Rexahn Initiates Phase IIa Clinical Trial of Archexin® in Patients with Metastatic Renal Cell Carcinoma
January 14 2014 - 9:00AM
Business Wire
FDA has Granted Orphan Drug Designation for
Renal Cell Carcinoma
Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage
biopharmaceutical company, announced today the initiation of a
Phase IIa clinical proof-of-concept trial to study the safety and
efficacy of Archexin® in patients with metastatic renal cell
carcinoma (RCC). Archexin was previously granted Orphan Drug
Designation for the RCC indication.
The Phase IIa Archexin proof-of-concept clinical 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. Stage 1 will be dose
ranging with up to 3 cohorts of 3 RCC patients to determine its
maximum tolerated dose in combination with everolimus. Based on
previous clinical data the target dose of Archexin is anticipated
to be no more than 250 mg/m2 per day. The decision to enroll the
next group of patients and escalate the dose will be made after
completion of the first 21 day cycle of treatment. Patient
assessments will include safety, pharmacokinetics, laboratory and
physical exams. Once the maximum tolerated dose of Archexin in
combination with everolimus 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.
The primary endpoint will be the percentage of progression free
patients following eight cycles of therapy. Patients will be
scanned (CT or MRI) for the assessment of tumor progression after
every 2 cycles of therapy. Secondary endpoints include
pharmacokinetic profile, incidence of adverse events, changes in
clinical laboratory tests and vital signs over time, tumor
response, duration of response, time to response, and response
rate. Exploratory endpoints will include blood levels of AKT
pathway biomarkers, tumor apoptosis biomarkers or other relevant
biomarkers.
Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer
commented, “The start of the Phase IIa clinical-proof-of-concept
trial in RCC patients represents an important milestone for the
Archexin clinical development program. The combination of strong
scientific data, unmet clinical need, and our Orphan Drug
Designation were all driving factors for choosing this
indication.”
Archexin is a specific inhibitor of the cancer cell signaling
protein Akt-1. The activated form of Akt-1 (phospho-Akt-1) has been
shown to be involved in cancer cell growth, survival, angiogenesis,
and drug resistance. Phospho-Akt-1 has been shown to be
significantly increased in more than 12 different human cancer cell
lines including human renal cell carcinoma cells. Archexin has
shown to inhibit the growth of human RCC cells in tissue culture
and produce a substantial survival benefit in animal xenograft
models of RCC. Archexin also exhibits additive anti-tumor effect
when combined with other cancer drugs in inhibiting the growth of
human RRC cells in tissue culture. In addition, resistance to the
anti-cancer effects of clinically used mTOR inhibitors such as
everolimus (Afinitor®), which is used as second line therapy in RCC
patients, has been attributed to an increase in Akt-1 activity.
Thus, treatment with Archexin may both inhibit the
growth/proliferation of RCC and overcome the resistance to mTOR
inhibitors such as everolimus, resulting in an increase in
efficacy.
Dr. Neeraj Agarwal MD, Director, GU Medical Oncology, Huntsman
Cancer Institute, University of Utah, Salt Lake City, Utah, “The
treatment of patients with metastatic RCC remains a significant
unmet medical need. Selective Akt-1 inhibition represents a very
promising new mechanism for the treatment of metastatic RCC. The
potential to both inhibit the growth of RCC cells and affect the
underlying mechanism responsible for the development of tolerance
to second line therapies such as everolimus is very promising.”
About Archexin®
Following a comprehensive scientific, clinical and business
analysis of potential cancer indications for a new Phase IIa
clinical trial with Archexin, Rexahn decided to pursue metastatic
RCC. Metastatic RCC represents an attractive market opportunity
with an estimated annual incidence of 90,000 patients world-wide
and projected 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
received the U.S. Food and Drug Administration’s (FDA) Orphan Drug
Designation for Archexin for metastatic RCC as well as four other
cancers including pancreatic cancer.
Archexin is a unique 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. 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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