- Supinoxin™ Phase I clinical trial
enters fourth dosing group; preliminary data announced in March
2014
- Archexin® Phase IIa clinical trial
initiated in metastatic renal cell carcinoma
- RX-3117 Phase Ib clinical trial
initiated
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 year
ended December 31, 2013.
“Last year was a year of transition for Rexahn as we re-focused
our efforts to build a pipeline of oncology assets and raised a
significant amount of capital to support the clinical development
of our three programs,” commented Rexahn’s Chief Executive Officer,
Peter D. Suzdak, Ph.D. “We are very excited about the progress of
the Supinoxin™, RX-3117, and Archexin® clinical development
programs, and we believe that 2014 will be a transformational year
for Rexahn with clinical data expected from all three programs. I
look forward to updating our shareholders on the upcoming
milestones as appropriate and appreciate their support.”
Pipeline Update:
Supinoxin™ (RX-5902)
A Phase I dose-escalation clinical trial of Supinoxin (RX-5902)
in cancer patients with solid tumors began enrolling patients in
August 2013. The study is still ongoing and the maximum 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 two cycles of treatment, and
one patient has received six cycles of treatment. 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. Rexahn expects to complete this trial
and announce final results in the fourth quarter of 2014.
RX-3117
Rexahn initiated a Phase Ib clinical trial of RX-3117 in cancer
patients with solid tumors in January 2014. 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 cancer
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
expects to complete patient enrollment of the RX-3117 Phase I
clinical trial in the fourth quarter of 2014 or early 2015.
Archexin®
Rexahn initiated a Phase IIa Archexin proof-of-concept clinical
trial in patients with metastatic renal cell carcinoma (RCC) in
January 2014. 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 for treatment with either
Archexin in combination with everolimus or everolimus alone, in a
ratio of 2:1. Rexahn plans to complete the initial component of
this trial in the fourth quarter of 2014.
Additional Highlights from 2013:
- Announced the appointment of Dr. Peter
D. Suzdak as Chief Executive Officer. Prior to joining Rexahn, Dr.
Suzdak was Chief Scientific Officer of Corridor Pharmaceuticals and
co-Founder, founding Chief Executive Officer and Chief Scientific
Officer of Cardioxyl Pharmaceuticals.
- Presented mechanism of action data for
RX-5902 at the American Association for Cancer Research (AACR)
Annual Meeting in April.
- In-licensed two novel drug delivery
platforms, Nano-Polymer-Drug Conjugate Systems (NPDCS) and
Lipid-Coated Albumin Nanoparticle (LCAN). These technologies target
the delivery of chemotherapeutic agents directly into cancerous
tumors.
Financial Update:
For the year ended December 31, 2013, total operating expenses
were $8.0 million. Rexahn’s cash and investments totaled $19.0
million as of December 31, 2013, as compared to $14.7 million on
December 31, 2012. The increase of $4.3 million was primarily due
to $12.3 million from the issuance of common stock and the exercise
of stock warrants and options, offset by $8.0 million of net cash
used in operating activities.
On July 26, 2013, Rexahn completed a $5.7 million registered
direct offering of common stock and warrants at an offering price
of $0.50 per unit. On October 16, 2013, Rexahn completed a $5.3
million registered direct offering of common stock and warrants at
an offering price of $0.52 per unit. Additionally, on January 15,
2014, Rexahn completed a $20.0 million registered direct offering
of common stock and warrants at an offering price of $1.05 per
unit. The proceeds of this offering will be used for further
research and development of Rexahn’s pipeline. As of March 21,
2014, Rexahn’s cash and investments totaled approximately $40.3
million (unaudited).
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. 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 nucleoside analog that is activated
(phosphorylated) by 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 safety profile in cancer
patients. RX-3117 also mediates the downregulation 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, and 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.
These findings have either been previously presented at the
American Association of Cancer Research Meeting in 2012 or will be
the subject of a peer reviewed publication to be published in early
2014. 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 potential best-in-class anti-sense drug candidate
that specifically inhibits the cancer cell signaling protein Akt-1.
Archexin is the only specific inhibitor of Akt-1 in clinical
development. The activated form of Akt-1, which is involved in
cancer cell growth, survival, angiogenesis, and drug resistance,
has shown to be present or elevated in more than 12 different human
cancer cell lines, including pancreatic and renal cell carcinoma.
By inhibiting Akt-1, Archexin has shown to both inhibit the growth
of human renal cell carcinoma cell lines and exhibit a longer
survival benefit in the human renal cell carcinoma animal xenograft
model. We believe that, while Akt-1 is a very specific anti-cancer
target, Archexin may have broad therapeutic potential across
multiple types of cancer. Archexin has completed a Phase I clinical
trial 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. It 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
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