PLx Pharma Announces Publication of Positive Antiplatelet Data for Aspertec in Peer-Reviewed Medical Journal JACC
February 14 2017 - 7:30AM
PLx Pharma Inc. (PLx), a late-stage specialty pharmaceutical
company developing next-generation nonsteroidal anti-inflammatory
drugs and other pharmaceutical agents today announced that the
results of a 40-subject pharmacokinetic/pharmacodynamic (PK/PD)
trial of Aspertec™, a novel, patent-protected, lipid-based aspirin
product, have been published by the prestigious, peer-reviewed
Journal of the American College of Cardiology (JACC).
The publication, entitled “Enteric Coating and Aspirin
Nonresponsiveness in Patients with Type 2 Diabetes Mellitus,”
describes results of the study, which evaluated Aspertec 325 mg
versus two commercially-available 325 mg aspirin products: plain
(uncoated) and delayed-release, safety-coated (enteric-coated or
EC) aspirin, over 72 hours.
“This study contributes to the growing body of data on the
antiplatelet activity of different aspirin formulations within 72
hours of starting an aspirin regimen. The information gathered from
this PK/PD trial suggests that, for these patients, there was,
initially, substantial variability in antiplatelet activity
depending on the dose form of aspirin administered,” stated Deepak
L. Bhatt, MD, MPH, lead author of the study and Executive Director
of Interventional Cardiovascular Programs at Brigham and Women’s
Hospital and Professor of Medicine at the Harvard Medical
School.
“We are very encouraged by the published results of this study
and the potential of our novel lipid-based, liquid-filled Aspertec
capsule to provide reliable and predictable antiplatelet activity.
We believe Aspertec, with multiple potential benefits as a fast,
predictable and reliable antiplatelet agent, will provide an
important treatment option for prescribers in determining the
optimal aspirin formulation for use as the foundational medicine by
their secondary prevention and high-risk primary prevention
patients,” stated Natasha Giordano, President and Chief Executive
Officer of PLx.
The article is available online at
http://www.onlinejacc.org/content/early/2017/01/05/j.jacc.2016.11.050.
JACC publishes the highest quality articles highlighting all
aspects of cardiovascular health and disease. With a current impact
factor of 17.759, it is one of the most influential journals in the
field of cardiology.
About AspertecAspertec is an approved aspirin
product developed to provide reliable and predictable antiplatelet
activity. PLx is focused on completing manufacturing scale-up
and label finalization for Aspertec 325 mg aspirin dosage form and
preparing a supplemental new drug application (sNDA) for Aspertec
81 mg maintenance dose form.
About PLx PLx Pharma Inc. is a late-stage
specialty pharmaceutical company initially focused on developing
its clinically validated and patent-protected PLxGuard™ delivery
system to provide safe and effective aspirin products. The PLxGuard
delivery system works by targeting delivery of active
pharmaceutical ingredients (API) to various portions of the GI
tract. PLx believes this has the potential to improve the
absorption of many drugs currently on the market or in development,
and to reduce acute gastrointestinal (GI) side effects—including
erosions, ulcers and bleeding—associated with aspirin and
ibuprofen, and potentially other drugs.
On December 22, 2016, PLx announced that it had entered into a
merger agreement with Dipexium Pharmaceuticals, Inc. (NASDAQ:DPRX).
Following the closing of the merger—which is subject to a number of
conditions precedent, including approval of both PLx and Dipexium
stockholders—it is expected that Dipexium will be renamed “PLx
Pharma Inc.” and will operate under the leadership of the PLx
management team.
To learn more about PLx and its pipeline, please visit
www.plxpharma.com.
Forward-Looking Statements Any statements made
in this press release relating to future financial or business
performance, conditions, plans, prospects, trends, or strategies
and other financial and business matters, including without
limitation, the prospects for commercializing or selling any
products or drug candidates, are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. In addition, when or if used in this press release, the words
“may,” “could,” “should,” “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “plan,” “predict” and similar expressions and
their variants, as they relate to PLx may identify forward-looking
statements. PLx cautions that these forward-looking statements are
subject to numerous assumptions, risks, and uncertainties, which
change over time. Important factors that may cause actual results
to differ materially from the results discussed in the
forward-looking statements or historical experience include risks
and uncertainties, including the failure by PLx to secure and
maintain relationships with collaborators; risks relating to
clinical trials; risks relating to the commercialization, if any,
of PLx’s proposed product candidates (such as marketing,
regulatory, product liability, supply, competition, and other
risks); dependence on the efforts of third parties; dependence on
intellectual property; risks that PLx may lack the financial
resources and access to capital to fund proposed operations; and
risks that the proposed merger with Dipexium may not be
consummated. The forward-looking statements represent PLx’s
estimate as of the date hereof only, and PLx specifically disclaims
any duty or obligation to update forward-looking statements.
Citation for this article: Bhatt DL et al. Pharmacodynamic
Evaluation of PL2200 Versus Enteric-Coated and Immediate Release
Aspirin in Diabetic Patients. Journal of the American College of
Cardiology Jan 2017, 23269; DOI: 10.1016/j.jacc.2016.11.050
Source: PLx Pharma Inc.
Contact Information
Natasha Giordano
PLx Pharma Inc.
ngiordano@plxpharma.com
713-842-1249
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