Medarex Announces Clinical Data for MDX-1401 in Hodgkin's Lymphoma at Annual Meeting...

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Mon Apr 20, 2009 8:00am EDT

Medarex Announces Clinical Data for MDX-1401 in Hodgkin's Lymphoma at Annual
Meeting of the American Association for Cancer Research

PRINCETON, N.J., April 20 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq:
MEDX) today announced preliminary data from an ongoing Phase 1 clinical trial
of MDX-1401 in patients with relapsed or refractory Hodgkin's lymphoma (HL)
that demonstrated both clinical and immunological activity signals.  MDX-1401
is a fully human, non-fucosylated antibody that targets CD30, a marker for
activated lymphocytes that is present on malignant cells of HL as well as
other CD30-expressing cancers.  Results from the study were presented in a
poster session (Abstract #1227) at the Annual Meeting of the American
Association for Cancer Research (AACR), held April 18-22, 2009 in Colorado.

An ongoing multi-dose, dose-escalation Phase 1 trial of MDX-1401 in patients
with relapsed or refractory HL is being conducted to establish and evaluate
the safety profile and initial efficacy of MDX-1401. Preliminary data from the
Phase 1 trial demonstrate that multiple doses (ranging from 0.01 to 1.0 mg/kg)
of MDX-1401 in patients with HL were generally safe and well-tolerated. Two of
the 8 patients with stable disease had a reduction of 40 percent or more in
tumor burden after two treatment cycles of MDX-1401. In addition, flow
cytometry indicated decreased circulating CD30 positive cells in 83 percent of
patients (10/12) after one cycle of four weekly intravenous infusions. 

"We find these preliminary safety and efficacy data for our second generation
anti-CD30 antibody encouraging," said Geoffrey M. Nichol, MBChB, Senior Vice
President of Product Development at Medarex. "We are currently enrolling
additional patients at higher dose levels and look forward to examining
further results from the ongoing Phase 1 trial."  

Information about the AACR and its Annual Meeting may be found at
www.aacr.org.

About MDX-1401
MDX-1401 is a second-generation anti-CD30 antibody where fucose (a sugar
structure) is absent, thereby increasing the antibody's antibody-dependent
cellular cytotoxicity, or ADCC, activity (using the Potelligent(R) Technology
of BioWa, Inc.). In preclinical studies, MDX-1401 has shown improved antibody
effector function over a first generation anti-CD30 antibody. The ongoing
Phase 1 trial of MDX-1401 continues to enroll patients with relapsed or
refractory Hodgkin lymphoma to further characterize the clinical profile of
the fully human, non-fucosylated antibody.

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. Over
forty of these therapeutic product candidates derived from Medarex technology
are in human clinical testing or have had INDs submitted for such trials, with
the most advanced product candidates currently in Phase 3 clinical trials, the
subject of regulatory applications for marketing authorization or approved in
Canada and Europe. 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
www.medarex.com.

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 "potential", "expect",
"believe", or "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 the development of MDX-1401, unforeseen safety issues from the
administration of antibody products in humans, as well as risks and
uncertainties 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, 2008 and its
quarterly reports on Form 10-Q. There can be no assurance that 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.

Investor Relations: Laura S. Choi, +1-609-430-2880, x2216, or media: Nichol
Ochsner, +1-609-430-2880, x2214
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