The
patent includes claims to the use of the Company's drug candidate,
Trimesta™ (oral estriol), in conjunction with a gestagen for the
treatment of multiple sclerosis (MS) and other autoimmune diseases. The
patent also includes a claim for the administration of Trimesta™, a
gestagen and a third standard of care MS agent, such as glatiramer
acetate injection (Copaxone®), interferon beta-1a (Avonex®, Rebif®),
interferon beta-1b (Betaseron®, Extavia®) or sphingosine-1-phosphate
receptor modulator (Gilenya®). Through its wholly owned subsidiary,
Synthetic Biologics holds the exclusive license to the newly issued U.S.
Patent 8,658,627, as well as U.S. Patents 8,372,826 and 6,936,599 and
pending patents for MS and other autoimmune diseases covering the uses
of its oral estriol candidate, Trimesta™.
In
an on-going randomized, double-blind, placebo-controlled Phase II
clinical trial for the treatment of women with relapsing-remitting MS,
patients enrolled at 15 centers in the U.S. are administered either
Trimesta™ in combination with Copaxone® and progesterone (a gestagen),
or receive a placebo plus Copaxone®. Lead Principal Investigator of the
clinical trial, Rhonda Voskuhl, M.D., Professor, Department of
Neurology, Jack H. Skirball Chair in Multiple Sclerosis Research and
Director, Multiple Sclerosis Program at the UCLA School of Medicine, is
scheduled to present topline results from this trial at the American
Academy of Neurology's (AAN) 66th Annual Meeting
in Philadelphia on April 29 & 30, 2014, as part of the AAN Emerging
Science program. The clinical trial is supported by grants exceeding $8
million, awarded primarily by the National Multiple Sclerosis Society
(NMSS) in partnership with the NMSS's Southern California chapter, and
the National Institutes of Health.
"Claims
in this new patent further expand Synthetic Biologics' intellectual
property related to our oral estriol candidate, Trimesta™,
for the treatment of MS and other autoimmune diseases," stated Jeffrey
Riley, Chief Executive Officer at Synthetic Biologics. "Our objective
has been to continue to strengthen our intellectual property covering
oral estriol and this patent is an achievement in that direction."
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Labels: Avonex, Betaseron, Copaxone, Extavia, Rebif
