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MultiCell Technologies to Seek Advanced
Human Clinical Trials for Lead Therapeutics Program
Company Seeks Allowance from MHRA to Proceed
with Phase IIb Clinical Trial for Breakthrough
Fatigue Fighting Multiple Sclerosis Drug
SAN
DIEGO--(BUSINESS WIRE)--MultiCell Technologies,
Inc. (OTCBB:MCET
- News), 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.
Contact:
MultiCell Technologies, Inc.
Dr. Stephen Chang
MCETInvestor@MultiCelltech.com
or
Trilogy Capital Partners (Financial Communications)
Paul Karon, 800-592-6067
paul@trilogy-capital.com
Source: Business Wire (Monday November 20, 9:25 am ET)
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