SAN DIEGO, March 26, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) announced today that it has
initiated a phase 2, clinical proof-of-concept study of MST-188 in
combination with recombinant tissue plasminogen activator (rt-PA)
in patients with acute lower limb ischemia. Acute limb
ischemia (ALI), an acute complication of peripheral arterial
disease, describes a sudden decrease in perfusion of a limb,
typically in the legs, that often threatens viability of the
limb. Patients presenting with ALI have a poor short-term
outlook, with 30-day amputation rates as high as 30% and a
mortality rate around 15%. MST-188 for the treatment of ALI
has been granted orphan drug designation by the U.S. Food and Drug
Administration.
Martin Emanuele, PhD, Senior Vice
President, Development, said: "Numerous experimental models, as
well as clinical studies, demonstrate that MST-188 facilitates
thrombolysis, repairs damaged cell membranes, and improves
microvascular blood flow. When combined with rt-PA, we
believe these activities will translate into faster thrombolysis in
patients with ALI and in other acute thrombotic events such as
stroke, while at the same time reducing vessel re-occlusion,
reperfusion injury, and tissue necrosis."
Brian M. Culley, Chief Executive
Officer, said: "Initiating the ALI study represents further
execution of our long-term strategy to maximize the value of
MST-188 through its development in multiple areas of significant
unmet medical need. I congratulate our clinical operations
team for initiating this study consistent with our guidance, while
at the same time opening 40 clinical sites in the U.S., as well as
clinical sites in multiple countries outside the U.S., in our
pivotal phase 3 EPIC study in sickle cell disease."
About the Phase 2 Study
The study will enroll
approximately 60 patients from approximately 15 sites within and
outside the U.S. with Rutherford Category IIa and IIb acute lower
limb ischemia receiving catheter-directed rt-PA and compare a high
and low dose of MST-188 against rt-PA alone. The primary objectives
are to evaluate the safety and efficacy of MST-188 in combination
with rt-PA and whether MST-188 results in more rapid thrombolysis
and tissue perfusion. Secondary objectives are to assess the
clinically-meaningful benefit of MST-188 in combination with rt-PA
by measures such as duration of thrombolytic therapy,
amputation-free survival, target limb re-interventions, and the
need for endovascular or open surgical re-interventions. These
objectives will be measured through up to 90 days of follow-up. The
study is expected to take approximately 18 months to enroll.
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, and has initiated a phase
2, clinical proof of concept study to evaluate whether MST-188
improves the effectiveness of rt-PA in patients with acute limb
ischemia. The Company also is developing MST-188 in heart
failure and plans to announce its clinical development plans in
this indication in the second half of 2014. 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 the potential of MST-188 to demonstrate
safety and efficacy in combination with rt-PA in patients with
acute limb ischemia and other acute complications of arterial
disease, such as stroke, and the Company's clinical development
plans for MST-188 in heart failure and the timing of any
announcement of such plans. 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 the Company's product candidates and
the risk that its product candidates, including MST-188, may not
demonstrate adequate safety, efficacy or tolerability in one or
more such studies, including the phase 2 study in ALI; 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 a phase 2 clinical study of MST-188
in heart failure or other indications; the potential that, even if
clinical studies of a product candidate 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 its
product candidates, including clinical studies, and regulatory
activities for its product candidates, 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 its product candidates 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 a product candidate 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 or AIR001 and
prevent competitors from duplicating or developing equivalent
versions of its product candidates; 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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SOURCE Mast Therapeutics, Inc.