Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage
biopharmaceutical company developing best-in-class therapeutics for the
treatment of cancer, today announced promising preclinical results for
RX-21101, the Company’s first development candidate derived from its
Nano-Polymer-Drug Conjugate System (NPDCS) platform. Results of the
study were presented in a poster titled, “Synthesis of targeted
docetaxel-polymer conjugate and its anti-tumor efficacy,” at the
American Association for Cancer Research (AACR) Annual Meeting 2014 held
earlier this month.
The preclinical study was conducted by Rexahn in collaboration with the
University of Maryland and Ohio State University, and evaluated the
effect of RX-21101 in both in vitro human cancer cell lines and in vivo
mice xenograft tumor models using human cancer cell lines. Results of
the preclinical studies were the following:
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RX-21101 showed complete tumor growth inhibition, enhanced tumor
regression, and extended survival in mouse xenograft models without
significant changes in body weight compared to intravenously
administered docetaxel
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The maximum tolerated dose of RX-21101 in mice was more than 150
mg/kg, which is much higher than that of free docetaxel (~25 mg/kg)
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RX-21101 inhibited the proliferation of a variety of human cancer
cells in the in vitro study
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The high water solubility of RX-21101 eliminates the need of toxic
co-solvents that are used with systemically administered docetaxel
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This study demonstrated that RX-21101 is a promising anti-tumor
development candidate with reduced toxicity and prolonged survival
“We are very encouraged by these preclinical findings, which showed that
RX-21101 can inhibit tumor growth, increase tumor regression, and
decrease the toxicity normally associated with a chemotherapeutic drug.
Drug candidates developed on the NPDCS platform represent a clinical
development approach for Rexahn with low risk, as we work to improve
upon FDA approved anticancer compounds that are already widely used. We
believe that our NPDCS platform could offer opportunities to co-develop
and introduce new and improved versions of chemotherapeutic drugs that
currently are, or are soon to become generic,” commented Rexahn’s CEO,
Peter D. Suzdak, Ph.D.
Rexahn’s NPDCS platform combines existing chemotherapeutic agents with a
proprietary polymer carrier that contains a targeting moiety which
directs the drug directly into the tumor. This approach minimizes the
levels of freely circulating anti-cancer agents in the body, which can
reduce potential adverse events, and maximizes anti-tumor activities by
accumulating the drug in the cancer tumor. NPDCS is a broad platform
that has the potential to generate multiple development candidates for
Rexahn going forward.
RX-21101 is a polymer conjugated form of docetaxel, a common
chemotherapy agent that is now generic but is marketed worldwide under
the trade name Taxotere® and had annual sales of $3.1 billion
when still under patent. Docetaxel is used in the treatment of breast,
ovarian, prostate, and non-small cell lung cancer.
About RX-21101
RX-21101 was developed using the Nano-Polymer-Drug Conjugate Systems
(NPDCS) platform jointly discovered with the University of Maryland at
Baltimore. This technology targets the delivery of currently marketed
chemotherapeutic agents directly into cancerous tumors. The direct
delivery of chemotherapeutic drugs into the tumors has been shown to
result in increased efficacy and reduced toxicity. The NPDCS platform
combines existing chemotherapeutic agents with a proprietary polymer
carrier that contains a signaling moiety which directs the drug into the
tumor. This approach minimizes the levels of freely circulating
anti-cancer agents in the body, which can dramatically reduce potential
adverse events, and maximizes anti-tumor activity by accumulating the
anticancer agent in the cancer tumor. NPDCS is a broad platform that has
the potential to generate multiple development candidates going forward.
Despite its commercial success, docetaxel is toxic to all dividing cells
in the body and is associated with a high incidence of adverse events
including anemia, infection, fever, neutropenia, neuropathy, asthenia,
edema, alopecia, nausea and vomiting. These adverse events are the
result of high concentrations of free docetaxel in the blood. By
minimizing the circulating concentration of free docetaxel in the blood
and maximizing the concentration in the cancer tumor, RX-21101 may
increase anti-tumor activity and have a lower incidence of adverse
events.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company
dedicated to developing best-in-class therapeutics for the treatment of
cancer. Rexahn currently has three clinical stage oncology candidates,
Archexin®, RX-3117, and Supinoxin™ (RX-5902) and a
robust pipeline of preclinical compounds to treat multiple types of
cancer. Rexahn has also developed proprietary drug discovery platform
technologies in the areas of Nano-Polymer-Drug Conjugate Systems
(NPDCS), nano-medicines, 3D-GOLD, and TIMES. For more information,
please visit www.rexahn.com.
Safe Harbor
To the extent any statements made in this press release deal with
information that is not historical, these are forward-looking statements
under the Private Securities Litigation Reform Act of 1995. Such
statements include, but are not limited to, statements about Rexahn’s
plans, objectives, expectations and intentions with respect to future
operations and products and other statements identified by words such as
“will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,”
“plans,” “expects,” “anticipates,” “estimates,” “may,” other words of
similar meaning or the use of future dates. Forward-looking statements
by their nature address matters that are, to different degrees,
uncertain. Uncertainties and risks may cause Rexahn’s actual results to
be materially different than those expressed in or implied by Rexahn’s
forward-looking statements. For Rexahn, particular uncertainties and
risks include, among others, the difficulty of developing pharmaceutical
products, obtaining regulatory and other approvals and achieving market
acceptance; the marketing success of Rexahn’s licensees or sublicensees;
the success of clinical testing; and Rexahn’s need for and ability to
obtain additional financing. More detailed information on these and
additional factors that could affect Rexahn’s actual results are
described in Rexahn’s filings with the Securities and Exchange
Commission, including its most recent annual report on Form 10-K and
subsequent quarterly reports on Form 10-Q. All forward-looking
statements in this news release speak only as of the date of this news
release. Rexahn undertakes no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Copyright Business Wire 2014