SAN DIEGO, June 16, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today announced that, in line
with prior guidance, it has initiated patient enrollment in a
sub-study within EPIC, its pivotal phase 3 study of MST-188 in
sickle cell disease, to investigate and quantify the effect of
MST-188 on tissue oxygenation, which will be measured utilizing a
non-invasive, FDA-approved device.
MST-188 has been shown to reduce viscosity and adhesive
frictional forces in blood and improve microvascular blood flow.
Improvements in the flow of oxygen-carrying blood to tissues
and organs can be expected to improve tissue oxygenation, shorten
the duration of vaso-occlusive crisis, and limit tissue damage and
end-organ dysfunction and failure.
Brian M. Culley, Chief Executive
Officer, said: "Organ failure, which is the leading cause of
premature death in adults with sickle cell disease, is thought to
be the consequence of a lifetime of repeated vaso-occlusive events
and the resulting ischemia. We believe that measuring effects
on microvascular blood flow and tissue oxygenation during
vaso-occlusive crisis will be useful to understanding MST-188's
potential to improve long-term outcomes for sickle cell patients
where multi-decade, survival trials are impractical. MST-188
has already demonstrated an ability to improve microvascular blood
flow. Now, this sub-study will demonstrate whether MST-188
also improves tissue oxygenation. Together, these data will
provide insight into the potential for MST-188 to reduce end-organ
failure and associated premature death in individuals with sickle
cell disease."
About the EPIC Sub-Study
The sub-study will enroll
patients who are concurrently randomized in the EPIC clinical trial
and will be conducted at selected EPIC sites in the U.S. The
primary objective is to evaluate the effects of MST-188 on tissue
oxygenation in subjects with sickle cell disease who are
experiencing a vaso-occlusive crisis. Tissue oxygenation will
be determined using a non-invasive, U.S. Food and Drug
Administration (FDA)-approved device.
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 and conditions
typically characterized by impaired microvascular blood flow and
damaged cell membranes.
The Company is enrolling subjects in EPIC, a pivotal phase 3
study of MST-188 in sickle cell disease, and in a phase 2, clinical
study to evaluate whether MST-188 improves the effectiveness of
recombinant tissue plasminogen activator therapy in patients with
acute limb ischemia. The Company also is developing MST-188
in heart failure and expects 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 usefulness of data from the EPIC
sub-study, potential clinical benefits of MST-188 in sickle cell
disease, and the Company's development of MST-188 in other
indications, including heart failure. 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 a phase 2 clinical study of MST-188 in heart failure
or other indications; 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 potential
that, even if clinical studies of MST-188 in one indication are
successful, clinical studies in another indication may not be
successful; 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,
manufacturing, and regulatory activities, 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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