SAN DIEGO, Jan. 5, 2015 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage
biopharmaceutical company, today reported that enrollment in its
pivotal EPIC study of its lead product candidate vepoloxamer
(MST-188) in sickle cell disease surpassed the one-third enrollment
milestone, ahead of internal projections. The Company remains
on-track to complete enrollment by the end of 2015 and, consistent
with prior guidance, anticipates reporting top line results in the
first quarter of 2016.
"We are extremely pleased to report that, as of today, 130
patients have been randomized to the EPIC study, which is ahead of
the enrollment projections we set for ourselves more than a year
ago," stated Brian M. Culley, Chief
Executive Officer. "We now have opened almost 70 sites in ten
countries, with more than 50 of those sites located in the U.S. I
am pleased to affirm that we remain on-track to complete enrollment
this year, which means we expect to announce top line data in the
first quarter of 2016. As there has never been a drug approved for
sickle cell patients to treat an ongoing crisis, we are both
hopeful and excited for a positive outcome from the EPIC
study."
"We have built a sense of camaraderie with the sickle cell
medical community and are enjoying a groundswell of momentum that
is helping to drive enrollment," added Edwin L. Parsley, D.O., Chief Medical Officer.
"Of note, approximately 60% of the sites we have opened in
EPIC have enrolled at least one subject and two-thirds of those
sites have enrolled two or more subjects. This broad activity
indicates that investigators worldwide are excited about the study
and are encouraging their patients to participate."
"I am also pleased to highlight that the EPIC study's
independent Data and Safety Monitoring Board ("DSMB") has held
multiple pre-planned meetings and recommended that the study
proceed without any changes," added Dr. Parsley.
Additional milestones anticipated from the Company in 2015
include:
- Reporting data from a repeat-dose nonclinical study of
vepoloxamer in heart failure;
- Initiating a Phase 2 clinical study of vepoloxamer in acute
decompensated heart failure;
- Initiating enrollment in an open-label EPIC extension study,
referred to as EPIC-E, to expand the Company's existing safety
database regarding repeat exposure to vepoloxamer;
- Reporting data from a nonclinical study of vepoloxamer in
embolic stroke; and
- Reporting data from one or more of the Phase 2a studies of
AIR001 in patients suffering heart failure with preserved ejection
fraction (HFpEF).
Conference Call Information
Interested parties may access the conference call on
Tuesday, January 6, 2015 by dialing
(877) 870-4263 from the U.S. and (412) 317-0790 from outside the
U.S. and should request the Mast Therapeutics, Inc. Corporate
Update Call. The webcast will be available live via the Internet by
accessing the Investors section of Mast's website at
http://www.masttherapeutics.com/investors/events/. Replays of the
webcast will be available on the Company's website for 30 days and
a phone replay will be available through January 15, 2015 by dialing (877) 344-7529 from
the U.S. and (412) 317-0088 from outside the U.S. and entering
conference reference number 10057420.
About Vepoloxamer
In March 2014, the Company
announced that the United States Adopted Names (USAN) Council
assigned "vepoloxamer" as the unique non-proprietary (generic) name
for the active pharmaceutical ingredient (API) in MST-188. The
Company sought a unique name for its API to clearly identify it as
different from non-purified poloxamers. In support of its
application, 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 MST-188.
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 first half 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 regarding the EPIC
study, including timing of completion of patient enrollment and
announcement of data, and relating to anticipated milestones for
the Company's other development programs. 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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SOURCE Mast Therapeutics, Inc.