New Data Show Rexahn's Supinoxin(TM) Decreases the Migration of Human Triple Negative Breast Cancer Cells in a Metastatic Can...
21 April 2015 - 11:00PM
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage
biopharmaceutical company developing best-in-class therapeutics for
the treatment of cancer, today announced that it presented
preclinical data on Supinoxin™ (RX-5902) at the 2015 American
Association for Cancer Research (AACR) Annual Meeting in
Philadelphia. This presentation entitled, "Targeting localization
and function of the RNA helicase DDX5/p68 with
1-(3,5-dimethoxyphenyl)-4-[(6-fluoro-2-methoxyquinoxalin-3-yl)
aminocarbonyl] piperazine (RX-5902)" was co-authored by Frances
Fuller-Pace Ph.D., Division of Cancer Research, University of
Dundee, United Kingdom and Rexahn scientists.
In the present study, Supinoxin™ (RX-5902) was shown to
dose-dependently decrease the migration of human triple negative
breast cancer cells (MDA-MB-231) in a preclinical model of cancer
cell metastasis.
Dr. Fuller-Pace commented, "RX-5902 was effective in blocking
the migration of human triple negative breast cancer cells
(MDA-MB231). This is very encouraging, suggesting its potential
utility for the treatment of malignant tumors."
"We continue to be encouraged by the preclinical and clinical
data seen with Supinoxin™. Phosphorylated p68 appears to be
involved in cancer cell survival and growth as well as tumor
metastasis, suggesting that Supinoxin™ may play a role in treating
difficult cancers such as triple negative breast cancer where
metastatic disease is a common occurrence and is one of the main
factors that impact prognosis," commented Ely Benaim, M.D.,
Rexahn's Chief Medical Officer.
Supinoxin is currently in a Phase I dose-escalation clinical
trial in cancer patients with solid tumors with clinical data
expected in the first half of 2015.
About Supinoxin™ (RX-5902)
Supinoxin™ (RX-5902) is an orally administered, potential
first-in-class, small molecule inhibitor of phosphorylated-p68
(P-p68). P-p68, which is selectively overexpressed in cancer cells
and is absent in normal tissue, increases the activity of multiple
cancer related genes including cyclin D1, c-jun and c-myc, and
plays a role in tumor progression and metastasis. Over-expression
of phosphorylated-p68 has been observed in solid tumors, such as
melanoma, colon, ovarian and lung tumors. In preclinical studies,
Supinoxin has been shown to inhibit proliferation of cells in 18
human cancer cell lines including breast, colon, pancreas, ovarian,
and stomach cancers, and showed potent activity in drug-resistant
cancer cells. In preclinical animal model, where human cancer cells
from melanoma, pancreas, renal or ovarian tumors were grafted into
animals, treatment with Supinoxin resulted in a significant
reduction in tumor growth.
Supinoxin is undergoing a Phase I dose-escalation clinical trial
in cancer patients with solid tumors designed to evaluate the
safety, tolerability, dose-limiting toxicities and maximal
tolerated dose (MTD). Secondary endpoints include pharmacokinetic
analysis and evaluating the preliminary anti-tumor effects of
Supinoxin. This trial is being conducted at 3 clinical oncology
centers in the United States. Each patient has the ability to
continue on the drug up to six cycles of treatment (a dosing cycle
is defined as 3 weeks of drug treatment followed by 1 week off) if
no disease progression is seen. Patients are assessed by CT or MRI
prior to the start of therapy and after every two cycles of therapy
to assess tumor progression. The decision to escalate dose is made
after completion of one cycle of treatment based on safety and
tolerability. Patients have the possibility to receive up to 6
cycles of treatment if the disease does not progress. Tumor biopsy
samples are taken to assess the biomarker phosphorylated-p68.
Patients in seven dose groups (25, 50, 100, 150, 225, 300 and 425
mg) have been enrolled, and the MTD has not yet been reached. In
preliminary pharmacokinetic data, Supinoxin has approximately 51%
oral bioavailability. The ongoing Phase I clinical trial is
expected to be completed in the first half of 2015 once the MTD has
been achieved.
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 cash flow requirements, future operations and products,
enrollments in clinical trials, 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,
the difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance; the
success and design 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.
CONTACT: The Trout Group LLC
Chad Rubin
(646) 378-2953
crubin@troutgroup.com