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MultiCell Technologies Announces Progress for MCT-125's Anticipated
Phase IIb Clinical Trial
Meeting with British Health Authorities Allows
Company to Further Clinical Trials for Lead Therapeutics Program Targeting
Multibillion Dollar Worldwide Market
SAN
DIEGO--(BUSINESS WIRE)--MultiCell Technologies,
Inc. (OTCBB:MCET
- News), developing
first-in-class drugs based on advanced immune system modulation
technologies, announced today it has received the formal Minutes from its
December 1, 2006 milestone meeting with the Medicines and Healthcare
Products Regulatory Agency UK (MHRA). The MHRA meeting cleared the way for MultiCell to prepare and submit the Clinical Trial
Authorization (CTA) application, retain the MS centers where the clinical
study will be conducted, and complete the manufacturing and formulation
procedures for the Company's lead therapeutics program, MCT-125.
If MCT-125 is approved
for the treatment of fatigue in MS patients by the MHRA, the FDA, and other
such regulatory agencies, and is successfully commercialized, MultiCell estimates MCT-125 could generate up to $3
billion in cumulative worldwide sales during the time MCT-125 is under
patent protection.
"The MHRA was very
helpful in clarifying that our current preclinical data package and
proposed clinical trial design is acceptable, which allows us to prepare
and file our CTA application," said Dr. Stephen Chang, President and
Chief Executive Officer of Multicell
Technologies. "The results from this meeting are significant since
MHRA stated we do not have to conduct additional preclinical testing of
MCT-125 prior to filing our application requesting allowance to proceed
with our planned Phase IIb clinical trial."
The purpose of the
meeting with MHRA was to present the Company's proposed clinical
development plan for MCT-125 for the treatment of chronic fatigue in
multiple sclerosis (MS) patients, and to seek guidance from MHRA with
respect to the proposed Phase IIb clinical trial
design and accompanying preclinical data package.
In an earlier 138 patient, multi-center, double-blind placebo controlled
Phase II clinical trial conducted in the UK by Amarin
Corporation, MCT-125 (then known as LAX-202) demonstrated efficacy in
reducing the levels of fatigue in MS patients enrolled in the study.
MCT-125 proved to be effective within 4 weeks of the first daily oral
dosing, and showed efficacy in MS patients who were moderately as well as
severely affected. MCT-125 demonstrated efficacy in all MS patient
sub-populations including relapsing-remitting, secondary progressive and
primary progressive.
MultiCell is an innovator in the science
of modulating the human immune system with unique platform technologies,
focusing on the development of breakthrough drugs to treat serious
diseases, including multiple sclerosis, type-1 diabetes, influenza, and
cancer.
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-175 for the treatment of
relapsing-remitting MS.
- MCT-275 for the treatment of
type-1 diabetes.
- MCT-465 in an adjuvant
therapy for the treatment of virus infection and cancer.
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. For more information about MultiCell Technologies, please visit http://www.multicelltech.com.
For investor information
about MultiCell, please visit http://www.trilogy-capital.com/tcp/multicell.
Caution Regarding
Forward-Looking Statements
Any statements in this
press release about MultiCell's expectations,
beliefs, plans, objectives, assumptions or future events or performance are
not historical facts and are forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995 (the "Act").
These statements are often, but not always, made through the use of words
or phrases such as "believe," "will,"
"expect," "anticipate," "estimate,"
"intend," "plan," "forecast,"
"could," and "would." Examples of such forward looking
statements include statements regarding the timing, design, scope, and
anticipated results of our clinical development of MCT-125. MultiCell bases these forward-looking statements on
current expectations about future events. They involve known and unknown
risks, uncertainties and assumptions that may cause actual results, levels
of activity, performance or achievements to differ materially from those
expressed or implied by any forward-looking statement. Some of the risks,
uncertainties and assumptions that could cause actual results to differ
materially from estimates or projections in the forward-looking statement
include, but are not limited to, the risk that we might not achieve our
anticipated clinical development milestones, receive regulatory approval,
or successfully commercialize MCT-125 as expected, the market for our
products will not grow as expected, and the risk that our products will not
achieve expectations. For additional information about risks and
uncertainties MultiCell faces, see documents MultiCell files with the SEC, including MultiCell's report on Form 10-KSB for the fiscal year
ended November 30, 2005, and all our quarterly and other
periodic SEC filings. MultiCell claims the
protection of the safe harbor for forward-looking statements under the Act
and each assume no obligation and expressly disclaim any duty to update any
forward-looking statement to reflect events or circumstances after the date
of this news release or to reflect the occurrence of subsequent events.
Contact:
MultiCell Technologies, Inc.
Dr. Stephen Chang, 858.200.0598
MCETInvestor@MultiCelltech.com
or
SmallcapInsights.com
Dr. John Faessel, 858-587-8590
editors@smallcapinsights.com
or
Trilogy Capital Partners (Financial Communications)
Paul Karon, 800-592-6067
paul@trilogy-capital.com
Source: Business Wire (Tuesday February 6, 3:30 am ET)
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