Medarex, Inc.
(Nasdaq: MEDX) announced 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 medarex.
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.
Medarex, Inc.
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