PRINCETON, N.J., April 16 /PRNewswire-FirstCall/ -- Medarex, Inc. 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.
CONTACT: Laura S. Choi, Investor Relations, +1-609-430-2880, x2216, or
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Web site: http://www.medarex.com/
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