Rexahn Announces Target Enrollment Reached in Phase 2a Clinical Trial of RX-3117 in Combination With ABRAXANE® in First-line...
March 04 2019 - 8:00AM
Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical-stage
biopharmaceutical company developing innovative therapies to
improve patient outcomes in cancers that are difficult to treat,
announced that is has completed enrollment in the Phase 2a clinical
trial of RX-3117 in combination with ABRAXANE (paclitaxel
protein-bound particles for injectable suspension) in first-line
metastatic pancreatic cancer patients.
This multicenter, single-arm, open-label study
is designed to evaluate the safety and efficacy of RX-3117 in
combination with ABRAXANE in first-line metastatic pancreatic
cancer patients. As of February 27, 2019, the target enrollment of
40 patients has been achieved. Patients were enrolled into the
study from 10 centers in the US. The primary endpoint is
progression free survival and study is expected to be completed in
the second half of 2019.
“We are on track to complete this study as
planned in the second half of this year,” said Ely Benaim,
M.D., chief medical officer of Rexahn. “Since many patients are
still being treated in the trial, it is too early to estimate
progression free survival, however we expect to report additional
safety and efficacy data later this year.”
In January, Rexahn presented preliminary data
from the study at the 2019 ASCO Gastrointestinal Cancers (ASCO GI)
Symposium. The poster can be viewed on the Company’s website at
https://www.rexahn.com/news-media/posters.
About RX-3117
RX-3117 is a novel, investigational, oral, small
molecule nucleoside compound. As observed in preclinical studies,
once intracellularly activated (phosphorylated) by uridine cytidine
kinase 2 (UCK2), it is incorporated into the DNA or RNA of cells
and inhibits both DNA and RNA synthesis, which induces apoptotic
death of tumor cells. Due to the high level of overexpression of
UCK2 in cancer cells, RX-3117 offers the potential for a targeted
anti-cancer therapy with an improved efficacy and safety profile.
RX-3117 is currently being studied in a Phase 2a clinical trial in
combination with ABRAXANE (paclitaxel protein-bound particles for
injectable suspension) in first line metastatic pancreatic cancer
patients and a Phase 2a clinical trial in patients with advanced or
metastatic bladder cancer. It has received Orphan Drug designation
for the treatment of pancreatic cancer. Additional information on
RX-3117 can be found on the Company’s website
at: https://rexahn.com/cms/portfolio/rx-3117/.
ABRAXANE® is a registered trademark of Celgene
Corporation.
About Rexahn Pharmaceuticals,
Inc.
Rexahn Pharmaceuticals Inc. (NYSE American: RNN)
is a clinical-stage biopharmaceutical company developing innovative
therapies to improve patient outcomes in cancers that are difficult
to treat. The Company’s mission is to improve the lives of cancer
patients by developing next-generation cancer therapies that are
designed to maximize efficacy while minimizing the toxicity and
side effects traditionally associated with cancer treatment.
Rexahn’s product candidates work by targeting and neutralizing
specific proteins believed to be involved in the complex biological
cascade that leads to cancer cell growth. Preclinical studies show
that several of Rexahn’s product candidates may be effective
against multiple types of cancer, including drug resistant cancers
and difficult-to-treat cancers, and others may augment the
effectiveness of current FDA-approved cancer treatments. The
Company has two oncology product candidates, RX-3117 and RX-5902,
in Phase 2 clinical development and additional compounds in
preclinical development, including RX-0301. For more information
about the Company and its oncology programs, 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 the ongoing Phase 2a clinical trial of
RX-3117 in combination with ABRAXANE, future operations and
products, the path of clinical trials and development activities,
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,
understandings and beliefs regarding the role of certain biological
mechanisms and processes in cancer; drug candidates being in early
stages of development, including clinical development; the ability
to initially develop drug candidates for orphan indications to
reduce the time-to-market and take advantage of certain incentives
provided by the U.S. Food and Drug Administration; the ability to
transition from our initial focus on developing drug candidates for
orphan indications to candidates for more highly prevalent
indications; and the expecting timing of results from our clinical
trials. 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.
Media Contact:DGI CommSusan Forman or Laura
Radocaj
+1-212-825-3210sforman@dgicomm.com lradocaj@dgicomm.com
Investor Contact:ir@rexahn.com
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