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.
Copyright Business Wire 2014