Rexahn Pharmaceuticals, Inc. RNN, a clinical stage
biopharmaceutical company focused on developing first in class therapies for
the treatment of cancer, today provided an update on its strategic business
goals for 2013.
“I am pleased to report that Rexahn is positioned to achieve significant
strategic milestones in 2013. The infusion of $9 million from our recently
completed public offering and research funding from Teva Pharmaceuticals for
RX-3117 will enable the company to accelerate the clinical development of
Archexin, RX-3117, and RX-5902, while advancing three pre-clinical compounds
closer to clinical development,” said Peter D. Suzdak, Ph.D., CEO of Rexahn.
“Our anticipated clinical and pre-clinical development progress will both
increase shareholder value and support our strategic partnering efforts,”
added Dr. Suzdak.
Rexahn Goals for 2013:
* Identify and form strategic partnerships. Rexahn continues to explore
potential strategic partnerships to accelerate the development of its
oncology pipeline. Rexahn's pipeline of innovative oncology compounds
features six potential best-in-class compounds – three clinical stage
compounds (Archexin, RX-3117 (already partnered with Teva
Pharmaceuticals), and RX-5902) and three pre-clinical compounds (RX-21101,
RX-0047-N, and RX-0201-N). Each of these compounds offers an opportunity
for a partner to bolster its oncology portfolio with differentiated assets
possessing high potential clinical value.
* Continue RX-3117's clinical development with Teva Pharmaceuticals. RX-3117
is a proprietary small molecule compound that inhibits DNA
methyltransferase and DNA synthesis and is being co-developed with Teva
Pharmaceuticals for the treatment of cancer. In August 2012, Rexahn and
Teva concluded a first-in-human clinical study of RX-3117. In the clinical
study RX-3117 met its primary objective of determining the drug's oral
bioavailability in humans. The study supports RX-3117's position as a
potential future alternative to market leading anti-metabolite therapies
in the treatment of solid tumors in the colon, lung, bladder and pancreas.
As a result of this clinical study, Teva increased its ownership in Rexahn
to 6.3%. According to the Research and Exclusive License Option Agreement
and the Securities Purchase Agreement between Rexahn and Teva, the total
money received from Teva to date is $9.1 million. Rexahn expects to
receive additional milestone payments from Teva in the second half of 2013
with the submission of an IND and patient enrollment in a phase I clinical
trial.
* Initiate a Phase I clinical study with RX-5902. In 2013 Rexahn expects to
initiate a Phase I first-in-human clinical trial of RX-5902, an orally
available, first-in-class inhibitor of p68 RNA helicase for the treatment
of various solid tumors, such as melanoma and cancers of the ovary, kidney
and pancreas. Preclinical studies have demonstrated the inhibition of
tumor growth and enhanced survival in in vivo animal xenograft models,
synergistic action when combined with known anticancer agents, and potent
anti-growth activity in drug-resistant cancer cells.
* Initiate a Phase II clinical trial with Archexin. Archexin is a
proprietary first-in-class inhibitor of Akt protein kinase (Akt) which is
localized in cancer cells. Following the positive top-line phase IIa
clinical trial results for Archexin in pancreatic cancer reported in
August 2012, Rexahn plans to move forward with its Phase II clinical
program in 2013. Rexahn completed an open label study of Archexin in 2012
to determine the safety, tolerability and efficacy of the compound in
combination with gemcitabine. The study demonstrated that this combination
treatment provided a median survival of 9.1 months compared to the
historical survival data of 5.65 months for standard single agent
gemcitabine therapy.
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