SAN DIEGO, April 9, 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
announced that its lead compound (vepoloxamer) was shown in a
nonclinical study to result in dose-dependent and statistically
significant reductions in the adhesive properties and fragility of
red blood cells from patients with sickle cell disease. The results
were obtained from a microfluidics-based assessment of blood
samples from 12 sickle cell patients. Data from this study
will be presented at the 9th Annual Sickle Cell Disease
Research & Educational Symposium and 38th National
Sickle Cell Disease Scientific Meeting taking place April 10-13, 2015 at the Westin Diplomat in
Hollywood,
Florida.
Dr. R. Martin Emanuele, Senior
Vice President, Development, said: "These results are encouraging
since hemolysis and adhesiveness of sickle red blood cells are
thought to be causal pathologies underlying vaso-occlusive
crisis. Of note, we observed a strong concentration-related
response for both parameters, which supports the veracity of the
drug effect. Also, with regard to the inhibition of cell
adhesion, the maximal response in this study was observed over the
range of blood concentrations we are targeting in our ongoing Phase
3 study. As such, this data is supportive of effects we expect to
see in our Phase 3 EPIC study."
Additionally, the Company's CEO, Brian
M. Culley, will participate with a presentation entitled,
"Epic Considerations for the EPIC Clinical Trial," in the
Investigational Drug Symposium, taking place on Sunday, April 12, 2015, chaired by Susan Perrine, M.D., Professor of Medicine,
Pediatrics and Pharmacology and Experimental Therapeutics at
Boston University School of
Medicine.
The Company also will participate in the Symposium's Technology
Session entitled, "Striving for a Unified mHealth Strategy for
Research and Clinical Care in Sickle Cell Disease," with a
presentation by Gregory D. Gorgas, Senior Vice President,
Commercialization, that will feature the free mobile app VOICE
Crisis Alert™, which was developed by the Company for
individuals with sickle cell disease to track and communicate their
crises with their healthcare providers and caregivers.
Abstract Information:
- An abstract entitled, "Evaluation of purified poloxamer-188
(vepoloxamer) on sickle red blood cell (RBC) adhesion and membrane
fragility utilizing microfluidic-based flow adhesion bioassays," by
Patrick C. Hines M.D., Ph.D.,
Jennell White, Ph.D., Xiufeng Gao, M.D., and Ke Liu, Ph.D. of Functional Fluidics and
R. Martin Emanuele, Ph.D. of Mast
Therapeutics, Inc. summarizes the study data to be presented.
- The abstract is available on the Company's website at
www.masttherapeutics.com/technology/publications/.
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 being tested 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 to evaluate whether
vepoloxamer improves the effectiveness of recombinant tissue
plasminogen activator therapy in patients with acute limb ischemia.
The Company plans to initiate a Phase 2 study of vepoloxamer in
chronic heart failure in the third quarter of this year. AIR001 is
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 of
vepoloxamer in sickle cell disease, including success with the EPIC
study, and anticipated timing of commencement of other clinical
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; 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.