MADISON, Wis., May 9, 2011 /PRNewswire/ — Mithridion, Inc., a
privately-owned clinical stage drug development company focusing on
serious Central Nervous System (CNS) disorders, announces that the
U.S. Food and Drug Administration (FDA) has awarded Orphan Drug
designation for MCD-386CR, its lead drug candidate, for the
treatment of Progressive Supranuclear Palsy (PSP).
Orphan status entitles Mithridion to seven years of market
exclusivity upon approval of MCD-386 for treating PSP, and to apply
for grant funding to contribute to clinical trial costs, tax
credits, and a waiver of certain FDA fees. Orphan status is
intended to encourage the development of drugs for diseases
affecting fewer than 200,000 persons in the USA.
PSP is a progressive brain disease in which neurons degenerate
in regions of the brain vital for eye movements, balance, walking,
speech, and cognition. Cognitive impairment typically
involves slowed thinking, and difficulties with reasoning,
planning, and shifting between tasks, caused by dysfunction of the
brain’s executive functions. This has been called
“dysexecutive syndrome.”
“Orphan status will help us immeasurably to bring together the
resources and support needed to evaluate MCD-386CR in this rare but
important disease, and indeed in other devastating brain diseases
for which there are no current therapies,” said Trevor M. Twose,
Ph.D., the company’s Chief Executive. “Based on results in
preclinical studies, we believe MCD-386CR potentially will help
restore cognition, so vital to human functioning, and potentially
could treat the underlying processes causing the degeneration of
neurons in PSP.”
As a part of its recently-articulated strategy, Mithridion is
actively exploring opportunities to develop its drug candidates in
niche market opportunities in serious CNS or brain disorders, in
addition to more common diseases, such as Alzheimer’s disease and
schizophrenia. Several promisi
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