SAN DIEGO, Feb. 4, 2015 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today reported the initiation
of patient dosing in two institutional-sponsored Phase 2a studies
of AIR001 for the treatment of patients experiencing heart failure
with preserved ejection fraction (HFpEF). The Phase 2a
studies, currently underway at Mayo Clinic and the University of Pittsburgh, are evaluating the
hemodynamic effects of AIR001 in both acute and exercise
conditions, as well as change in submaximal oxygen consumption
before and after AIR001 versus placebo. A third clinical study
designed to compare the hemodynamic benefits versus the formation
of methemoglobin comparing intravenous nitrite to AIR001 is
expected to begin later this year.
Brian M. Culley, Chief Executive
Officer, stated: "We are pleased to report that patient
dosing recently began in these Phase 2a studies of AIR001. Last
year, we reported positive top-line results from a Phase 2 study of
AIR001 which demonstrated improvements in hemodynamic parameters
and exercise capacity and showed that AIR001 was well-tolerated,
with no treatment-related serious adverse events. That data showed
benefits consistent with prior studies of AIR001, supporting our
plans for continued development. We believe the hemodynamic
benefits of AIR001 are particularly suited to a HFpEF population
with elevated pulmonary artery and pulmonary capillary wedge
pressures, for which no FDA-approved therapies are currently
available. We anticipate reporting preliminary data from these
Phase 2a studies beginning the second half of this year."
About AIR001
AIR001 is a sodium nitrite solution for intermittent inhalation
via nebulizer. Nitrite is a physiological signaling molecule with
roles in intravascular endocrine nitric oxide (NO) production,
hypoxic vasodilation signaling, and cytoprotection after
ischemia-reperfusion. Nitrite serves as the largest physiologic
reservoir of NO and can be converted to NO independent of nitric
oxide synthase (NOS) activity. In experimental models, nitrite use
has demonstrated improved remodeling both in the pulmonary
vasculature and right ventricle. Hemodynamic effects include
venodilation with reductions in right atrial pressures, pulmonary
and systemic vasodilation with reductions in pulmonary vascular
resistance and left atrial pressures, and improved cardiac
relaxation. Mast Therapeutics obtained the AIR001 program through
its acquisition of privately-held Aires Pharmaceuticals, Inc. in
2014.
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 second quarter 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 anticipated
milestones for the Company's development programs, including AIR001
in HFpEF. 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
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; 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 as
needed 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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