PRINCETON, N.J., Jan. 8 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) announced today the allowance of an investigational new drug
application (IND) filed with the U.S. Food & Drug Administration (FDA) for
MDX-1411 for the treatment of CD70-expressing malignancies, with the
initial clinical study to focus on the treatment of clear cell renal cell
carcinoma (ccRCC). MDX-1411 was generated by Medarex's UltiMAb Human
Antibody Development System(R).
The open-label, multi-center, dose-escalation, multi-dose Phase I
clinical trial is expected to enroll up to 40 patients with advanced ccRCC.
The trial is designed to determine the safety, tolerability and maximum
tolerated dose of MDX-1411 as well as characterize preliminary efficacy and
pharmacokinetics.
"The advancement of this antibody into the clinical trial process adds
to our internal pipeline and expands our portfolio of potentially new
oncology therapeutics," said Howard H. Pien, President and CEO of Medarex.
"We expect the growth of our pipeline to continue through the addition of
proprietary products along with new antibodies that are developed through
collaborations."
About MDX-1411
MDX-1411 is a fully human monoclonal antibody that targets the CD70
receptor, which is a member of the tumor necrosis factor (TNF) family. CD70
is expressed in a number of cancers, including ccRCC primary tumors and
metastatic lesions. Preclinical in vitro studies showed that MDX-1411 binds
to CD70 positive cells and induces antibody-dependent cellular cytotoxicity
(ADCC), an important mechanism of action of therapeutic antibodies that
induces the destruction of targeted cells by the immune system. Preclinical
in vivo studies conducted in ccRCC xenograft models demonstrated anti-tumor
activity.
About Renal Cell Carcinoma (RCC)
According to the American Cancer Society there were almost 39,000 new
cases of RCC and 13,000 deaths caused by RCC in 2006. About 80% of RCC
cases are clear cell renal cell carcinoma making it the most common among
five types of RCC. Renal cell carcinoma generally starts as one or more
tumors in one or both kidneys and in advanced stages can spread to other
organs. Current treatment options for RCC include surgery, radiation,
chemotherapy, immunotherapy and targeted therapeutics.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize
a broad range of fully human antibody product candidates for itself and its
partners. More than 30 of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase III clinical trials or the subject of regulatory
applications for marketing authorization. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more information about Medarex, visit
its Web site at http://www.medarex.com.
Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements that are subject
to certain risks and uncertainties that could cause actual results to
differ materially from any future results, performance or achievements
expressed or implied by such statements. Statements that are not historical
facts, including statements preceded by, followed by, or that include the
words "potential"; "expect"; "could"; "may"; or similar statements are
forward-looking statements. Medarex disclaims, however, any intent or
obligation to update these forward-looking statements. Risks and
uncertainties include risks associated with product discovery and
development, uncertainties related to the outcome of clinical trials,
slower than expected rates of patient recruitment, unforeseen safety issues
resulting from the administration of MDX-1411 in patients, uncertainties
related to product manufacturing as well as risks detailed from time to
time in Medarex's public disclosure filings with the U.S. Securities and
Exchange Commission (SEC), including its Annual Report on Form 10-K for the
fiscal year ended December 31, 2006 and its quarterly reports on Form 10-Q.
There can be no assurance that such development efforts will succeed or
that other developed products will receive required regulatory clearance or
that, even if such regulatory clearance were received, such products would
ultimately achieve commercial success. Copies of Medarex's public
disclosure filings are available from its investor relations department.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved.
SOURCE Medarex, Inc.
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Related links:
http://www.medarex.com/
http://www.prnewswire.com/comp/108265.html/
CONTACT:
Laura S. Choi, Investor Relations,
+1-609-430-2880, x2216, or Jean Mantuano, Corporate
Communications (media), +1-609-430-2880, x2221, both of Medarex,
Inc.
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