Rexahn Presents Data from Preclinical Studies of RX-21101
21 April 2014 - 11:00PM
Business Wire
- Proprietary nano-polymer conjugate of
docetaxel shows increased efficacy and reduced toxicity for this
widely used FDA-approved chemo drug
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:
- 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
- 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)
- RX-21101 inhibited the proliferation of
a variety of human cancer cells in the in vitro study
- The high water solubility of RX-21101
eliminates the need of toxic co-solvents that are used with
systemically administered docetaxel
- 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.
The Trout Group LLCTricia Truehart,
646-378-2953ttruehart@troutgroup.com
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