SAN DIEGO, Dec. 9, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage
biopharmaceutical company, today provided details of its plan to
develop vepoloxamer (MST-188), its lead product candidate, in heart
failure.
Consistent with prior guidance, earlier this year, Mast
Therapeutics submitted an Investigational New Drug application
(IND) to the U.S. Food and Drug Administration (FDA), together with
the protocol for a Phase 2 clinical study in patients hospitalized
for acute decompensated heart failure. FDA has completed its
30-day safety review and informed the Company that it may proceed
with its proposed clinical study. The Company is finalizing
the study protocol and expects to begin recruiting patients in the
Phase 2 study in the first half of 2015.
Brian M. Culley, Chief Executive
Officer, said: "Since we first announced data from our nonclinical
proof-of-concept study in the first quarter, vepoloxamer data has
been presented at meetings of the European Society of Cardiology,
the Heart Failure Society of America and the American Heart
Association. Interest from the leading medical conferences and
thought leaders in this field reflects the potentially novel way
that vepoloxamer may improve heart failure. We believe its
membrane-sealing activity helps restore damaged cardiac cell
membranes, thus minimizing calcium overload injury, preserving
cardiomyocytes and directly improving heart contractility
and function. In contrast to most approved drugs, which have
not been shown to improve long-term outcomes, by salvaging cardiac
tissue, vepoloxamer may have the potential to reduce the high rates
of near-term hospital readmission and mortality associated with
heart failure hospitalization."
Mr. Culley continued: "Our planned study will evaluate the
safety and efficacy of multiple doses of vepoloxamer in patients
hospitalized for acute decompensated heart failure, including its
effect on markers of cardiac injury (troponin) and wall stress
(NT-proBNP), as well as clinical outcomes. As demonstrated by
our rapid progress in this area of significant unmet medical need,
we continue to identify new ways to create additional value from
our vepoloxamer franchise."
About Heart Failure
Heart failure is a chronic,
progressive condition in which heart muscle is unable to pump
sufficient blood to meet the body's needs. It is estimated that
more than 20 million worldwide, including five to six million in
the U.S., suffer from heart failure, which is the most common
diagnosis for hospital admission in the U.S. for patients over age
65. The American Heart Association estimates that total medical
costs of heart failure in the U.S. will increase from approximately
$21 billion in 2012 to approximately
$53 billion in 2030, with the
majority (80%) of such costs related to hospitalization.
About Vepoloxamer
In March
2014, the Company announced that the United States Adopted
Names (USAN) Council assigned "vepoloxamer" as the unique
non-proprietary (generic) name for the active pharmaceutical
ingredient (API) in MST-188. The Company sought a unique name for
its API to clearly identify it as different from non-purified
poloxamers. In support of its application, the Company
submitted proprietary data showing that drug products containing
non-purified poloxamers may have serious toxicity consequences and
should not be substituted for or confused with MST-188.
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 vepoloxamer (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 vepoloxamer in sickle cell disease, and in a Phase 2 study
to evaluate whether vepoloxamer improves the effectiveness of
recombinant tissue plasminogen activator therapy in patients with
acute limb ischemia. The Company also is planning to initiate
a Phase 2 study of vepoloxamer in patients with acute decompensated
heart failure in the first half of 2015. 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 the
Company's product candidates, including vepoloxamer in heart
failure, and anticipated timing of achievement of development
milestones, including commencement of a Phase 2 study of
vepoloxamer in 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 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; 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
planned clinical study of a product candidate; 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 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 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 vepoloxamer 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.