Potent efficacy in animal models with tumors
resistant to gemcitabine, a widely used chemotherapy drug
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN) a clinical stage
biopharmaceutical company developing best-in-class therapeutics for
the treatment of cancer, today announced additional data from
preclinical studies on the anti-tumor effects of RX-3117, a next
generation cancer cell specific nucleoside analog. In the study,
oral administration of RX-3117 inhibited tumor growth in 12
different human cancer xenograft models including colon, non-small
cell lung, small cell lung, pancreatic, renal, ovarian, and
cervical cancer. In addition, RX-3117 inhibited the growth of human
cancer cells lines shown to be resistant to the anti-cancer effects
of gemcitabine, including in the primary low-passage human
pancreatic tumorgraft model.
“Resistance to the anti-cancer effects of gemcitabine represents
a major clinical issue in the treatment of cancer patients. Up to
25% of cancer patients receiving one or more cycles of gemcitabine
rapidly become resistant to its anti-cancer activity. Based on
study results to date, both preclinical and clinical, we believe
RX-3117 holds the potential to be used for the treatment of tumors
that do not respond to gemcitabine and other chemotherapeutic
drugs,” commented Rexahn’s CEO, Peter D. Suzdak, Ph.D.
RX-3117 showed greater efficacy (tumor growth inhibition) as
compared to gemcitabine in four different xenograft animal models
with gemcitabine resistant human cancer cell lines: colorectal
cancer (Colo205), small cell lung cancer (H69), cervical cancer
(CaSki) and pancreatic cancer (CTG-0298).
Additionally, in a mouse xenograft model using human colorectal
cancer cells, those treated with RX-3117 showed significantly
longer survival as compared to those receiving other treatments.
Mice treated with RX-3117 showed 100% survival through day 95 after
initial treatment, compared to 13% of mice treated with
gemcitabine, and 25% of mice treated with irinotecan, both
FDA-approved drugs.
Results of these studies were presented in a poster titled, “A
novel small molecule cytidine analog, RX-3117, shows potent
efficacy in xenograft models, even in tumors that are resistant to
treatment with gemcitabine,” at the American Association for Cancer
Research (AACR) Annual Meeting 2014 on April 6, 2014.
Earlier this year, Rexahn initiated a Phase Ib trial for
RX-3117. The trial is a multi-center dose-escalation study which is
evaluating the safety, tolerability, dose-limiting toxicities and
maximal tolerated dose (MTD) of RX-3117 in patients with solid
tumors. Secondary endpoints include characterizing the
pharmacokinetic profile of RX-3117 and evaluating the preliminary
anti-tumor effects of RX-3117.
In August 2012, Rexahn reported the completion of an exploratory
Phase I clinical trial of RX-3117 in cancer patients conducted in
Europe, to investigate the oral bioavailability, safety and
tolerability of the compound. In this study, oral administration of
RX-3117 demonstrated an oral bioavailability of 56% and a plasma
half-life (T1/2) of 14 hours. In addition, RX-3117 was safe and
well tolerated in all subjects throughout the dose range
tested.
About RX-3117
RX-3117 is a next generation nucleoside analog that is activated
(phosphorylated) by the enzyme Uridine Cytidine Kinase (UCK) and
inhibits both DNA and RNA synthesis which induces apoptotic cell
death of tumor cells. UCK is overexpressed in multiple human
tumors, but has a limited presence in normal tissues. This unique
specificity for cancer cells may lead to an improved efficacy and
safety profile in cancer patients. RX-3117 also mediates the
downregulation of DNA methyltransferase 1 (DNMT1), an enzyme
responsible for the methylation of cytosine residues on newly
synthesized DNA and also a target for anticancer therapies.
Preclinical studies have shown RX-3117 to be effective in both
inhibiting the growth of various human cancer xenograft models,
including colon, lung, renal and pancreas, as well as overcoming
chemotherapeutic drug resistance.
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 SupinoxinTM (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.
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The Trout Group LLCTricia Truehart,
646-378-2953ttruehart@troutgroup.com
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