SAN DIEGO, Feb. 24, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today announced that,
consistent with its prior guidance, it has initiated international
enrollment in EPIC, its pivotal phase 3 study of MST-188 in sickle
cell disease, with clinical sites now open in multiple foreign
jurisdictions with high rates of hospitalization for sickle cell
disease. The Company previously reported that it had met its
goal of having 40 U.S. sites open by the end of 2013 and is
on-track to opening an additional 30 sites outside of the U.S. by
the end of 2014.
"I congratulate our clinical operations team for continuing to
execute our EPIC development plan on schedule and consistent with
our announced timelines," said Brain M.
Culley, Chief Executive Officer of Mast Therapeutics.
"I have met with many of our investigators, both within and outside
the U.S., and they are enthusiastic about the potential for MST-188
to become the first agent that reduces the duration of
vaso-occlusive crisis in patients with sickle cell disease.
We look forward to building on this momentum, opening new sites and
completing enrollment by the end of 2015."
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The
Company is leveraging the MAST (Molecular Adhesion and Sealant
Technology) platform, derived from over two decades of clinical,
nonclinical and manufacturing experience with purified and
non-purified poloxamers, to develop MST-188, its lead product
candidate, for serious or life-threatening diseases with
significant unmet needs. MST-188 is a cytoprotective,
hemorheologic, anti-inflammatory and anti-thrombotic agent that has
potential utility in diseases or conditions characterized by
microcirculatory insufficiency (endothelial dysfunction and/or
impaired blood flow).
The Company is enrolling subjects in EPIC, a pivotal phase 3
study of MST-188 in sickle cell disease. In the first quarter
of 2014, the Company plans to initiate a phase 2, clinical proof of
concept study in acute limb ischemia that will evaluate whether
MST-188 improves the effectiveness of existing thrombolytic
agents. The Company also is evaluating development options in
heart failure. More information can be found on the Company's
web site at www.masttherapeutics.com. (Twitter:
@MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast
Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions
you that statements included in this press release that are not a
description of historical facts are forward-looking statements that
are based on the Company's current expectations and assumptions.
Such forward-looking statements include, but are not limited to,
statements relating to progress with and completion and potential
success of the EPIC study, prospects for MST-188 in sickle cell
disease, and the Company's development plans for MST-188 in acute
limb ischemia and heart failure, including the timing of initiation
of any clinical studies. Among the factors that could cause
or contribute to material differences between the Company's actual
results and the expectations indicated by the forward-looking
statements are risks and uncertainties that include, but are not
limited to: the uncertainty of outcomes in ongoing and future
studies of MST-188 and the risk that MST-188 may not demonstrate
adequate safety, efficacy or tolerability in one or more such
studies, including EPIC; delays in the commencement or completion
of clinical studies, including as a result of difficulties in
obtaining regulatory agency agreement on clinical development plans
or clinical study design, opening trial sites, enrolling study
subjects, manufacturing sufficient quantities of clinical trial
material, being subject to a "clinical hold," and/or suspension or
termination of a clinical study, including due to patient safety
concerns or lack of funding; the potential for institutional review
boards or the FDA or other regulatory agencies to require
additional nonclinical or clinical studies prior to initiation of
any planned phase 2 clinical study of MST-188; the potential that,
even if clinical studies of MST-188 in one indication are
successful, clinical studies in another indication may not be
successful; the risk that, even if clinical studies are successful,
the FDA or other regulatory agencies may determine they are not
sufficient to support a new drug application; the Company's
reliance on contract research organizations (CROs), contract
manufacturing organizations (CMOs), and other third parties to
assist in the conduct of important aspects of development of
MST-188, including clinical studies, and regulatory activities for
MST-188, and that such third parties may fail to perform as
expected; the Company's ability to obtain additional funding on a
timely basis or on acceptable terms, or at all; the potential for
the Company to delay, reduce or discontinue current and/or planned
development activities, including clinical studies, partner MST-188
at inopportune times or pursue less expensive but higher-risk
and/or lower return development paths if it is unable to raise
sufficient additional capital as needed; the risk that, even if the
Company successfully develops MST-188 in one or more indications,
it may not realize commercial success with its products and may
never generate revenue sufficient to achieve profitability; the
risk that the Company is not able to adequately protect its
intellectual property rights relating to the MAST platform and
MST-188 and prevent competitors from duplicating or developing
equivalent versions of its product candidates, including MST-188;
and other risks and uncertainties more fully described in the
Company's press releases and periodic filings with the Securities
and Exchange Commission. The Company's public filings with the
Securities and Exchange Commission are available at
www.sec.gov.
You are cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date when made. Mast
Therapeutics does not intend to revise or update any
forward-looking statement set forth in this press release to
reflect events or circumstances arising after the date hereof,
except as may be required by law.
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http://photos.prnewswire.com/prnh/20120612/LA22456LOGO-a)
SOURCE Mast Therapeutics, Inc.