Clinical study planned for advanced or recurrent solid tumors
PRINCETON, N.J., Aug. 5 /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-1105, for the treatment of patients with selected advanced or recurrent
solid tumors, specifically renal cell carcinoma, melanoma, non-small cell
lung cancer or epithelial ovarian cancer. MDX-1105 is a fully human
antibody that targets the PD-L1 pathway to promote enhanced T-cell immune
responses against cancer and reverse T-cell inactivation in chronic
infectious disease.
The open-label, multi-dose, dose-escalation Phase 1 clinical trial is
expected to enroll up to 46 patients with selected advanced or recurrent
solid tumors. This trial is designed to establish and evaluate the safety,
tolerability and maximum tolerated dose, as well as preliminary
pharmacodynamics and efficacy, of MDX-1105.
"We are pleased that another product candidate from our proprietary
pipeline has progressed into clinical trials," said Howard H. Pien,
President and CEO of Medarex. "We believe that our fully human anti-PD-1
and anti-PD-L1 antibodies represent the next stage in immunotherapy beyond
the anti-CTLA-4 antibodies. We look forward to exploring the potential of
MDX-1105 as a possible new treatment option for patients with cancer and
infectious disease."
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 40 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 3 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 website at http://www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995, 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
"expected"; "potential"; "possible"; or "may"; or similar statements are
forward-looking statements. Medarex disclaims, however, any intent or
obligation to update these forward-looking statements. These risks and
uncertainties include those 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, 2007 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.
 back to top
http://www.prnewswire.com/comp/108265.html /
CONTACT:
Laura S. Choi, Investor Relations, x2216, or
Nichol Harber, Corporate Communications (media) x2214, both of
Medarex, Inc., +1-609-430-2880
|
