SAN DIEGO, March 23, 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, arterial disease and heart failure, today
announced its plans to develop vepoloxamer (MST-188) for the
treatment of patients with chronic heart failure. Encouraged by
recently reported nonclinical results and input from experts in the
field, the Company expects to begin dosing in a Phase 2 study of
vepoloxamer in patients with chronic heart failure in the third
quarter of this year.
Wilson S. Colucci M.D., Professor
of Medicine and Physiology and Chief of Cardiovascular Medicine at
Boston University School of Medicine
said: "The results from studies in experimental heart failure are
encouraging and support clinical testing in patients with chronic
heart failure. If shown to translate to patients with
clinical heart failure, vepoloxamer may offer a way of directly
improving LV contractile function by restoring cardiomyocyte
membrane integrity and increasing their survival. Such a
novel mechanism offers great potential for our patients."
Brian M. Culley, Chief Executive
Officer of the Company, said: "While we are still in the planning
process, we expect the Phase 2 study will be a randomized,
double-blind, two-arm, placebo-controlled study of the safety and
efficacy of a single administration of vepoloxamer in patients with
chronic heart failure, including its effect on markers of cardiac
injury (troponin) and wall stress (NT-proBNP), as well as clinical
outcomes. We anticipate that the study will be conducted on
an outpatient basis and enroll approximately 150 patients at sites
in and outside of the U.S. Of note, we recently filed new
patent applications claiming the use of vepoloxamer in this and
other clinical settings of heart failure and will continue to
identify ways to create additional value and protect the sizeable
market opportunity of our vepoloxamer pipeline."
The Company previously reported results from two randomized,
placebo-controlled nonclinical studies of vepoloxamer in a model of
chronic, stable heart failure produced by intracoronary
microembolizations. In the first study, as reported last
year, 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. As the Company reported earlier this month, 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 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 individuals 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
Vepoloxamer is the unique
non-proprietary (generic) name for purified poloxamer 188.
The Company sought a unique name to clearly identify its purified
poloxamer 188 as different from non-purified poloxamers. In
support of its application for vepoloxamer to the United States
Adopted Names (USAN) Council, 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 drug products containing
vepoloxamer.
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 also
developing AIR001, a sodium nitrite solution for inhalation via
nebulizer, for the treatment of heart failure with preserved
ejection fraction (HFpEF).
Vepoloxamer is being tested in a pivotal Phase 3 study called
EPIC for the treatment of vaso-occlusive crisis in patients with
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 plans to initiate a Phase 2 study of
vepoloxamer in chronic heart failure in the third quarter of this
year. AIR001 is 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, anticipated
timing of commencement of a Phase 2 study of vepoloxamer in heart
failure, and the Company's ability to protect its intellectual
property rights, including through obtaining patents covering its
product candidates and their uses. 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 additional
nonclinical or clinical studies to be required prior to initiation
of a planned clinical study; 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 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; 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.