PRINCETON, N.J., Jan. 3 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced that it received a milestone payment from its licensing partner, ImClone Systems Incorporated, following the acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for IMC-3G3, a fully human antibody that targets platelet-derived growth factor receptor alpha (PDGFRa) for the treatment of cancer. The antibody product was developed using Medarex’s UltiMAb(R) technology and is the second UltiMAb-derived antibody in clinical development by ImClone Systems. Medarex may receive future milestone payments and royalties should this product candidate progress through clinical development and to the market.
The Phase I clinical trial is currently underway and is designed to establish and evaluate the safety profile, pharmacokinetics and pharmacodynamics of IMC-3G3 administered weekly by intravenous infusion. The study is expected to enroll 30 to 40 patients with solid tumors at two clinical sites in the United States. According to ImClone Systems, data from preclinical animal models indicate that binding PDGFRa with IMC-3G3 results in reduction of cancer cell proliferation and tumor growth.
“We are pleased with the steady progress our partner, ImClone Systems, continues to make with Medarex’s UltiMAb technology,” said Irwin Lerner, Chairman of the Board of Directors and Interim President and CEO of Medarex. “We believe that this clinical development milestone is another demonstration of the broad applicability and appeal of our antibody technology for generating and developing potentially important new therapeutics.”
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. With this announcement, thirty-five of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with six of the most advanced product candidates currently in Phase III clinical trials. 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 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;" “believe;" “anticipate;" “intend;" “plan;" “expect;" “estimate;" “could;" “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 discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of antibody products in patients, uncertainties related to product manufacturing 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, 2005 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such 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.
Medarex, Inc.
CONTACT: Laura S. Choi, Investor Relations, +1-609-430-2880, x2216, orJean Mantuano, Corporate Communications (media), +1-609-430-2880, x2221,both of Medarex, Inc.
Web site: http://www.medarex.com/
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