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.
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.
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.|
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