CLINICAL DEVELOPMENT & SUPPORT SERVICES LTD (CDSS) HAS
BEEN RETAINED BY MULTICELL TECHNOLOGIES TO MANAGE
MCT-125 PHASE IIb CLINICAL TRIAL
MACCLESFIELD, Cheshire, England, June 18, 2010 — Clinical Development & Support Services, Ltd. (CDSS) of Cheshire, England has been retained by MultiCell Technologies, Inc. based in Woonsocket, RI, USA to manage its planned Phase IIb clinical trial in the United Kingdom for MCT-125, the Company’s lead drug candidate for treatment of primary multiple sclerosis-related fatigue (PMSF).
About Clinical Development & Support Services, Ltd.
Clinical Development & Support Services, Ltd. (CDSS) provides a wide range of clinical development services to the pharmaceutical, biotechnology and medical device industries. CDSS is a clinical research organisation (CRO) specialising in the management of clinical trials including the provision of study site coordination/research nursing services. CDSS manages all phases of clinical development from the first administration of drugs in humans through to post-marketing studies. For more information about CDSS, please visit http://www.cdssltd.com.
About MultiCell Technologies, Inc.
MultiCell Technologies, Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and discovery tools that address unmet medical needs for the treatment of neurological disorders, hepatic disease and cancer. For more information about MultiCell Technologies, please visit http://www.multicelltech.com.
In an earlier Phase IIa study, MCT-125 was tested on 138 patients suffering from PMSF. MCT-125 was shown to be effective within 4 weeks of administration, was active across all multiple sclerosis (MS) disease severity assessment scales, and on patients regardless of MS disease sub-type (primary progressive, secondary progressive and relapsing-remitting).
MCT-125 is a fixed dose, orally delivered, combination therapeutic acting on noradrenergic neurons and tyrosine hydroxylase to block the reuptake of noradrenaline with little or no direct action on serotoninergic neurons. The synthesis of noradrenaline in noradrenergic neurons is tightly regulated by tyrosine hydroxylase acting as the key rate-limiting step. MCT-125 is thought to lead to the greater availability of noradrenaline in the central nervous system resulting in a decrease in fatigue levels.
Multiple sclerosis is an autoimmune disease in which immune cells attack and destroy the myelin sheath insulating neurons in the brain and spinal cord.
Approximately 350,000 individuals have been diagnosed with MS in the United States, and more than two million persons worldwide are afflicted with this disease. An estimated 10,000 new MS cases are diagnosed in the USA annually.
PMSF comes on suddenly, and is overwhelming in proportion to any activity undertaken. PMSF can severely affect an MS patient’s quality of life, ability to function, and ability to feel they have control over their illness. MS patients with PMSF experience an overwhelming tiredness, lack of energy, and a feeling of exhaustion. The causes of fatigue in MS are thought be partly the result of the disease process itself, and partly the result of other factors (secondary fatigue) that affect a person with MS more significantly than people without the disease. PMSF affects over 70% of persons with MS. Pharmacological treatment options for PMSF are limited, and no drug has been specifically approved by the U.S. Food and Drug Administration for the treatment of PMSF.
Caution Regarding Forward-Looking Statements
Any statements in this press release about CDSS’ 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 programs. CDSS 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 anticipated clinical development milestones might not be achieved, regulatory approval may not be received, or successful commercialisation of the products may not be as expected, the market for the products may not grow as expected, and the risk that the 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-K for the fiscal year ended November 30, 2009, 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.
Clinical Development & Support Services Ltd (CDSS)
John Illingworth, Managing Director
+44 1625 617447