NexMed to Present PrevOnco® Data at ILCA Annual Conference
June 28 2010 - 11:09AM
Business Wire
NexMed, Inc. (Nasdaq: NEXMD), a specialty CRO with a pipeline of
product candidates based on the NexACT® technology, today announced
that the Company will present data at the International Liver
Cancer Association (ILCA) Fourth Annual Conference from September
10-12, 2010 in Montreal, Canada. The presentation, entitled,
“PrevOnco® Exhibits In Vitro Cytolytic Activity, Prolongs Survival
in Kidney Cancer and Leukemia Models and Reduces Tumor Growth Rates
Alone and in Concert in a Liver Cancer Model,” is scheduled to be
presented by Bassam Damaj, Ph.D., President and Chief Executive
Officer of NexMed, on Saturday, September 11, 2010 from 2:30 - 4:30
p.m.
PrevOnco is NexMed’s proprietary cancer treatment for patients
with advanced, unresectable hepatocellular carcinoma (HCC), or
liver cancer, and was granted orphan drug status by the U.S. Food
& Drug Administration (FDA) in August 2008. 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.
In March 2010, NexMed filed an Investigation New Drug (IND)
application for PrevOnco. In April 2010, the FDA cleared the
Company’s protocol to test the product in a Phase 2 study as a
first line therapy for HCC. In the same IND communication, the FDA
gave 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).
Dr. Damaj stated, “This is the first time that PrevOnco data
will be presented for peer review at a leading industry conference.
The product has generated significant interest, as patients who
have HCC and fail the currently marketed first-line treatment
currently have no other viable alternative. Given the potential of
this product candidate, we remain in active discussions with the
FDA about the protocol design for testing our product in a larger
scale Phase 3 study.”
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
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. For
example, and without limitation, there can be no assurance that
PrevOnco will be successful in clinical testing, or the FDA will
approve it for marketing.
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