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Medarex Announces Ipilimumab Program Continues to Move Forward
Date:4/3/2008

24 Phase 3 trial by the Data Monitoring Committee (DMC) indicated that our trial should continue.

Finally, we and our partner, Bristol-Myers Squibb Company, continue to move firmly forward. Our previously-stated guidance remains unchanged and regulatory discussions are pending."

About the Chemotherapy Combination Registrational Trial

Study 024 is a randomized, blinded registrational Phase 3 study designed to evaluate the effect of dacarbazine in combination with 10mg/kg ipilimumab or placebo on progression-free survival and overall survival in 500 patients with previously untreated metastatic melanoma (front-line). Ipilimumab is administered at 10 mg/kg 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 or placebo will be administered once every 12 weeks until disease progression. All efficacy analyses, except for overall survival and survival rate at one year, will be conducted when at least 416 events for progression- free survival have been observed in the study and all patients have been followed for at least 12 weeks.

In June 2006, the 024 registrational Phase 3 trial was reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) concerning the suitability of the trial design to support regulatory approval. In December 2006, the FDA granted Fast Track status to this program which provides for expedited regulatory review for new drugs that demonstrate the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. Trial enrollment was completed in the first- quarter of 2008.

About Ipilimumab

Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. The absen
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SOURCE Medarex, Inc.
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