PLx Pharma Inc. (NASDAQ:PLXP) (“PLx” or the “Company”), a specialty
pharmaceutical company, has been awarded a $1.9 million grant by
the National Cancer Institute (NCI) of the National Institutes of
Health (NIH) in support of PLx’s novel formulation of aspirin for
chemoprevention of colorectal cancer.
“This NCI grant will enable us to further advance research of
our novel formulation of aspirin for the prevention of colorectal
cancer, the fourth most commonly diagnosed cancer in the U.S.
today,” stated Natasha Giordano, President and Chief Executive
Officer of PLx.
The role of aspirin in platelet pharmacology is
well-established, and aspirin itself remains the foundational drug
used for cardiovascular disease prevention.
Dr. Lenard M. Lichtenberger, Professor of Integrative Biology
& Pharmacology at The University of Texas Health Science Center
at Houston (UTHealth), will be the Principal Investigator of
studies funded by this grant. The research will be conducted at
UTHealth, Baylor College of Medicine and The University of Texas MD
Anderson Cancer Center and will focus on further investigating this
novel formulation of aspirin’s role in colorectal cancer
prevention.
Further development of PLx’s novel phosphatidylcholine
(PC)-associated aspirin (Aspirin-PC) for the prevention of
colorectal cancer and potentially other cancers is supported by two
recently published studies in peer-reviewed journals of the
American Association for Cancer Research (AACR).
Cancer Prevention Research (February 2017) published a study by
Dr. Lichtenberger et al on the mechanism of Aspirin-PC in colon
cancer, both in cell culture and in a chemically-induced murine
model of colon cancer.1 This study demonstrated
Aspirin-PC’s activity with regard to antiplatelet effect and
chemoprevention in these preclinical models.
A December 2016 paper published in Molecular Cancer Therapeutics
described in vitro dose response studies comparing the
growth-inhibitory effect of Aspirin-PC versus regular aspirin on
three human and one murine ovarian cancer cell line over an 8-day
culture period and three independent mouse models of ovarian
cancer, two carrying different cell lines of human ovarian cancer
and one where a mouse ovarian cancer cell line was passaged.2 These
studies, conducted by Dr. Anil Sood and co-first authors Dr. Yan
Huang and Dr. Lichtenberger, et al, demonstrated Aspirin-PC’s
activity in inhibiting ovarian cancer growth under both in vitro
and in vivo conditions. Drs. Sood and Huang were with MD
Anderson Cancer Center, while Dr. Lichtenberger led a team at
UTHealth that included Drs. Elizabeth Dial and Dexing Fang.
The NCI grant, Award Number R42CA171408, will be disbursed in
two installments: $961,499 in 2017 and $966,160 in 2018.
1 Lichtenberger LM et al. Unlocking Aspirin's Chemopreventive
Activity: Role of Irreversibly Inhibiting Platelet
Cyclooxygenase-1. Cancer Prev Res; 10(2) February 2017.
2 Huang Y et al. Antitumor and Antiangiogenic Effects of
Aspirin-PC in Ovarian Cancer. Mol Cancer Ther; 15(12) December
2016.
About PLx Pharma Inc.
PLx Pharma Inc. is a specialty pharmaceutical
company focused on developing its clinically validated and
patent-protected PLxGuard™ delivery system to provide safe and
effective aspirin products. PLx Pharma’s lead product Aspertec™
Aspirin Capsules, 325 mg is FDA approved. PLx is focused on
completing manufacturing scale-up and label finalization for
Aspertec 325 mg aspirin dose strength and preparing an sNDA for
Aspertec 81 mg maintenance dose strength.
PLxGuard works by targeting delivery of active
pharmaceutical ingredients to various portions of the
gastrointestinal (GI) tract. PLx believes this delivery system has
the potential to improve the absorption of many drugs currently on
the market or in development, such as aspirin, and may provide
high-risk cardiovascular and stroke patients with more reliable and
predictable antiplatelet efficacy as compared to enteric coated
aspirin. PLx also believes PLxGuard has the potential to reduce
acute GI side effects—including erosions, ulcers and
bleeding—associated with aspirin and ibuprofen, and potentially
other drugs.
To learn more about PLx Pharma Inc. and its pipeline, please
visit www.plxpharma.com.
About the National Cancer Institute
(NCI)
NCI leads the National Cancer Program and the NIH’s efforts to
dramatically reduce the prevalence of cancer and improve the lives
of cancer patients and their families, through research into
prevention and cancer biology, the development of new
interventions, and the training and mentoring of new researchers.
For more information about cancer, please visit the NCI website
at cancer.gov or call NCI's Cancer Information Service at
1-800-4-CANCER.
About the National Institutes of Health
(NIH)
NIH, the nation's medical research agency, includes 27
Institutes and Centers and is a component of the U.S. Department of
Health and Human Services. NIH is the primary federal agency
conducting and supporting basic, clinical, and translational
medical research, and is investigating the causes, treatments, and
cures for both common and rare diseases. For more information about
NIH and its programs, visit nih.gov.
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 and risks that PLx may
lack the financial resources and access to capital to fund proposed
operations. Further information on the factors and risks that could
affect PLx’s business, financial conditions and results of
operations are contained in PLx’s filings with the U.S.
Securities and Exchange Commission (SEC), which are available
at www.sec.gov. Other risks and uncertainties are more fully
described in the Registration Statement on Form S-4 filed with
the SEC in connection with the merger of PLx and Dipexium
Pharmaceuticals, Inc., and in other filings that PLx will make
going forward. 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.
Contact
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Media:
Ann Smith, Coyne Public Relations
T: 973-588-2385
E: asmith@coynepr.com
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