NexMed Receives FDA Clearance for PrevOnco™ Phase 2 Study as First-Line Therapy for HCC
26 Abril 2010 - 3:45PM
Business Wire
NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of
products based on the NexACT® technology, today announced that the
U.S. Food & Drug Administration (FDA) has cleared the Company
to proceed with the proposed Phase 2 trial of PrevOnco™, its
proprietary cancer treatment for patients with advanced,
unresectable hepatocellular carcinoma (HCC), or liver cancer. The
FDA granted PrevOnco™ orphan drug status in August 2008, and in
March 2010, NexMed filed its Investigational New Drug (IND)
application for the product candidate.
The Company also noted that in IND review communication, the FDA
has given NexMed the opportunity to move PrevOnco™ directly into a
Phase 3 trial that would support marketing approval, subject to
positive study results. In order to pursue this regulatory path,
NexMed would need to expand the proposed Phase 2 study design to
use PrevOnco™ in combination with Doxorubicin as a second-line
therapy for patients who have failed NEXAVAR®, the currently
marketed first-line anticancer treatment for patients with either
HCC or advanced renal cell carcinoma (cancer of the kidney).
PrevOnco™ incorporates lansoprazole, which is the generic
anti-ulcer compound approved under the name Prevacid® and marketed
in the U.S. by Takeda Pharmaceuticals North America, Inc. In vitro
and in vivo data generated to date has demonstrated the ability of
lansoprazole to inhibit tumor cell growth and enhance survival in
mouse models of cancer alone, and in combination with
Doxorubicin.
Commenting on today’s news, Dr. Bassam Damaj, President and
Chief Executive Officer of NexMed, stated, “We are very pleased
that the FDA agreed with our protocol for the HCC Phase 2 trial for
PrevOnco™ as a first-line therapy for HCC. Additionally, we are
actively assessing the suggestion made by the FDA to move directly
into a Phase 3 trial, by studying PrevOnco™ in combination with
Doxorubicin as a second-line therapy for patients who have failed
NEXAVAR® therapy. Following this path could be very advantageous
for NexMed since advancing the drug directly into a Phase 3 study
would save us at least 12-24 months in development time.”
About Hepatocellular Carcinoma
(HCC)
Hepatocellular carcinoma (HCC) is the seventh most common cancer
in the world, with a high incidence in China and other Asian
countries. Although uncommon in the U.S., there are a reported
8,500 to 11,000 new cases diagnosed each year, comprising 2% of all
malignancies. Cases in the U.S. occur primarily in men of Chinese
descent, a subpopulation which has a high incidence of viral
hepatitis – a known risk factor for HCC.
About NexMed, Inc.
NexMed is the largest specialty CRO based in San Diego, CA and
is one of the industry's most experienced CROs for in vitro and in
vivo pharmacology services and research models. The Company’s goal
is to generate revenues from the growth of its Discovery
Pre-clinical CRO business, while aggressively seeking to monetize
its proprietary NexACT drug delivery technology through
out-licensing agreements with pharmaceutical and biotechnology
companies, worldwide. At the same time, NexMed is actively pursuing
partnering opportunities for its NexACT-based treatments for
onychomycosis, psoriasis, sexual dysfunction and cancer. For
further information on NexMed and its subsidiaries, visit the
following websites: http://www.nexmed.com or
http://www.bio-quant.com.
Forward-Looking Statement Safe
Harbor
Statements under the Private Securities Litigation Reform Act:
with the exception of the historical information contained in this
release, the matters described herein contain forward-looking
statements that involve risks and uncertainties that may
individually or mutually impact the matters herein described for a
variety of reasons that are outside the control of the Company
including but not limited to its ability to develop and license
PrevOnco™ and the ability to design and commence clinical
studies.
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