrated significant efficacy in reducing chronic fatigue in MS patients. There is no drug specifically approved for the treatment of chronic fatigue in MS patients anywhere in the world.
-- MCT-175 for the treatment of relapsing-remitting MS. MCT-175, in preclinical development for the treatment of relapsing-remitting MS, targets disease specific autoaggressive T-cells that destroy the myelin sheath of nerve cells. MCT-175 successfully ameliorated the disease in animal models.
-- MCT-275 for the treatment of type-1 diabetes. MCT-275, in preclinical development, targets disease-specific autoaggressive T-cells that destroy insulin producing cells in the pancreas. MCT-275 completely reversed the type-1 diabetic phenotype and prolonged life in animal models.
-- MCT-465 in an adjuvant therapy for the treatment of virus infection and cancer. MCT-465, in preclinical studies, successfully reduced pulmonary influenza virus levels 1,000-fold in animal models, and has demonstrated effectiveness in reducing virus levels of HIV and HCV in animal models. MCT-465, in preclinical studies, successfully eliminated certain types of tumors in animal models.
The Company also holds unique cell-based technology for use in drug discovery screening applications, and is a leading producer of the cell lines needed by the biotechnology industry to develop new drugs and therapeutics. For more information about MultiCell Technologies, please visit http://www.multicelltech.com.
MultiCell Technologies, Inc.
Dr. Stephen Chang, CEO, 619-743-3806