PRINCETON, N.J., Jan. 8 /PRNewswire-FirstCall/ -- Medarex, Inc. announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1411 for the treatment of CD70-expressing malignancies, with the initial clinical study to focus on the treatment of clear cell renal cell carcinoma (ccRCC). MDX-1411 was generated by Medarex’s UltiMAb Human Antibody Development System(R).
The open-label, multi-center, dose-escalation, multi-dose Phase I clinical trial is expected to enroll up to 40 patients with advanced ccRCC. The trial is designed to determine the safety, tolerability and maximum tolerated dose of MDX-1411 as well as characterize preliminary efficacy and pharmacokinetics.
“The advancement of this antibody into the clinical trial process adds to our internal pipeline and expands our portfolio of potentially new oncology therapeutics,” said Howard H. Pien, President and CEO of Medarex. “We expect the growth of our pipeline to continue through the addition of proprietary products along with new antibodies that are developed through collaborations.”
About MDX-1411
MDX-1411 is a fully human monoclonal antibody that targets the CD70 receptor, which is a member of the tumor necrosis factor (TNF) family. CD70 is expressed in a number of cancers, including ccRCC primary tumors and metastatic lesions. Preclinical in vitro studies showed that MDX-1411 binds to CD70 positive cells and induces antibody-dependent cellular cytotoxicity (ADCC), an important mechanism of action of therapeutic antibodies that induces the destruction of targeted cells by the immune system. Preclinical in vivo studies conducted in ccRCC xenograft models demonstrated anti-tumor activity.
About Renal Cell Carcinoma (RCC)
According to the American Cancer Society there were almost 39,000 new cases of RCC and 13,000 deaths caused by RCC in 2006. About 80% of RCC cases are clear cell renal cell carcinoma making it the most common among five types of RCC. Renal cell carcinoma generally starts as one or more tumors in one or both kidneys and in advanced stages can spread to other organs. Current treatment options for RCC include surgery, radiation, chemotherapy, immunotherapy and targeted 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. More than 30 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 III 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 Web site 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"; “expect"; “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 MDX-1411 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, 2006 and its 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.
CONTACT: Laura S. Choi, Investor Relations, +1-609-430-2880, x2216, or
Jean Mantuano, Corporate Communications (media), +1-609-430-2880, x2221,
both of Medarex, Inc.
Web site: http://www.medarex.com//
Company News On-Call: http://www.prnewswire.com/comp/108265.html/
