SAN DIEGO, Jan. 6, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today announced that, in a
placebo-controlled, nonclinical model of chronic heart failure,
MST-188 demonstrated a statistically significant improvement in
numerous parameters of heart function, including left ventricular
ejection fraction and end-systolic volume, stroke volume and
cardiac output. Notably, a single two-hour infusion of
MST-188 resulted in improvements that were significant immediately
(at the end of MST-188 administration) and remained significant at
one week (and, in some cases, at two weeks) after MST-188
administration.
Hani N. Sabbah, Ph.D., Professor of Medicine & Director of
Cardiovascular Research at Henry Ford Health System, said: "These
data clearly show that MST-188 improves left ventricular ejection
fraction and end-systolic volume, both of which are important
indicators of long-term mortality and morbidity in chronic heart
failure, with some effects lasting up to 2 weeks
post-infusion. The durability of response is very encouraging
and merits clinical investigation."
Santosh Vetticaden, M.D., Ph.D., Chief Medical Officer of Mast
Therapeutics, said: "Heart failure is an area of significant unmet
medical need that accounts for over 1 million hospitalizations
every year in the U.S. alone. Although there have been modest
improvements in treatment, heart failure remains associated with
significant mortality and high rates of hospital admission and
readmission. We look forward to discussing these results with
heart failure experts and potential partners and mapping our
clinical development strategy in this exciting new
indication."
The Company has submitted data from this study for presentation
at an upcoming medical conference and will provide an update on its
plans for MST-188 in heart failure later in 2014.
Details of the Study and Results
The objective of the
study was to determine the effect of acute intravenous
administration of MST-188 on left ventricular systolic and
diastolic cardiac function in a model of chronic heart failure
produced by multiple sequential intracoronary
microembolizations. A single dose of MST-188 (low or high
dose) or placebo was administered over 2 hours. Hemodynamic,
ventriculographic, echocardiographic and electrocardiographic
measurements were taken at baseline (prior to study drug
administration) and at the following time-points after the start of
study drug administration: 2 hours (end of administration), 24
hours, 1 week and 2 weeks. Peripheral venous blood samples
were obtained at the same time-points. The improvements
described above were calculated as the difference between baseline
and mean values of each study group at each time-point using a
one-way analysis of variance, with p<0.05 considered
significant. The study was conducted under the supervision of
Dr. Hani N. Sabbah at Henry Ford Health System, a Michigan non-profit corporation.
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 early 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 regarding MST-188's prospects in heart failure, the
potential market in that indication, and the Company's development
plans for MST-188 in heart failure and in acute limb ischemia,
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: 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 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; 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.
(Logo:
http://photos.prnewswire.com/prnh/20120612/LA22456LOGO-a)
SOURCE Mast Therapeutics, Inc.