Still Alive, MultiCell (MCET.OB), MCT-125 Phase IIb Clinical Trial
MCET.OB has retained Clinical Development & Support Services, Ltd. (CDSS) of Cheshire, England to manage its …planned … Phase IIb clinical trial in the UK for MCT-125; their lead drug candidate for treatment of primary multiple sclerosis-related fatigue (PMSF).
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 US, and more than 2 M 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 US’ FDA for the treatment of PMSF.
