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Interim Phase 1/2 Data of Ipilimumab in Prostate Cancer Presented at American Society of Clinical Oncology Annual Meeting
Date:6/2/2008

ion resistant prostate cancer and bone metastases, and these data encourage further exploration of the ability of tumor antigen release by radiotherapy to serve as an immune-supportive intervention in combination with ipilimumab as a potentially important treatment option for these patients."

The Phase 1/2 trial was conducted to evaluate the safety and preliminary anti-tumor activity of escalating doses of ipilimumab (3, 5 or 10 mg/kg) every three weeks for up to four doses, with and without a single dose of focal radiotherapy administered to target bone lesion(s) prior to the first dose of ipilimumab. The dose escalation portion of the trial enrolled 33 patients with mCRPC and with bone metastases. Additional patients are enrolling in the expansion cohort of 10mg/kg ipilimumab in combination with radiotherapy.

Adverse events related to ipilimumab in this study were generally manageable and consistent with those immune-related adverse events (irAEs) previously reported in other clinical trials of ipilimumab. Grade 3/4 adverse events included diarrhea/colitis (5 patients), rash (1 patient) and elevated liver enzymes (2 patients). No new patterns or frequency of adverse events emerged in patients receiving the combination of ipilimumab and radiotherapy.

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 absence or presence of CTLA- 4 can augment or suppress the immune system's T-cell response in fighting disease. Ipilimumab is designed to block the activity of CTLA-4, thereby sustaining an active immune response in its attack on cancer cells.

Comprehensive Clinical Trial Program for Ipilimumab

Bristol-Myers Squibb Company and Medarex remain committed to the development of ipilimumab. The companies also have ongoing Phase 2 studies in hormone-refractory prostate canc
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SOURCE Medarex, Inc.
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