Three clinical trials ongoing with key
milestones expected in Q4 2014
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage
biopharmaceutical company developing best-in-class therapeutics for
the treatment of cancer, is providing an overview of its three
clinical development programs and financial results for the quarter
ended March 31, 2014.
“We continue to enroll patients in each of our three clinical
trials as expected, and as planned for,” stated Rexahn’s Chief
Executive Officer, Peter D Suzdak, Ph.D. “By the end of 2014, we
expect to achieve key milestones in each trial. In the fourth
quarter we expect to have data from our Phase I trial of Supinoxin™
in cancer patients with solid tumors. We are also scheduled to
complete enrollment of patients in our Phase Ib clinical trial of
RX-3117 by the end of 2014. During the fourth quarter of this year,
we anticipate completing the safety portion of our Phase II trial
for metastatic renal cell carcinoma.”
Pipeline Update:
Supinoxin™ (RX-5902)
The Company initiated a Phase I clinical trial of Supinoxin in
cancer patients with solid tumors in August 2013, which is ongoing
and is expected to be completed in the fourth quarter of 2014. In
March, the Company announced the initial results from the trial.
The maximum tolerated dose (MTD) of Supinoxin 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) is ongoing. Pharmacokinetic analysis
has shown that Supinoxin 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.
RX-3117
Rexahn initiated a Phase Ib clinical trial of RX-3117 in cancer
patients with solid tumors in December 2013. The Company expects to
complete patient enrollment for the trial in the fourth quarter of
2014 or early 2015. The Phase Ib trial is a multi-center
dose-escalation study which will evaluate the safety, tolerability,
dose-limiting toxicities and MTD of RX-3117 in patients with solid
tumors. Secondary endpoints will include characterizing the
pharmacokinetic profile of RX-3117 and evaluating the preliminary
anti-tumor effects of RX-3117. Rexahn has completed one dose cycle
(30 mg) and is in the middle of the second dose cycle (100mg).
Archexin®
Rexahn continues to enroll metastatic renal cell carcinoma
patients in its Phase IIa proof-of-concept clinical trial for
Archexin. Rexahn has previously received orphan drug designation
for this indication. The trial is a multi-center study designed to
evaluate the efficacy of Archexin in combination with everolimus
(Afinitor®) to treat metastatic RCC patients and will be conducted
in two stages. The first stage will be dose ranging, with up to
three cohorts of three RCC patients to determine its MTD in
combination with everolimus. Once the MTD has been determined,
thirty RCC patients will be randomized to either Archexin in
combination with everolimus or everolimus alone, in a ratio of 2:1.
Rexahn plans to complete the initial safety component of this study
in the fourth quarter of 2014.
Additional Highlights from First
Quarter 2014:
- Presented data on RX-3117 and RX-21101
at the 2014 American Association for Clinical Research Annual
Meeting.
- Announced the appointment of Mark P.
Carthy to Rexahn’s Board of Directors. Mr. Carthy is the Managing
Partner of Orion Equity Partners, LLC, a healthcare venture capital
management and advisory firm co-founded by Mr. Carthy in 2008.
- Completed a registered direct offering
for aggregate gross proceeds of $20 million. The proceeds of this
offering will be used to further research and development of
Rexahn’s pipeline.
Financial Update:
Cash Position - Rexahn’s cash and investments totaled
$40.3 million as of March 31, 2014, compared to $19.0 million as of
December 31, 2013. The increase of $21.3 million was primarily due
to the issuance of common stock and the exercise of warrants and
stock options to purchase common stock totaling $23.9 million,
which amount was offset by $2.6 million of net cash used in
operating activities. Rexahn expects that its cash and cash
equivalents balance as of March 31, 2014 will be sufficient to fund
the Company’s operations into the first half of 2016.
R&D Expenses - Research and development expenses were
$1.3 million for the first quarter of 2014, compared to $0.6
million for the first quarter of 2013. The increase is primarily
attributable to the clinical trials that were ongoing during the
three months ended March 31, 2014.
G&A Expenses - General and administrative expenses
were $1.4 million for the first quarter of 2014, compared to $1.2
million for the first quarter of 2013. The increase is attributable
to increases in investor relations and financial advisory services
relating to the Company’s financing activities.
Net Loss – Rexahn’s net loss was $14.6 million, or $0.09
per share, for the first quarter of 2014, compared to a net loss of
$1.5 million, or $0.01 per share, for the comparable period in
2013. Included in the net loss for the first quarter was a non-cash
charge of $11.7 million due to an adjustment to the fair value of
outstanding warrants resulting from the increased stock price of
the underlying common stock, as compared to a non-cash gain of $0.4
million in the first quarter of 2013.
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 RX-3117
RX-3117 is a small molecule nucleoside analog that is activated
(phosphorylated) by the enzyme Uridine Cytidine Kinase (UCK) and
inhibits both DNA and RNA synthesis, which induces apoptotic cell
death of tumor cells. UCK is overexpressed in multiple human
tumors, but has a limited presence in normal tissues. This unique
specificity for cancer cells may lead to an improved efficacy and
safety profile in cancer patients. RX-3117 also mediates the down
regulation of DNA methyltransferase 1 (DNMT1), an enzyme
responsible for the methylation of cytosine residues on newly
synthesized DNA and also a target for anticancer therapies.
Preclinical studies have shown RX-3117 to be effective in both
inhibiting the growth of various human cancer xenograft models,
including colon, lung, renal and pancreas, as well as overcoming
chemotherapeutic drug resistance.
RX-3117 has demonstrated a broad spectrum anti-tumor activity
against 50 different human cancer cell lines and efficacy in 12
different mouse xenograft models. The efficacy in the mouse
xenograft models was superior to that of gemcitabine. In addition,
RX-3117 still retains its full anti-tumor activity in human cancer
cell lines made resistant to the anti-tumor effects of gemcitabine.
In August 2012, Rexahn reported the completion of an exploratory
Phase I clinical trial of RX-3117 in cancer patients conducted in
Europe, to investigate the oral bioavailability, safety and
tolerability of the compound. In this study, oral administration of
RX-3117 demonstrated an oral bioavailability of 56% and a plasma
half-life (T1/2) of 14 hours. In addition, RX-3117 was safe and
well tolerated in all subjects throughout the dose range
tested.
About Archexin®
Archexin is a unique anti-cancer drug candidate which inhibits
the cancer cell signaling protein Akt-1, which is involved in
cancer cell growth, survival, angiogenesis, and drug resistance.
Rexahn has completed a Phase I clinical trial of Archexin in cancer
patients with solid tumors and was shown to be safe and well
tolerated. The dose-limiting toxicity was a grade 3 fatigue. In a
small Phase IIa trial in advanced pancreatic cancer patients,
Archexin in combination with gemcitabine was shown to be safe and
well tolerated and demonstrated a preliminary efficacy signal with
a median survival of 9.1 months in evaluable patients.
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
Rexahn Pharmaceuticals, Inc. (AMEX:RNN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Rexahn Pharmaceuticals, Inc. (AMEX:RNN)
Historical Stock Chart
From Apr 2023 to Apr 2024