Rexahn Announces Initial Results from Phase I Trial of SupinoxinTM (RX-5902) for Solid Cancer Tumors
March 11 2014 - 8:00AM
Business Wire
SupinoxinTM is safe and well tolerated over the
dose range tested in cancer patients
Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage
biopharmaceutical company announced today initial data for the
Phase I dose-escalation clinical trial of SupinoxinTM (RX-5902)
initiated in August 2013. This trial was designed to study safety
and efficacy in patients with solid cancer tumors.
The study is still ongoing and the maximal tolerated dose (MTD)
has not yet been achieved. Three dosing cycles have been completed
(25, 50 and 100 mg) and no drug related adverse events have been
reported. The fourth dosing cycle (150 mg) has been initiated. Two
patients have received 2 cycles of treatment and one patient has
received 6 cycles of treatment. Pharmacokinetic analysis has shown
that SupinoxinTM displays dose-proportional exposure and an
estimated oral bioavailability of 51%. The pharmacokinetic profile
of Supinoxin is similar to what has been seen in preclinical
studies.
Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer
commented, “We are encouraged that Supinoxin is safe and
well-tolerated over the dose range tested in cancer patients with
solid tumors who have received multiple cycles of treatment. In
addition, the pharmacokinetic profile and oral bioavailability of
Supinoxin is consistent with preclinical studies. These data are
very encouraging, and we look forward to sharing additional data
from the trial when it is completed later this year.”
The Phase I trial of Supinoxin, which was initiated in August
2013, is a dose-escalation study which will 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 and 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 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
Supinoxin (RX-5902) is an orally administered, 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.
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 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-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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