Rexahn Pharmaceuticals Presents Preliminary Safety and Efficacy Data From Ongoing Phase 2a Clinical Trial of RX-3117 in Combi...
October 02 2018 - 8:00AM
Combination of RX-3117 and Abraxane Appears Safe
and Well-Tolerated When Administered at the Recommended Phase 2
Dose of RX-3117 and the Maximal Labeled Dose of Abraxane
Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage
biopharmaceutical company developing innovative, targeted
therapeutics for the treatment of cancer, today announced
preliminary safety and efficacy data from the ongoing Phase 2a
clinical trial of RX-3117 in combination with Abraxane®
(nab-paclitaxel) in patients newly diagnosed with metastatic
pancreatic cancer. The data are being presented in a poster
presentation titled “RX-3117, A Novel, Oral Nucleoside Analog, in
Combination with Nab-Paclitaxel (nab-pac) in First-line Metastatic
Pancreatic Cancer (met-PC): Safety, Tolerability and Preliminary
Responses” at the 5th NCI Pancreatic Cancer Symposium held October
2-3, 2018 at the National Institutes of Health in Bethesda,
Maryland.
Highlights from the poster reflecting data as of
September 19, 2018:
- Combined administration of RX-3117 and Abraxane in newly
diagnosed pancreatic cancer patients appeared to be safe and
well-tolerated
- The most common (≥20%) adverse events were diarrhea, nausea,
fatigue, alopecia, anorexia and rash
- There were no dose-limiting toxicities
- Combined administration of RX-3117 and Abraxane showed
preliminary signs of efficacy in newly diagnosed metastatic
pancreatic cancer patients. Of the 14 subjects that had at least
one on-study scan (after 2 cycles of therapy):
- One patient experienced a complete response (CR) after 6 cycles
of therapy
- Three patients exhibited a partial response (PR): two after 2
cycles (39-47% tumor reductions) and one after 4 cycles of therapy
(36% tumor reduction)
- An additional eight patients experienced stable disease (SD)
for at least 2 cycles with tumor marker (CA19-9) reductions ranging
between 43-69%
- The disease control rate (CR+PR+SD) for evaluable patients was
86%
- Overall response rate (CR+PR) was 29%
“These preliminary data are encouraging, showing that the
combined administration of RX-3117 and Abraxane in newly diagnosed
metastatic pancreatic cancer patients appears to be safe and well
tolerated and showing evidence of clinical activity,” said Dr. Ely
Benaim, M.D., chief medical officer of Rexahn. “As of
September 19, 2018, there was one complete response and three
partial responses from the first 14 evaluable patients. In
addition, there were eight patients with stable disease who had
tumor reductions of up to 16% and who are still being actively
dosed. We are encouraged by this preliminary data reflecting a
disease control rate of 86% and an overall response rate of 29%. We
look forward to completing the study enrollment and plan to report
the final data in 2019.”
“The safety profile of RX-3117 continues to be encouraging as it
can be administered at its recommended Phase 2 dose together with
the maximal labeled dose of Abraxane without producing an increase
in severe adverse events,” said Peter D. Suzdak, Ph.D., chief
executive officer of Rexahn. “This differs from current standard of
care where the doses of both gemcitabine and Abraxane, when given
in combination, may have to be reduced to avoid grade 3 and 4 dose
limiting toxicities.”
The current trial, which is a multicenter, open-label, 2 stage
Phase 1b/2a study, is designed to assess the safety, tolerability
and efficacy of the combined administration of the maximal labeled
dose of Abraxane and the full Phase 2 dose of RX-3117 in newly
diagnosed metastatic pancreatic cancer patients. Phase 1 was a
dose-finding, open-label study of oral RX-3117 administered in
combination with nab-pac to subjects with newly diagnosed met-PC.
RX-3117 was administered at a dose of 700 mg orally once-daily for
5 consecutive days with 2 days off per week and Abraxane (nab-pac)
was administered at a dose of 125 mg/m2 once weekly for 3 weeks
with 1 week off per 4-week cycle. In stage 1 of the trial, the
combination of RX-3117 and nab-pac appeared to be safe and
well-tolerated and not associated with dose-limiting toxicities
following one cycle of treatment. In stage 2, a total of 40
subjects will be recruited into the study for up to 8 cycles of
combined therapy. Currently there are 14 patients that had at least
one on-study scan (after 2 cycles of therapy) 11 of who are still
receiving treatment in the study. The complete data from these, and
all patients, are expected to be available in the first half of
2019.
A copy of the poster is available on the Company's website at
https://rexahn.com/cms/media-center/publication/posters/.
About RX-3117
RX-3117 is a novel, investigational, oral, small molecule
nucleoside compound. Once intracellularly activated
(phosphorylated) by 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 over
expression 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® (nab-paclitaxel) 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 at: https://rexahn.com/cms/portfolio/rx-3117/.
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a
wholly owned subsidiary of Celgene Corporation.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals, Inc. (NYSE American: RNN) is a clinical
stage biopharmaceutical company dedicated to developing novel,
targeted therapeutics for the treatment of cancer. 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 certain
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-0201. 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.comlradocaj@dgicomm.com
Investor contact:ir@rexahn.com
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