Phase I clinical study in cancer patients
with solid tumors anticipated to begin Q4 2013
Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage
biopharmaceutical company developing potential best-in-class
oncology therapies, today announced the on-line publication of
preclinical results for RX-3117 in a peer reviewed medical journal,
Investigational New Drugs, in an article titled, “Metabolism,
mechanism of action and sensitivity profile of
fluorocyclopentenylcytosine (RX-3117; TV-1360)”. Investigational
New Drugs is an interdisciplinary journal presenting the latest
investigations and discussions of critical questions appropriate to
the entire field of new anticancer drug development.
Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer,
commented, “The broad spectrum of anti-tumor activity against human
cancer cell lines, oral bioavailability in cancer patients, and
improved preclinical and clinical safety profile suggest that
RX-3117 may represent a major advance in the treatment of solid
cancer tumors. Rexahn anticipates initiating a Phase I clinical
study in cancer patients with solid tumors in the fourth quarter of
2013.”
The published study characterized the broad spectrum of potent
anti-tumor effects of RX-3117 against 50 different human cancer
cell lines (including colon, lung, renal and pancreas) and its
unique mechanism of activation in cancer cells. In addition,
RX-3117 was shown to be effective in gemcitabine resistant human
cancer cell lines. Although RX-3117 shares some properties with
other nucleoside compounds such as gemcitabine, its cytotoxicity
profile, metabolism and mechanism of action make it distinct and
potentially clinically superior to existing nucleoside
compounds.
Prof. Dr. Godefridus J. (Frits) Peters, Head Laboratory Medical
Oncology, VU University Medical Center, Amsterdam, The Netherlands,
and lead author of the published results, commented, “RX-3117 is an
exciting new nucleoside analog with unique properties both
regarding its mechanism of action and its pharmacology. Its
excellent oral bioavailability fits very well with the current
tendency to give anticancer drugs orally. Its mechanism of action
gives several leads for future combination therapies with different
drugs.”
About RX-3117
RX-3117 is a novel small molecule nucleoside compound that is
incorporated into DNA or RNA of cancer cells and inhibits both DNA
and RNA synthesis which induces apoptotic cell death of tumor
cells. RX-3117 also mediates the down-regulation 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.
RX-3117 has demonstrated a broad spectrum anti-tumor activity
against 50 different human cancer cell lines and efficacy in 12
different mouse xenograft models. The efficacy in the mouse
xenograft models was superior to that of gemcitabine. In addition,
in human cancer cell lines made resistant to the anti-tumor effects
of gemcitabine, RX-3117 still retains its full anti-tumor
activity.
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 34-58% 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.
The Investigational New Drug (IND) application for RX-3117 filed
in July 2013 has now cleared the 30 day review period by the US
Food and Drug Administration (FDA). Rexahn expects to initiate a
Phase I clinical trial in cancer patients during the fourth quarter
of 2013. Additionally, Rexahn will be exploring potential
partnering opportunities with oncology focused pharmaceutical
companies.
About Prof. Dr. Godefridus J. (Frits) Peters
Dr. Peters is head of the Laboratory Medical Oncology of the VU
University Medical Center in Amsterdam (the Netherlands). The
research of Prof. Peters is focused on translation of preclinical
pharmacology of anticancer agents to the clinic. Dr. Peters has
published more than 500 peer reviewed articles, review chapters and
abstracts in high profile scientific journals. Drug classes studied
include antifolates, other antimetabolites, platinum analogs,
topoisomerase inhibitors, taxanes and more recently anti-signalling
protein kinase inhibitors. He is/was a member of 20 editorial
boards, was founder and first president of the Purine and
Pyrimidine Society, and is chair of the EORTC-Pharmacology and
Molecular Mechanisms Group.
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.
The Trout Group LLCTricia Truehart,
646-378-2953ttruehart@troutgroup.com
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