Continued Progress in the RX-3117, Supinoxin
and Archexin Clinical Development Programs
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 June 30, 2014.
“We are pleased with the continued progress of the RX-3117,
Supinoxin™ and Archexin® clinical development programs,”
stated Rexahn’s Chief Executive Officer Peter D. Suzdak, PhD.
“Positive data from these studies would be major milestones and
will help direct the next steps for the Company.”
Pipeline Update:
Supinoxin™ (RX-5902)
In August 2013, Rexahn initiated a Phase I dose-escalation study
of Supinoxin designed to evaluate the safety, tolerability,
dose-limiting toxicities and maximal tolerated dose (MTD) in cancer
patients with solid tumors that have previously failed treatment
with approved therapies. Secondary endpoints include
pharmacokinetic analysis and evaluating the preliminary anti-tumor
effects of Supinoxin. In July, Rexahn announced that four dose
groups (25, 50, 100 and 150 mg) had been enrolled. The Company is
currently enrolling patients for its fifth dose group (225 mg), and
the MTD has not yet been achieved. Depending upon the number of
dose groups needed to determine the MTD, Rexahn expects to complete
this trial 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 clinical
trial is a multi-center dose-escalation study that 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. Patient
enrollment has been completed in three dose groups (30, 60 and 100
mg) and is in the middle of recruitment for the fourth dose group
(150 mg). The MTD of RX-3117 has not yet been achieved. The Company
expects to complete patient enrollment of the RX-3117 Phase Ib
clinical trial late in the fourth quarter of 2014 or early 2015.
Based on the progress of the RX-3117 clinical development program
and the level of interest expressed from a number of
oncology-focused pharmaceutical companies, Rexahn is continuing its
discussions with multiple companies to explore collaborative
business structures in an effort to maximize the potential upside
value of the program.
Archexin®
The Phase IIa proof-of-concept clinical trial of Archexin in
metastatic renal cell carcinoma (RCC) patients is ongoing. The
first stage of this study is dose ranging, with up to three dose
groups with three RCC patients each, to determine its MTD of
Archexin in combination with everolimus, an FDA approved drug for
the treatment of RCC. 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 expects
to complete the initial safety component of this study late in the
fourth quarter of 2014 or early 2015.
Additional Highlights from Second Quarter 2014:
- Presented preclinical results for
RX-21101, the Company's first development candidate derived from
its Nano-Polymer-Drug Conjugate System (NPDCS) platform at the
American Association for Cancer Research (AACR) Annual Meeting
2014.
- Announced additional data from
preclinical studies on the anti-tumor effects of RX-3117,
demonstrating that oral administration of RX-3117 inhibited tumor
growth in 12 different human cancer xenograft models.
Financial Update:
Cash Position - Rexahn's cash and investments totaled
$38.3 million as of June 30, 2014, compared to $40.3 million as of
March 31, 2014. The decrease of $2.0 million was primarily due to
$2.9 million of net cash used in operating activities, which amount
was offset by $0.9 million from the exercise of stock warrants and
options to purchase common stock. Rexahn expects that its cash and
cash equivalents as of June 30, 2014 will be sufficient to fund the
Company's cash flow requirements for its current activities into
the second half of 2016.
R&D Expenses - Research and development expenses were
approximately $1.7 million for the second quarter of 2014, compared
to approximately $1.3 million for the first quarter of 2014. The
increase is primarily attributable to the clinical trials that were
started in the first quarter, but continued into the second
quarter. Research and development expenses were $3.0 million for
the six months ended June 30, 2014, compared to $1.5 million for
the six months ended June 30, 2013. The increase was primarily
attributable to expenses related to additional clinical studies in
2014.
G&A Expenses - General and administrative expenses
were approximately $1.7 million for the second quarter of 2014,
compared to approximately $1.4 million for the first quarter of
2014. The increase is primarily related to expenses related to the
shareholder meeting held in the second quarter, and an increase in
legal and professional fees related to corporate organizational
matters. General and administrative expenses for the six months
ended June 30, 2014 were approximately $3.1 million compared to
$2.1 million in the six months ended June 30, 2013. The increase
was primarily attributable to an increase in investor relations and
financial advisory services relating to the Company's financing
activities and additional legal and professional fees.
Net Income (Loss) - Rexahn's net income was $0.2 million,
or $0.00 per share, for the three months ended June 30, 2014,
compared to a net loss of $14.6 million, or $0.09 per share, for
the three months ended March 31, 2014. Included in net income
(loss) for the three months ended June 30 and March 31, 2014 is an
unrealized gain (loss) on the fair value of warrants of $3.7
million and ($11.7 million), respectively. The fair value
adjustments are primarily a result of the changes in the stock
price between reporting periods. Rexahn’s loss from operations was
$3.5 million and $2.8 million for the three months ended June 30
and March 31, 2014, respectively.
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 and inhibits both DNA and RNA
synthesis which induces apoptotic cell death of tumor cells.
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, 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 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 unique anti-cancer drug candidate that inhibits
the cancer cell signaling protein Akt-1, which is involved in
cancer cell growth, survival, angiogenesis, and drug resistance.
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 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 cash flow requirements, future operations and products,
enrollments in clinical trials, 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,
the difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance; the
success and design 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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