SAN DIEGO, Sept. 6, 2016 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company
developing novel, clinical-stage therapies for sickle cell disease
and heart failure, today announced that it is joining other
industry leaders, patient advocacy groups, researchers, clinicians,
policymakers, and foundations in a collective effort to improve
sickle cell disease (SCD) care, early diagnosis, treatment, and
research both in the United States
and globally. The newly formed Sickle Cell Disease Coalition is
spearheaded by the American Society of Hematology (ASH) and aspires
to change the status quo of SCD treatment and awareness.
SCD is an inherited, lifelong disorder characterized by red
blood cells that become rigid and sickle-shaped, which causes them
to stick together and block the flow of oxygen to the body, leading
to intense pain and other serious issues such as stroke, organ
failure, and death. SCD affects approximately 100,000 Americans and
millions worldwide. It is a growing health problem and it is
estimated that by 2050 the number of people with SCD will increase
by 30 percent globally. Over the last century, several
important discoveries have led to improved diagnosis and
treatments, but people with the disease still have severe
complications and shorter life expectancy. Many are unable to
access the care they need and live with pain and disability due to
a lack of effective treatment options.
Today, at a press conference and formal launch of the Coalition
at the Knight Conference Center of the Newseum in Washington, D.C., the Coalition will announce
a call to action on SCD and the American Society of Hematology and
several members of the Coalition will issue a new report, State
of Sickle Cell Disease: 2016, which outlines unmet needs
in four priority areas: Access to care, training and professional
education, research and clinical trials, and global health. The
report shows that significant improvements are needed across all
areas and highlights strategies for change.
"Around the world, people with sickle cell disease face unique
challenges – from early death and childhood stroke in countries
without early screening programs to lifetimes of mental and
physical disability due to lack of access to appropriate care in
the United States. We can no
longer accept that this is the status quo," said Charles S. Abrams, M.D., President of the
American Society of Hematology, the organization spearheading the
Coalition. "The Sickle Cell Disease Coalition is bringing together
a number of groups that care about this disease to take advantage
of the opportunities we have for change."
"We are proud to join ASH and other organizations to support the
Coalition's ultimate objective of improving outcomes for
individuals with sickle cell disease," stated Brian M. Culley, Chief Executive Officer of Mast
Therapeutics. "At Mast, we are working to improve outcomes for
sickle cell patients through the development of our investigational
new drug vepoloxamer. We are hopeful Mast will be able to
provide the first approved medication for intervention in
vaso-occlusive crisis, a debilitating and recurrent condition for
sickle cell patients that can lead to organ damage and early
death," continued Mr. Culley. "We believe that the Coalition will
be able to increase awareness of this devastating disease and
create more opportunity for changes that can improve care and
treatment of individuals living with sickle cell disease."
The Coalition will provide a platform to encourage stakeholders
to work together to develop and implement important projects and
activities that will ultimately help the SCD community and improve
outcomes for individuals with the disease. For more information on
the Coalition and its mission, visit www.scdcoalition.org.
About the Sickle Cell Disease Coalition
The mission
of the Sickle Cell Disease Coalition (SCDC) (www.scdcoalition.org)
is to help amplify the voice of the SCD community, promote
awareness, and improve outcomes for individuals with SCD. The
Coalition is focused on promoting research, clinical care,
education, training, and advocacy as well as providing a platform
to encourage stakeholders to work together to develop and implement
important projects and activities that will ultimately help the SCD
community and improve outcomes for individuals with the disease.
The Coalition is comprised of leading patient advocacy groups,
people with SCD and their families, researchers, clinicians,
policymakers, industry, and foundations with an interest in
SCD.
About Mast Therapeutics
Mast Therapeutics, Inc. is a
publicly traded biopharmaceutical company headquartered in
San Diego, California. The Company
is developing two clinical-stage investigational new drugs for
serious or life-threatening diseases and conditions. Vepoloxamer,
the Company's lead product candidate, is in Phase 3 clinical
development for the treatment of vaso-occlusive crisis in patients
with sickle cell disease and in Phase 2 clinical development for
the treatment of patients with heart failure. Enrollment in
the Company's 388-patient Phase 3 study of vepoloxamer in patients
with sickle cell disease, known as the EPIC study, was completed
earlier this year. Enrollment in the Company's Phase 2 study
of vepoloxamer in patients with chronic heart failure is
ongoing. AIR001, the Company's second product candidate, is
in Phase 2 clinical development for the treatment of patients with
heart failure with preserved ejection fraction (HFpEF). Enrollment
in Phase 2 studies of AIR001 in patients with HFpEF are ongoing,
including a 100-patient, multicenter, randomized, double-blind,
placebo-controlled, Phase 2 study in patients with HFpEF being
conducted by the Heart Failure Clinical Research Network.
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
within the meaning of the Private Securities Litigation Reform Act
of 1995 that are based on the Company's current expectations and
assumptions. Such forward-looking statements may be identified by
the use of forward-looking words such as "expect," "intend,"
"plan," "anticipate," "believe," among others, and include, but are
not limited to, statements relating to prospects for successful
development and commercialization of the Company's product
candidates, including vepoloxamer for the treatment of
vaso-occlusive crisis of sickle cell disease. There are a
number of factors that could cause or contribute to material
differences between actual events or results and the expectations
indicated by the forward-looking statements. These factors include,
but are not limited to: the inherent uncertainty of outcomes
in ongoing and future studies of the Company's product candidates
and the risk that its product candidates may not demonstrate
adequate safety, efficacy or tolerability in one or more such
studies, including vepoloxamer in the Phase 3 "EPIC" study, and may
not receive FDA or other regulatory authority approval; risks
associated with the Company's ability to manage operating expenses
and obtain additional capital as needed; the Company's potential
inability to continue as a going concern if it does not raise
sufficient additional capital as needed; 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, including
the prepayment of $10 million of the
principal balance of its debt facility if results from the EPIC
study are not positive and/or not available on or before
October 14, 2016; the potential for
the Company to significantly delay, reduce or discontinue current
and/or planned development and commercial-readiness activities or
sell or license its assets at inopportune times if it is unable to
raise sufficient additional capital as needed; the risk that, even
if EPIC study results are positive, the FDA may require a second
Phase 3 study or other clinical or nonclinical studies to
demonstrate substantial evidence of vepoloxamer's effectiveness for
sickle cell patients or to provide additional safety and
tolerability data or that the FDA may require changes to
manufacturing controls or processes that could delay filing of a
new drug application; 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 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 dependence on third parties to assist with important
aspects of development of its product candidates, including conduct
of its clinical studies and supply and manufacture of clinical
trial material, and, if approved, commercial product, and the risk
that such third parties may fail to perform as expected, leading to
delays in product candidate development or approval or inability to
meet market demand for approved products, if any; 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 obtain and maintain effective patent coverage or other
market exclusivity protections for its products, if approved,
without infringing 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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