Rexahn Presents Updated Interim Data From Phase 2a Trial of RX-3117 in Advanced Bladder Cancer at the 2019 ASCO GU Symposium
19 Fevereiro 2019 - 10:00AM
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,
presented updated preliminary safety and efficacy data from its
ongoing Phase 2a clinical trial of RX-3117 in advanced urothelial
(bladder) cancer at the 2019 American Society of Clinical Oncology
Genitourinary Cancers (ASCO GU) Symposium on February 15, 2019.
The poster presentation reports updated interim data from the
Phase 2a trial of RX-3117 monotherapy in advanced bladder cancer. A
total of 35 patients with advanced bladder cancer have been
enrolled into the study, 91% of whom had received two or more prior
cytotoxic therapies, including gemcitabine (89% of patients) and
immunotherapy (77% of patients). Thirty-one patients had at least
one scan on treatment and were therefore included in the
preliminary efficacy analysis. One patient had a complete response
and remains on treatment after 14 months. Five patients had stable
disease for at least four months, two of whom stayed in the trial
for six months or longer. RX-3117 appears to be safe and
well-tolerated. Mild to moderate fatigue and diarrhea are the most
common side effects observed in the trial to date.
“Patients with advanced bladder cancer, who have already
developed resistance to gemcitabine and have progressed on
immunotherapy, have very limited treatment options,” said Ely
Benaim, M.D., chief medical officer of Rexahn. “We are encouraged
to see preliminary signs of efficacy in this study, including a
complete response and disease stabilizations. There is nothing
approved for third-line treatment of bladder cancer and as a
result, these patients are usually transferred to palliative and
supportive care.”
The Phase 2a clinical trial is a multicenter, open-label
single-agent study of RX-3117 conducted at clinical centers in the
United States. Patients received a 700 mg daily oral dose of
RX-3117, five times weekly on a three weeks on, one week off dosing
schedule or four week continuous dosing in each 28 day cycle.
Treatment continued for up to eight cycles or until disease
progression. The primary endpoints are progression-free survival
and objective clinical response.
Rexahn also presented final data from the discontinued study of
RX-0201 (Archexin®) in advanced renal cell carcinoma at the
symposium. Copies of the ASCO GU posters 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 as a monotherapy in 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
at: https://www.rexahn.com/product-pipeline/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
https://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 timing, progress, results and other matters
regarding our ongoing clinical trial of RX-3117 in combination with
ABRAXANE®; expectations regarding the potential effectiveness and
safety of Rexahn’s product candidates, including RX-3117 in
combination with ABRAXANE; future operations; 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; preliminary indications of efficacy
not being demonstrated in final study results; the ability to
initially develop drug candidates for orphan indications to 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 press 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.comlradocaj@dgicomm.com
Investor Contact:ir@rexahn.com
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