Company to initiate Phase IIa clinical trials in Q4 of 2013
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage
biopharmaceutical company developing best-in-class therapeutics for the
treatment of cancer, today announced that the European Patent Office has
granted the Company a patent, EP 1546180, for its clinical development
candidate Archexin® and its use for inhibiting the activated
form of Akt-1 (phospho-Akt1)for the treatment of cancer.
Having successfully completed a Phase IIa clinical trial of Archexin in
metastatic pancreatic cancer, Rexahn has conducted an extensive
scientific, clinical and business analysis of other potential
indications for additional Phase IIa clinical trials with the drug.
Rexahn is now working with key clinical opinion leaders to finalize the
design of a Phase IIa clinical trial in a selected tumor type and plans
on updating investors on the tumor type selection and Phase IIa trial
timeline in the fourth quarter of 2013.
Peter D. Suzdak, Ph.D., Rexahn's Chief Executive Officer commented, "The
issuance of this patent in Europe further strengthens our intellectual
property estate on Archexin and provides IP protection and an enhanced
position for Rexahn in a geography that represents a significant portion
of the global oncology treatment market. This comes at a very important
time for our Company, as we plan to embark on a new Phase IIa clinical
trial for Archexin in the fourth quarter of this year."
Archexin® is a unique anti-cancer drug candidate which
inhibits the cancer cell specific signaling protein phospho-Akt1.
Phospho-Akt1 is over expressed in human cancer cells as compared to
normal healthy tissue, and is involved in cancer cell growth, survival,
angiogenesis, and drug resistance. Phospho-Akt1 has been shown to be
present in most human cancer cell lines including in breast, colon,
kidney, liver, lung, ovarian, pancreatic, prostrate, and stomach cancer
cell lines. Archexin has been shown to inhibit the growth of human
cancer cell lines in tissue culture and well as increase survival in
various mouse cancer xenograft models.
Archexin has completed a Phase I clinical trial in cancer patients with
solid tumors and was shown to be safe and well tolerated. The
dose-limiting toxicity was a grade 3 fatigue. In a small Phase IIa trial
in advanced pancreatic cancer patients, Archexin in combination with
gemcitabine was shown to be safe and well tolerated and demonstrated a
preliminary efficacy signal with a median survival of 9.1 months in
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.
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.
For Rexahn Pharmaceuticals
The Trout Group LLC