SAN DIEGO, Feb. 1, 2016 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company
developing novel, clinical-stage therapies for sickle cell disease
and heart failure, today reported that its product candidate
AIR001, a sodium nitrite solution being developed for treatment of
heart failure with preserved ejection fraction (HFpEF), has been
selected by the Heart Failure Clinical Research Network (HFN) for
evaluation in a 100-patient, multicenter, randomized, double-blind,
placebo-controlled, Phase 2 clinical trial known as the Inorganic
Nitrite Delivery to Improve Exercise Capacity in HFpEF
(INDIE-HFpEF) study.
The HFN is made up of premier clinical centers located across
North America and was established
to expedite clinical research on treatments and strategies to
improve the management of acute and chronic heart failure. The HFN
is providing the platform to conduct the INDIE-HFpEF study.
Mast Therapeutics will provide test materials, nebulizers,
and regulatory, technical, and additional financial support. The
Company expects to complete a contract with the HFN's Coordinating
Center, which will be the sponsor of the study, in the coming
weeks.
The collaborative scientific leadership for the study will
include Dr. Barry Borlaug, the
Principal Investigator, and the investigators from the HFN Regional
Coordinating Centers.
"Given the results from prior clinical studies of AIR001,
including decreases in right atrial and pulmonary capillary wedge
pressures, as well as improvements observed in pulmonary vascular
resistance and cardiac lusitrophy, AIR001 may further demonstrate
its potential benefit to patients with heart failure and preserved
ejection fraction in this study," stated Edwin L. Parsley, D.O., Chief Medical Officer of
Mast Therapeutics, Inc. "We have assisted with the study
development and will support training on AIR001 and nebulizer
devices, as well as assist in the submission of an institutional
Investigational New Drug application, which we anticipate will
occur in the first quarter of this year."
"We appreciate the HFN's recognition of the study of AIR001 in
heart failure as an appropriate area of investigation and the
opportunity to work with them," stated Brian M. Culley, Chief Executive Officer of Mast
Therapeutics, Inc. "With their help, we expect to accelerate
efforts to define the potential efficacy of AIR001 and hopefully
provide a viable and much-needed treatment option for patients who
have heart failure with preserved ejection fraction, as currently
there are no proven effective therapeutic agents available for this
large patient population."
About the Heart Failure Clinical Research Network
(HFN)
The primary goal of the HFN is to conduct multiple clinical
trials to evaluate treatments and strategies to improve management
of acute and chronic heart failure. The HFN provides a unique
platform for collaborative research by bringing together many
premier centers across North
America. HFN is composed of nine Regional Coordinating
Centers and their affiliated sites, whose investigators provide
scientific leadership in the collaborative development of the HFN's
scientific agenda. HFN is recognized for robust enrollment in heart
failure clinical trials and high scientific productivity. The goal
of partnering with HFN is to accelerate research and medical
innovation, and provide early results that may improve public
health. More information can be found on the HFN's website,
https://www.hfnetwork.org/.
About AIR001
AIR001 is a sodium nitrite solution for intermittent inhalation
via nebulization. Nitrite is a direct vasodilator and can be
recycled in vivo to form nitric oxide (NO) independent of
the classical NO synthase (NOS) pathway. Nitrite mediated NO
formation has several beneficial effects, including dilation of
blood vessels and reduction of inflammation and undesirable cell
growth. Generation of NO from sodium nitrite is not dependent upon
endothelial function and is enhanced in the setting of tissue
hypoxia and acidosis, conditions in which NOS activity typically is
depressed. In early clinical studies, AIR001 demonstrated positive
hemodynamic effects with reductions observed in right atrial
pressure and pulmonary capillary wedge pressure, as well as
improvements in mean pulmonary artery pressures, cardiac output,
and exercise tolerance as measured by six minute walk
distance. 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 its 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 (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 nebulization, for the treatment
of heart failure with preserved ejection fraction (HFpEF).
Vepoloxamer is an investigational new drug being evaluated 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 for the treatment of patients with chronic heart
failure. AIR001 is an investigational new drug being
evaluated in two institution-sponsored Phase 2a studies in patients
with HFpEF and recently was selected by the Heart Failure Clinical
Research Network for an approximately 100-patient,
placebo-controlled Phase 2 study 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 may
include, but are not limited to, statements relating to prospects
for successful development and commercialization of the Company's
investigational drugs, including AIR001, and anticipated timing of
achievement of development milestones, such as commencement of
clinical studies or progress with regulatory activities. 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: that the Company is not the
sponsor of the INDIE-HFpEF study and has no control over the
protocol for or conduct of the study, including whether the study
will commence or be completed on anticipated timelines, or at all;
the Company's reliance on third parties for the manufacture and
supply of test material and nebulizer devices for use in the
INDIE-HFpEF study and the risks the Company may not be able to
supply such material or devices for the study on a timely basis, or
at all, or may incur significant unanticipated expenses in
connection with procuring sufficient quantities; the uncertainty of
outcomes in ongoing and future studies of the Company's product
candidates and the risk that its product candidates, including
AIR001, may not demonstrate adequate safety, efficacy or
tolerability in one or more such studies, including INDIE-HFpEF;
the Company's ability to obtain and maintain effective patent
coverage and other market exclusivity protections for its products
without infringing on the proprietary rights of others; the risk
that the Company may be required to repay its outstanding debt
obligations on an accelerated basis and/or at a time that could be
detrimental to its financial condition, operations and/or business
strategy; the Company's ability to obtain additional funding on a
timely basis or on acceptable terms, or at all; the Company's
ability to complete development of and successfully commercialize
its product candidates and achieve profitability; 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.