Message #55 From:
Stock News Bot Date: November 20, 2006 06:25:00 AM
MCET News MultiCell Technologies to Seek Advanced Human Clinical Trials for Lead Therapeutics Program
SAN DIEGO--(BUSINESS WIRE)--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.