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Mithridion, Inc., a biopharmaceutical company focusing on serious central nervous system (CNS) disorders, announced today results from a Phase I pharmacokinetic and clinical study of MCD-386, its lead drug candidate for Alzheimer's disease (AD). MCD-386 is an M1 selective muscarinic agonist with "first-in-class" potential for improving memory and cognition symptoms, and for disease-modifying effects (or stopping disease progression) in AD. Results of the Phase I data will be presented in a corporate overview on Wednesday, April 8 at 4:30 p.m. at the C21 BioVentures Conference taking place on April 7-9 in Napa, Calif. Dr. Trevor M. Twose, Chief Executive Officer of Mithridion Inc., will be available for one-on-one meetings.

Mithridion is developing a controlled release formulation with the dual objectives of extending the duration of action and avoiding elevated peak (Cmax) concentrations, while maintaining the MCD-386 concentration above the therapeutic level. The company plans to evaluate the safety, tolerability and pharmacokinetics of MCD-386 in a randomized, double-blind, placebo-controlled, ascending multiple-dose Phase I study to commence in the fourth quarter of 2009.

Trevor M. Twose, Ph.D., Chief Executive Officer of Mithridion Inc., commented on the results, "We are very encouraged that we fully met our objectives for this study, and are confident that the combination of the good selectivity for M1-muscarinic action seen in preclinical testing and a controlled release formulation will provide the desired therapeutic action and good safety profile for a first-in-class therapeutic. In addition to MCD-386, Mithridion is developing a pipeline of products for CNS disorders."

In preclinical tests, MCD-386 selectively activated M1-type muscarinic receptors, while maintaining a low level of M3 activity. This differentiation is important because M3 receptor activation is known to cause sweating, salivation and other unwanted side effects. At the elevated peak serum levels of MCD-386 in the highest dose cohort, this residual M3 activity may have caused the sweating and salivation. In order to avoid potential parasympathetic actions, Mithridion is developing a controlled release formulation with the dual objectives of extending the duration of action and avoiding elevated peak (Cmax) concentrations, while maintaining the MCD-386 concentration above the therapeutic level. In preclinical laboratory tests comparing MCD-386 to a previous M1 selective agonist, xanomeline, regarded as the best first-generation drug candidate, MCD-386 was shown to be superior to xanomeline, suggesting that MCD-386 may have an improved adverse event profile compared to previously tested muscarinic drugs.

In preclinical laboratory tests, MCD-386 has been evaluated in a standard AD model that mimics damaged cholinergic neuronal activity (neurons that use acetylcholine), similar to that caused by AD. Preclinical results show that MCD-386 appears to replace deficient cholinergic neuronal activity and to improve memory and cognition. In addition, MCD-386 has been shown to activate alpha-secretase enzymes, which might reduce or prevent the loss of brain cells in AD by preventing the formation of neurotoxic amyloid beta. This discovery suggests that MCD-386 may have important and unique disease-modifying properties. ... Exp Neurol. 2009 Apr 6.

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