M´s Science Corporation (MSC), a clinical stage discovery and
development company announced today that it initiated a Phase 2 study
in Europe with its lead product SA4503 for treatment of stroke.
Earlier this year, MSC announced the initiation of a Phase 2 trial
with SA4503 for the treatment of major depression.
This latest Phase 2 trial is an international, multi-center,
double-blind and placebo-controlled study of SA4503 in patients with
stroke with a planned enrollment of approximately 60 patients. The
primary objective of the study is to evaluate safety of SA4503 in this
patient population.
SA4503 is a potent and selective agonist of the sigma-1 receptor.
Activation of this receptor is associated with enhancement of recovery
in experimental models of stroke. SA4503 induces neuroregeneration and
facilitates the recovery of damaged tissues from stress or
ischemia-induced insults. This novel mechanism of action allows for a
large time-window of treatment initiation in patients up to 60 hours
after occurrence of stroke. In contrast, thrombolytic treatment must
be applied within 3 hours after stroke, which limits the application
of this therapy to less than 10% of all stroke patients. Therefore,
SA4503 may address a significant medical need for effective stroke
therapy with an expanded time-window of treatment initiation.
Consequently, a larger proportion of stroke patients may potentially
benefit from a therapy with SA4503.
"The role of the sigma-1 receptor in enhancing recovery from
stroke was discovered by a functional genomics approach. SA4503 is
among the first therapies acting on the central nervous system that
resulted from the application of this innovative technology,"
commented Dr. Roman Urfer, Senior Vice President International
Development.
"Stroke poses significant therapeutic challenges. SA4503 with its
unique and unexploited mechanism has the potential to address the
limitations of today´s stroke therapies," said Dr. Shiro Mita,
Chairman and CEO.
"This trial marks an important milestone in the development of
SA4503. Our two on-going Phase 2 trials document our focused clinical
development with this innovative compound. Moreover, our lead in the
sigma-1 receptor field allows us to aggressively pursue this novel
mechanism of action in additional indications," commented Mr. Akihiko
Shimauchi, President and COO.
About M´s Science Corporation
M´s Science (MSC) is a privately held biopharmaceutical company
dedicated to the discovery and development of treatments of central
nervous system (CNS) disorders and cancer. MSC currently develops two
clinical stage products, SA4503 and HF10.
SA4503 is a potent and selective agonist of the sigma-1 receptor.
MSC will initially focus its clinical development of SA4503 on the
treatment of major depression and on the enhancement of recovery from
stroke.
HF10 is a natural isolate of an attenuated herpes simplex virus
and possesses strong tumor killing ability. MSC initially develops
HF10 for the treatment of head & neck cancer and intends to expand its
application to other cancers.
