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FDA Grants Orphan Drug Designation for Mithridion's MCD-386CR to Treat Progressive Supranuclear Palsy
Date:5/8/2011

ng disease targets in addition to PSP have been identified and are currently being evaluated.  The company believes that it will be able to create additional high value and strong entry barriers through this strategy, which it intends to fund using a combination of equity capital and non-dilutive funding.  Furthermore, the company believes that it can reduce clinical trial costs and improve its ability to demonstrate proof-of-efficacy for its candidate drugs by selecting for clinical trials neurological disorders, such as PSP, with more "pure play" pathogenesis or symptoms, and by using novel biomarkers and neuropsychological tests specific for particular domains of cognition, such as executive functions.

The announcement coincides with the 6th Annual Neurotech Investing and Partnering conference being held at the St. Regis Hotel in San Francisco, CA, on May 9-10, 2011, at which Trevor Twose will be available to discuss this and other developments at Mithridion.

MCD-386 is a highly selective agonist (activator) for M1-type acetylcholine muscarinic receptors, effectively mimicking acetylcholine in a selective way to achieve desired therapeutic effects while minimizing side effects.  Acetylcholine is a chemical 'neurotransmitter' vitally involved in maintaining brain health and in many brain functions such as memory, cognition, executive functions, and attention.  MCD-386 was designed to stimulate these and other key brain functions that have been compromised by the deficit of acetylcholine that is a characteristic feature of PSP.  

MCD-386 has completed Phase I single- and multi-dose clinical trials in 55 healthy volunteers, including 29 subjects who received a controlled release tablet formulation.  MCD-386CR has so far proven to be well-tolerated at the doses tested.  Extensive pharmacokinetic information obtained during the trials demonstrated sustained release of drug substance from the formulation, and, tog
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SOURCE Mithridion, Inc.
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