SAN DIEGO, April 4, 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 data from nonclinical studies of
vepoloxamer, its lead product candidate, were presented at the
American College of Cardiology (ACC) 65th Annual
Scientific Sessions & Expo. The results were presented by
Dr. Hani N. Sabbah, Professor of Medicine and Director of
Cardiovascular Research at Henry Ford Health System, at
9:45 a.m. ET on April 3, 2016 and 9:45
a.m. on April 4, 2016. The ACC
conference is being held at the McCormick Place Convention Center
in Chicago, IL, April 2 through April 4, 2016.
The studies evaluated the effects vepoloxamer on ventricular
function and calcium cycling proteins in dogs with severe heart
failure. Animals were randomized to receive vepoloxamer or placebo
(saline) and each received two infusions of vepoloxamer or saline
control administered three weeks apart. Tissue samples obtained
three weeks after the second infusion were assessed for
Ca2+-ATPase activity, phosphorylated (p) phospholamban
at serine-16 (p-PLB-s16), p-ryanodine receptors at serine-2808
(p-RYR-s2808) and p-sodium-calcium-exchanger 1 (p-NCX-1) measured
using specific antibodies and Western blotting. LV tissue
from seven normal animals was utilized for comparison. LV function
was assessed by full hemodynamics, plasma n-terminal-pro brain
natriuretic peptide (NT-proBNP) and plasma- troponin-I (Tn-I) at
baseline and at 1, 2 and 3 weeks following each infusion.
With regard to calcium cycling proteins, saline infusions had no
effect on any of the examined functional measures. However,
treatment with vepoloxamer partially normalized activity and
protein levels. The results suggest that by limiting unregulated
calcium entry into the cell, vepoloxamer decreased calcium overload
in failing cardiomyocytes and improved calcium cycling proteins,
leading to improved LV function.
With regard to ventricular function, vepoloxamer increased LV
ejection fraction and progressively reduced NT-proBNP and Tn-I as
previously reported. These benefits were sustained for up to 3
weeks after the second infusion of vepoloxamer. The results suggest
that therapy with repeat intravenous 2-hour infusions of
vepoloxamer, pulsed at 3-week intervals, improves LV systolic
function, lowers NT-proBNP and reduces Tn-I, a measure of ongoing
cardiomyocyte death.
Dr. Sabbah said: "These additional findings related to the
normalization of key calcium cycling proteins are consistent with
the observed improvements in ventricular function. While
additional studies are needed to verify these observations, the
results are very promising and suggest significant potential to
improve treatment for both acute and chronic heart failure
patients."
Dr. R. Martin Emanuele, the
Company's Senior Vice President, Development, said: "We believe the
activity of vepoloxamer is completely different from existing
therapies and may offer a new approach to treating heart failure by
directly improving heart function. In addition, because of
its unique mechanism, vepoloxamer could be additive to existing
therapies. We look forward to further demonstrating vepoloxamer's
potential in our Phase 2 clinical trial in chronic heart failure
patients, which is currently underway."
Poster Information:
- The poster entitled "Vepoloxamer (Purified Poloxamer-188)
Restores Integrity of Cardiomyocyte Calcium Cycling Proteins in
Left Ventricular Myocardium of Dogs With Advanced Heart Failure"
was presented by Dr. Sabbah at 9:45 a.m.
ET on April 3, 2016, at the
McCormick Place Convention Center in Chicago, Illinois.
- The poster entitled "Multiple Intravenous Infusions of
Vepoloxamer (Purified Poloxamer -188) Elicit Progressive
Improvements in Plasma Biomarkers in Dogs with Advanced Heart
Failure" will be presented by Dr. Sabbah at 9:45 a.m. ET today, April
4, 2016, at the McCormick Place Convention Center in
Chicago, Illinois.
- Copies of the posters will be available after 9:45 a.m. ET on the Company's website at:
http://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 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 in February 2016. 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 a Phase 2a study of AIR001
in patients with HFpEF is ongoing and AIR001 was recently selected
by the Heart Failure Clinical Research Network for evaluation in a
100-patient, multicenter, randomized, double-blind,
placebo-controlled, Phase 2 study 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 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 "intend," "plan," "anticipate,"
"believe," "expect," among others, and include, but are not limited
to, statements relating to prospects for successful development of
vepoloxamer as a treatment for heart failure patients. 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 in the ongoing Phase 2 study of vepoloxamer in
patients with chronic heart failure; 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; delays in clinical
study closeouts, including blinded data review and quality control
and assurance procedures; the risk that, even if current and
planned 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 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 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 if results from the EPIC study are not positive;
risks associated with the Company's ability to manage operating
expenses and/or obtain additional funding to support its operations
on a timely basis or on acceptable terms, or at all; 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 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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SOURCE Mast Therapeutics, Inc.