SAN DIEGO, Sept. 28, 2015 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage
biopharmaceutical company leveraging its molecular adhesion and
sealant technology (MAST) platform to develop novel therapies for
sickle cell disease, heart failure, and stroke, today announced
that data from a nonclinical study of vepoloxamer, its lead product
candidate, will be presented at the 19th Annual Scientific Meeting
of the Heart Failure Society of America (HFSA). The oral
presentation will be given by Dr. Hani N. Sabbah, Professor of
Medicine and Director of Cardiovascular Research at Henry Ford
Health System, at 12:15 p.m. ET
today. The HFSA conference is being held at the Gaylord National
Resort & Convention Center in National Harbor, Maryland, September 26
through September 29, 2015.
In the study, isolated failing cardiomyocytes from an animal
model of chronic heart failure were treated in vitro for two
hours with low or high-dose vepoloxamer or placebo control.
Treatment with vepoloxamer was associated with a significant,
dose-dependent reduction in intracellular calcium concentration
compared to control. These results indicate that vepoloxamer,
through its membrane-sealing activity, can limit unregulated
calcium entry into failing cardiomyocytes in a dose-dependent
manner, which may limit or prevent calcium overload.
Dr. Sabbah said: "Microscopic sarcolemmal membrane disruptions
have been described in cardiomyocytes of the failing heart and are
believed to be responsible for unregulated calcium entry into the
cell, which contributes to calcium overload, a key abnormality
responsible for ongoing cardiomyocyte dysfunction and death in
heart failure. These results indicate that the membrane-sealing
properties of vepoloxamer may help restore damaged cardiac cell
membrane integrity, thus minimizing calcium overload injury,
preserving cardiomyocytes, and directly improving LV
contractile function."
Dr. R. Martin Emanuele, the
Company's Senior Vice President, Development, said: "We believe the
activity of vepoloxamer in preventing unregulated calcium entry
into failing cardiomyocytes is unique, and may offer a new
mechanistic approach for heart failure patients. Also, because of
its unique mechanism, vepoloxamer should be additive to existing
therapies. We look forward to further demonstrating vepoloxamer's
potential through our Phase 2 clinical trial in chronic heart
failure."
Presentation Information:
- An oral presentation entitled "In-Vitro Exposure of Isolated
Failing Cardiomyocytes to Vepoloxamer (Purified Poloxamer 188)
Limits Unregulated Calcium Entry into the Cell" will be given by
Dr. Sabbah at 12:15 p.m. ET today,
September 28, 2015, at the Gaylord
National Resort & Convention Center, National Harbor,
Maryland.
- A copy of the presentation slides will be available after
12:15 p.m. ET on the Company's
website at:
http://www.masttherapeutics.com/technology/publications/
Other Nonclinical Studies of Vepoloxamer in Heart
Failure
The Company previously reported results from two
randomized, placebo-controlled nonclinical studies of vepoloxamer
in a model of chronic heart failure produced by intracoronary
microembolizations. In the first study, a single, two-hour
administration of vepoloxamer resulted in robust improvements in
key parameters of heart function, including left ventricular (LV)
end-systolic volume, ejection fraction, stroke volume and cardiac
output, which persisted for one to two weeks. In the second
study, vepoloxamer was administered at the start of the study and a
repeat treatment was administered three weeks after the first. The
study concluded after a total of six weeks. The second study
not only reproduced the treatment effect of the first study, but
also showed that retreatment with vepoloxamer at three weeks after
the initial administration improved upon the effects observed after
the first administration. The effects observed after the
second administration persisted for at least three weeks, until the
end of the six-week study. Notably, after the second
administration, LV ejection fraction had not returned to baseline
values by the end of the study, but was still improved by
approximately 20% above baseline. Vepoloxamer had no statistically
significant effect on heart rate or blood pressure compared to
control.
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The
Company is leveraging its MAST platform, derived from over two
decades of clinical, nonclinical and manufacturing experience with
purified and non-purified poloxamers, to develop vepoloxamer (also
known as 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 also developing AIR001, a sodium
nitrite solution for inhalation via nebulizer, for the treatment of
heart failure with preserved ejection fraction (HFpEF).
Vepoloxamer is an investigational new drug being tested in a
pivotal Phase 3 study called EPIC for the treatment of
vaso-occlusive crisis in patients with sickle cell disease.
AIR001 is an investigational new drug being tested in multiple
institution-sponsored Phase 2a studies in patients with HFpEF. 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 prospects for successful development of
vepoloxamer as a treatment for heart failure patients and
anticipated timing of achievement of development milestones, such
as commencement of 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 the Company's product candidates and
the risk that its product candidates, including vepoloxamer, 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
additional nonclinical or clinical studies to be required prior to
initiation of a planned clinical study; the risk that, even if
planned 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 a product candidate 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 its product candidates, including
clinical studies, manufacturing, 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
and may never achieve profitability; the risk that the Company is
not able to adequately protect its intellectual property rights and
prevent competitors from duplicating or developing equivalent
versions of its product candidates or that the use or manufacture
of its products or product candidates infringe the proprietary
rights of others; 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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