Medarex Reports Phase 1/2 Clinical Data of MDX-060 in Lymphoma at American Association for Cancer Research Meeting
PRINCETON, N.J., April 16 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX)
announced today data from a Phase 1/2 trial that suggest a potential association
between higher doses of MDX-060, an investigational anti-CD30 antibody, and
improvement in disease control and prolonged progression-free survival in patients
with relapsed or refractory CD30- positive lymphomas. Results from the Phase 1/2
trial were presented at the Annual Meeting of the American Association for Cancer
Research (AACR), being held April 12-16, 2008 in San Diego (Abstract #5525).
"We continue to assess the potential for anti-CD30 antibody therapies in the
marketplace and are pleased with the findings of this exploratory study," said
Howard H. Pien, President and CEO of Medarex. "We look forward to analyzing these
results alongside the Phase 2 proof-of-concept chemotherapy combination data that is
expected later in the year."
In the completed dose-escalation Phase 1/2 trial, 72 patients with relapsed or
refractory CD30-positive lymphoma received weekly doses of MDX-060 (0.1, 1, 4, 10 or
15 mg/kg) for four weeks. Of the 33 patients treated at the two highest doses of
MDX-060, disease control was observed in 51 percent of patients (3 complete
responses, 14 stable disease), with median progression- free survival of 3.7 months
and 39 percent of patients with no evidence of disease progression four months
post-treatment. Of the 39 patients treated at the three lowest doses of MDX-060,
disease control was observed in 33 percent of patients (1 complete response, 2
partial responses, 10 stable disease), with median progression-free survival of less
than 2 months and 18 percent of patients with no evidence of disease progression
four months post-treatment. MDX-060 treatment was well-tolerated with no clinically
meaningful infusion reactions. The most frequently reported drug-related adverse
events were fatigue and pyrexia considered to be mild to moderate in severity.
About Anti-CD30 Antibody Therapy
MDX-060 is a fully human antibody that targets CD30, a marker found on activated
lymphocytes that is present on malignant cells of Hodgkin's disease (HD) as well as
other CD30-expressing cancers. Medarex is currently conducting an ongoing Phase 2
proof-of-concept trial of MDX-060 in combination with gemcitabine for HD. Medarex is
also developing MDX-1401, a second-generation non-fucosylated version of the MDX-060
parental antibody, that is enhanced for greater antibody-dependent cellular
cytotoxicity and is being explored in a multi-dose, dose-escalation Phase 1 clinical
trial for HD.
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
www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters discussed herein
relating to Phase 1/2 clinical data of MDX-060 in lymphoma 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"; "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
development, unforeseen safety issues resulting from the administration of antibody
products in humans, 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, 2007 and its
quarterly reports on Form 10-Q. There can be no assurance that future milestone
payments will be paid, whether the product development efforts will succeed, or
whether 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.
-0- 04/16/2008
/CONTACT: Laura S. Choi, Investor Relations, +1-609-430-2880, x2216, or Nichol
Harber, Corporate Communications (media), +1-609-430-2880, x2214, or Jean Mantuano,
Corporate Communications (media), +1-609-430-2880, x2221/
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/Web site: http://www.medarex.com /
(MEDX)
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