Tuesday, February 06, 2007
SAN DIEGO--(BUSINESS WIRE)--Feb 6, 2007 - MultiCell Technologies, Inc. (OTCBB:MCET), 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.
MultiCell Technologies, Inc.
Dr. Stephen Chang, CEO, 401-333-0610