SAN DIEGO, Oct. 17, 2016 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) today announced that its
wholly-owned subsidiary, Aires Pharmaceuticals, Inc., has entered
into a collaborative agreement with Philips Respironics, Inc., the
sleep and respiratory care business of Royal Philips (NYSE: PHG, AEX: PHIA) related to
the supply of Philips' I-neb® Adaptive Aersol Delivery (AAD™) devices and related
consumables for the nebulized delivery of the Company's lead
product candidate, AIR001, a sodium nitrite solution for
intermittent inhalation. The I-neb® handheld AAD™ system is a small, portable and virtually
silent vibrating mesh technology nebulizer system designed to
deliver more precise, reproducible doses of medication faster than
conventional jet or ultrasonic nebulizers.
"As we announced last month, we are accelerating activities
related to our AIR001 program with support for ongoing,
investigator-sponsored Phase 2 clinical studies of AIR001 being
conducted at three separate prestigious research institutions,"
said Brian M. Culley, Chief
Executive Officer of Mast. "As part of this commitment, we are
pleased to be working with Philips, a recognized global leader in
the development of aerosol delivery devices and a leading provider
of innovative solutions for the global respiratory market. Our
agreement has been extended to include not only two of the Phase 2
studies of AIR001 currently underway, but also future clinical
studies and will remain in place until 2020 or sooner, if replaced
with a commercial supply agreement."
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. In
a randomized, double-blind, placebo-controlled Phase 2a study of
AIR001 in patients with HFpEF (n=26), the AIR001 treatment group
showed a statistically significant decrease in pulmonary capillary
wedge pressure during exercise compared to the control group and
AIR001 was generally well-tolerated.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical
company headquartered in San Diego,
California. The Company has two clinical-stage
investigational new drugs, AIR001 and vepoloxamer. AIR001, a
sodium nitrite solution for intermittent inhalation via nebulizer,
is in Phase 2 clinical development for the treatment of heart
failure with preserved ejection fraction (HFpEF). More
information can be found on the Company's web site at
www.masttherapeutics.com. Mast Therapeutics™ and the
corporate logo are trademarks of Mast Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements in this press
release that are not a description of historical fact are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements may be identified by the use of words referencing future
events or circumstances such as "expect," "intend," "plan,"
"anticipate," "believe," and "will," among others. Examples
of forward-looking statements in this press release include
statements relating to the Company's development plans for
AIR001. Forward-looking statements should not be read as
guarantees of future performance or results because they involve
the Company's beliefs and assumptions based on currently available
information and are subject to significant known and unknown risks
and uncertainties that may cause actual performance and results to
differ materially from expectations indicated by the
forward-looking statements. Some of the factors that could cause
actual performance or results to differ include, without
limitation: the Company's need for additional funding to continue
to operate as a going concern; risks associated with the Company's
ability to manage operating expenses and obtain additional capital
as needed; uncertainty related to the Company's ability to remain
in compliance with the terms and conditions under its debt facility
and risk that the Company may be required to repay its remaining
outstanding debt obligation on an accelerated basis and/or at a
time that could be detrimental to the Company's financial
condition, operations and/or business strategy; the impact of
significant reductions in the Company's operations on its ability
to develop its product candidates or maintain compliance with laws
and regulations relating to public companies; the Company's ability
to maintain compliance with NYSE MKT continued listing standards
and policies and to maintain the listing and trading of its common
stock on that exchange; uncertainties inherent in the conduct of
clinical studies and the risk that the Company's product candidates
may not demonstrate adequate safety, efficacy or tolerability in
one or more clinical studies for approval by regulatory
authorities; the potential for the Company to sell or license part
or all of its assets; the potential for significant delays,
reductions, or discontinuation of current and/or planned
development activities if the Company is unable to raise sufficient
additional capital as needed; the Company's lack of control over
investigator-sponsored clinical studies of AIR001, including
whether any of the studies will commence or be completed on
anticipated timelines, or at all; the Company's dependence on third
parties to assist with important aspects of development of the
Company's product candidates, including the conduct of clinical and
nonclinical studies, the manufacture and supply of clinical trial
material and drug delivery devices, and the conduct of regulatory
activities, and the risk that such third parties may fail to
perform as expected leading to delays in product candidate
development and additional costs; the risk that the Company is not
able to obtain or maintain effective patent coverage or other
market exclusivity protections for its products, if approved, or
that the use or manufacture of the Company's products may infringe
the proprietary rights of others; and other risks and uncertainties
more fully described in the Company's press releases and its
reports filed 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.