SAN DIEGO, May 26, 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, heart
failure, and arterial disease, today reported that it has initiated
an open-label, multicenter Phase 3 extension study of vepoloxamer
(MST-188) in sickle cell disease, referred to as "EPIC-E."
The study will enroll patients who have completed the
Company's Phase 3 EPIC study and are hospitalized for a subsequent
vaso-occlusive crisis.
"We continue to be excited about the potential for vepoloxamer,
which is years ahead of other investigational treatments for sickle
cell disease," stated Brian M.
Culley, Chief Executive Officer. "We have initiated EPIC-E
consistent with our prior guidance and plan to make this extension
study available at almost all of our more than 70 EPIC sites."
"We believe data from EPIC-E will enhance the quality of a New
Drug Application for vepoloxamer in this rare disease, as well as
contribute to enthusiasm for the EPIC study," stated Dr.
Edwin L. Parsley, Chief Medical
Officer. "In particular, for patients who may be hesitant to
participate in EPIC because they may be randomly assigned to
receive the placebo control, EPIC-E can provide the certainty of
receiving vepoloxamer for subsequent crises. EPIC-E also will
give study investigators experience administering vepoloxamer to
sickle cell patients in an unblinded manner, which we expect will
provide valuable feedback for us," continued Dr. Parsley.
About the EPIC-E Study
EPIC-E is an open-label,
multicenter Phase 3 extension study in sickle cell disease that
will assess the safety and tolerability of repeat administration of
vepoloxamer to sickle cell patients who have completed the EPIC
study and subsequently are hospitalized for a vaso-occlusive
crisis. Secondary objectives are to assess the rate of
re-hospitalization for recurrence of vaso-occlusive crisis and the
occurrence of acute chest syndrome, a severe and sometimes fatal
complication of sickle cell disease. The study is expected to
remain open for approximately one year.
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The
Company is leveraging its MAST 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 an investigational drug that, in addition to EPIC
and EPIC-E, is being tested in a Phase 2 study to evaluate whether
it improves the effectiveness of recombinant tissue plasminogen
activator therapy in patients with acute limb ischemia. The
Company also plans to initiate a Phase 2 study of vepoloxamer in
chronic heart failure in the third quarter of this year.
AIR001 is an investigational drug 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 and
commercialization of the Company's product candidates, including
vepoloxamer in sickle cell disease, heart failure and stroke, and
anticipated timing of achievement of development milestones,
including commencement and completion of clinical and nonclinical
studies. 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,
including EPIC; 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 or that the use or manufacture
of its products or product candidates infringe the proprietary
rights of others; 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