Medarex, Inc. Announces Special Protocol Assessment Agreement With The FDA To Initiate Registrational Trial For Ipilimumab (MDX-010) Combination With Chemotherapy In First-Line Metastatic Melanoma Patients
PRINCETON, N.J., June 19 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced the receipt of a Special Protocol Assessment (SPA) letter from the U.S. Food and Drug Administration (FDA) for the initiation of a registrational clinical trial of ipilimumab (also known as MDX-010) used in combination with chemotherapy in previously untreated (first-line) metastatic melanoma patients. The SPA agreement with the FDA concerns the suitability of the trial design to support regulatory approval.
The randomized, double-blind, two-arm registrational clinical trial is expected to commence shortly. The trial is expected to enroll approximately 500 patients with previously untreated Stage III or Stage IV metastatic melanoma. Patients will receive ipilimumab (10 mg/kg) in combination with dacarbazine, or dacarbazine alone once every three weeks for up to four doses. Subsequently, eligible patients who have not experienced disease progression at week 24 will continue in a maintenance phase where a single dose of ipilimumab will be administered once every 12 weeks until disease progression. The study is designed to assess progression-free survival as the primary endpoint. Secondary endpoints include overall survival, progression-free survival rate at week 12, best overall objective response rate and duration of responses, and disease control rate (complete and partial responses plus stable disease).
"We believe that the combination of ipilimumab and chemotherapy may provide a potentially important treatment for metastatic melanoma, an area where new therapies are urgently needed," said Donald L. Drakeman, President and CEO of Medarex.
For study enrollment information, in the United States and Canada contact 1-866-892-1BMS Ext. 342 or go to www.clinicaltrials.gov. Outside of the United States and Canada, call 1-941-906-4711 Ext. 342.
About ipilimumab
Ipilimumab (also known as MDX-010) is a fully human antibody against human CTLA-4, a molecule on T cells that is believed to be responsible for suppressing the immune response. Medarex and Bristol-Myers Squibb are investigating the potential of ipilimumab to enable the immune systems of cancer patients to help suppress or eradicate the tumor. In addition to the first-line dacarbazine combination registrational study, ipilimumab is currently under investigation in two registrational trials as second-line therapy for metastatic melanoma under two separate Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). One is a recently initiated monotherapy study that is expected to be completed this year, and the other is in combination with MDX-1379 (a melanoma peptide vaccine). Ipilimumab is also being evaluated in multiple Phase II clinical trials to investigate the product's potential activity in other tumor types, as well as in combination studies with chemotherapy, immunotherapy and vaccines. Further information regarding Medarex's ipilimumab program can be found in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC).
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. Thirty-two of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with five 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.
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Medarex, Inc.CONTACT: Laura S. Choi, Investor Relations, x2216, or Jean Mantuano,Corporate Communications - media, x2221, both of Medarex, Inc.,+1-609-430-2880
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