- Supinoxin™ Phase I clinical trial
enters third dosing group; preliminary data expected in the first
quarter of 2014
- Lead indication, metastatic renal cell
carcinoma, chosen for Archexin® Phase IIa trial to begin December
2013
Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage
biopharmaceutical company developing best-in-class therapeutics for
the treatment of cancer is providing a quarterly update today on
its three clinical development programs and financial results.
“We are excited about the progress of the Supinoxin™, RX-3117
and Archexin® clinical development programs. As we continue through
the end of 2013, and into the first quarter of 2014, we look
forward to updating our shareholders on the initiation of the Phase
I clinical trial with RX-3117, the initiation of the Phase IIa
clinical trial with Archexin in metastatic renal cell carcinoma,
and the initial clinical data from the Phase I clinical trial with
Supinoxin,” commented Rexahn’s Chief Executive Officer Peter D.
Suzdak, PhD. “We are also pleased that we were able to strengthen
the balance sheet recently which will allow us to increase the
momentum for the clinical development of our pipeline.”
Pipeline Update:
Supinoxin™ (RX-5902)
The Phase I dose-escalation clinical trial of Supinoxin
(RX-5902) in cancer patients with solid tumors began enrolling
patients in August 2013. Patient enrollment in the third dosing
group was recently initiated, and Rexahn anticipates updating
investors with available clinical data from this trial by the end
of the first quarter of 2014. The Phase I trial is designed to
evaluate the safety, tolerability, and the maximal tolerated dose
of Supinoxin. This evaluation is being conducted in three clinical
oncology centers in the United States. Each patient has the ability
to continue on the drug up to six cycles of treatment. Patients are
assessed by CT or MRI prior to the start of therapy and after every
two cycles of therapy to track tumor progression.
RX-3117
Rexahn is preparing to initiate a Phase I clinical trial of
RX-3117 in cancer patients with solid tumors in December 2013. The
design of this study is based partially on the initial data
obtained in an exploratory Phase I clinical trial of RX-3117 in
cancer patients conducted in Europe in 2012. This upcoming
dose-escalation clinical trial will be conducted in multiple
clinical sites in the U.S. for cancer patients with solid tumors.
Patients will receive RX-3117 orally three times a week for three
weeks followed by one week off. Patients will have the ability to
continue on the drug up to eight cycles of treatment. The decision
to enroll the next group of patients and escalate the dose will be
made after one cycle of treatment, based on safety and
tolerability. Patients will be assessed for tumor progression by CT
or MRI prior to the start of therapy and after every two cycles of
therapy.
Rexahn is in active discussions with potential licensing
partners for RX-3117 and will update the financial community as
appropriate.
In September 2013, Prof. Dr. Godefridus J. (Frits) Peters, Head
Laboratory Medical Oncology, VU University Medical Center,
Amsterdam, The Netherlands, published a peer reviewed publication
entitled “Metabolism, mechanism of action and sensitivity profile
of fluorocyclopentenylcytosine (RX-3117)” in the medical journal,
Investigational New Drugs.
Archexin®
Following a comprehensive scientific, clinical and business
analysis of potential cancer indications for a new Phase IIa
clinical trial with Archexin®, Rexahn has decided to pursue
metastatic renal cell carcinoma (RCC). Metastatic RCC represents an
attractive market opportunity with an estimated annual incidence of
90,000 patients world-wide and potential market size of greater
than $6 billion. Metastatic RCC patients receiving standard of care
treatment have a poor prognosis with an overall survival of less
than 2 years. Rexahn has been working with key opinion leaders to
finalize the design of a Phase IIa clinical trial and anticipates
initiating the clinical trial in December 2013.
In preclinical studies, Archexin has shown to inhibit the growth
of human RCC cells in both tissue cultures and in animal xenograft
models. In addition, Archexin may have the ability to prevent the
development of resistance to existing therapies for RCC. Rexahn has
received the U.S. Food and Drug Administration’s Orphan Drug
Designation for this indication.
“We’ve worked with our scientific advisory board and key opinion
leaders to select RCC as the optimal first treatment indication to
pursue for our Phase IIa trial of Archexin. The combination of
strong scientific data, addressable market, unmet clinical need,
and our Orphan Drug Designation were all driving factors for
choosing this indication,” commented Dr. Suzdak. "We are preparing
to initiate our trial next month.”
Financial Update:
For the nine month period ending September 30, 2013, total
operating expenses were $5.6 million. Rexahn’s cash and cash
equivalents including marketable securities and restricted cash as
of September 30, 2013 totaled approximately $15.5 million. In
addition, on October 16, 2013, Rexahn completed a $5.3 million
registered direct offering for a purchase price of $0.52 per share.
The proceeds of this offering will be used for further research and
development of the Company’s pipeline.
About Supinoxin™
(RX-5902)
Supinoxin is an orally administered, 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.
About RX-3117
RX-3117 is a novel small molecule anti-metabolite that is
incorporated into DNA or RNA of cells. It inhibits both DNA and RNA
synthesis which induces apoptotic cell death of tumor cells.
RX-3117 mediates the downregulation of DNA methyltransferase 1
(DNMT1), which is an enzyme responsible for the methylation of
cytosine residues on newly synthesized DNA and is a target for
anti-cancer 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.
These findings have either been previously presented at the
American Association of Cancer Research Meeting in 2012, or were
the subject of a peer reviewed publication released in September
2013. In August 2012, Rexahn reported the completion of an
exploratory Phase I clinical trial of RX-3117 in cancer patients
conducted in Europe. The trial investigated 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 that inhibits
the cancer cell signaling protein Akt-1. 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 decrease the growth of human renal cell
carcinoma in animal xenograft models. Thus, while Akt-1 is a very
specific anti-cancer target it 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 timing and success of clinical
testing; the timing of the conduct of clinical testing; the timing
of the receipt and disclosure of clinical data 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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