Rexahn Pharmaceuticals Provides Update on Phase I Supinoxin Trial in Cancer Patients with Solid Tumors
July 18 2014 - 9:00AM
Business Wire
Patient enrollment on schedule for
completion in Q4 2014
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage
biopharmaceutical company developing best-in-class therapeutics for
the treatment of cancer, today announced an update in its Phase I
multi-center dose-escalation study to evaluate the safety,
tolerability, dose-limiting toxicities and maximum tolerated dose
(MTD) of Supinoxin™ (RX-5902) in cancer patients with solid
tumors.
Enrollment into four dose groups has been completed (25, 50, 100
and 150 mg) and no drug related adverse events have been reported.
The fifth dose group (225 mg) is ongoing. The maximum tolerated
dose of Supinoxin has not yet been achieved. Pharmacokinetic
analysis has shown that Supinoxin displays dose-proportional
exposure and an estimated oral bioavailability of 51%.
“With the fourth dosing group now complete, we continue to be
encouraged by the pharmacokinetics and safety of Supinoxin in
patients who have received multiple cycles of treatment. We are on
schedule to complete enrollment of patients in this clinical trial
by the end of 2014," stated Rexahn's Chief Executive Officer, Peter
D. Suzdak, Ph.D. “We look forward to the data from this trial,
which will further guide the clinical development of this
compound.”
The Phase I trial of Supinoxin, which was initiated in August
2013, is a dose-escalation study designed to evaluate the safety,
tolerability, dose-limiting toxicities and MTD in patients with
solid cancer tumors that have previously failed treatment with
approved therapies and shown progression of disease. Secondary
endpoints include pharmacokinetic analysis and evaluating the
preliminary anti-tumor effects of Supinoxin. This trial is being
conducted in three 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 trial is using an accelerated dose-escalation
design: one patient is treated per dose cycle until a grade 2
related adverse event occurs then three patients will be treated
per dose cycle. The decision to escalate dose is made by the data
monitoring safety board (DMSB) 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 phospho-P68.
About Supinoxin™
(RX-5902)
Supinoxin (RX-5902) is an orally administered, potential
first-in-class, small molecule inhibitor of phosphorylated-p68 RNA
helicase (P-p68). P-p68, which is selectively expressed 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 P-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 cancer 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 an animal model, where human cancer
cells from melanoma, pancreas, renal or ovarian cancers were
grafted into animals, treatment with Supinoxin resulted in a
significant reduction in tumor growth.
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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