SAN DIEGO, March 11, 2014 /PRNewswire/ -- Mast
Therapeutics, Inc. (NYSE MKT: MSTX) announced today that the United
States Adopted Names (USAN) Council has selected "vepoloxamer" as
the unique non-proprietary (generic) name for the active
pharmaceutical ingredient (API) in MST-188, the Company's lead
product candidate. Mast sought a unique name for its API to
clearly identify it as different from non-purified
poloxamers. In support of its application, the Company argued
that drug products containing non-purified poloxamers should not be
substituted for MST-188 and that confusion between the two could
have serious toxicity consequences.
"In approving our application, we believe USAN recognizes that
the active ingredient in MST-188 is a new substance, with a
different safety profile to that found with non-purified material,"
said Brian M. Culley, the Company's
Chief Executive Officer. "The unique name associated with our
products will help safeguard patients from exposure to safety or
other risks resulting from substitution, as well as differentiate
our products in the marketplace, should any be approved."
Unlike discrete small molecules, polymers (including the active
ingredient in MST-188) are molecularly diverse; that is, polymers
contain chemical 'species' with varying structural
characteristics. The Company argued that, while the major
species in its purified API and the non-purified starting material
are the same, the refinement of polymer populations through the
Company's proprietary manufacturing process that meets the
Company's proprietary specifications (including the reduction of
specific populations associated with renal dysfunction), results in
a new substance with a different therapeutic index.
About the USAN Council
The USAN Council, tri-sponsored by the American Medical
Association, the United States Pharmacopeial Convention and the
American Pharmacists Association, serves the health professions in
the United States by selecting
simple, informative and unique nonproprietary names for drugs by
establishing logical nomenclature classifications based on
pharmacological and/or chemical relationships. In addition,
the U.S. Food and Drug Administration (FDA) cooperates with and is
represented on the USAN Council. The USAN Council aims for global
standardization and unification of drug nomenclature and related
rules to ensure that drug information is communicated accurately
and unambiguously.
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
MST-188, its lead product candidate, for serious or
life-threatening diseases with significant unmet needs.
MST-188 is a cytoprotective, hemorheologic, anti-inflammatory and
anti-thrombotic agent that has potential utility in diseases or
conditions characterized by microcirculatory insufficiency
(endothelial dysfunction and/or impaired blood flow).
The Company is enrolling subjects in EPIC, a pivotal phase 3
study of MST-188 in sickle cell disease. In early 2014, the
Company plans to initiate a phase 2, clinical proof of concept
study in acute limb ischemia that will evaluate whether MST-188
improves the effectiveness of existing thrombolytic agents.
The Company also is evaluating development options in heart
failure. 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 the
Company's ability to prevent or delay competitors from developing
and obtaining regulatory approval of drug products based on
versions of the API in MST-188, the prospects for a unique
non-proprietary name to help safeguard patients from risks related
to drug substitution or to provide a marketing advantage for the
Company, should MST-188 receive regulatory approval, and the
Company's development plans for MST-188 in heart failure and acute
limb ischemia, including the timing of initiation of any 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 MST-188
and the risk that MST-188 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 institutional review
boards or the FDA or other regulatory agencies to require
additional nonclinical or clinical studies prior to initiation of
any planned phase 2 clinical study of MST-188; the potential that,
even if clinical studies of MST-188 in one indication are
successful, clinical studies in another indication may not be
successful; 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 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
MST-188, including clinical studies, and regulatory activities for
MST-188, 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 MST-188
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 MST-188 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
MST-188 and prevent competitors from duplicating or developing
equivalent versions of its product candidates, including MST-188;
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.