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Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting

M Santegoets, Ph.D., from the Department of Medical Oncology

and Pathology of Vrije Universiteit Medical Center located in

Amsterdam, Netherlands. The data suggested an ipilimumab dose-related

association with increased T-cell activation, as well as associated

anti-tumor activity from the initial 12 patients that was previously

reported at the June 2007 American Society of Clinical Oncology (ASCO)


In the Phase 1 clinical trial, 28 patients with metastatic HRPC have

been enrolled, including 12 patients in the dose-escalation cohort

(0.3, 1, 3 or 5 mg/kg ipilimumab) and 16 patients in the expansion

cohort (3 mg/kg ipilimumab). The dose of GVAX immunotherapy for

prostate cancer used in this combination trial is comparable to that

currently being evaluated in Cell Genesys' ongoing Phase 3 program. The

treatment combination was generally well-tolerated. Adverse events

associated with this regimen are consistent with data previously

reported from this study.

-- "CTLA-4 blockade for hormone refractory prostate cancer: dose-dependent

induction of CD8+ T cell activation and clinical responses" (Abstract


Preliminary data from an ongoing Phase 1 study of escalating doses of

ipilimumab in combination with GM-CSF (sargramostim) were presented by

Lawrence Fong, Ph.D., from the University of California, San Francisco,

San Francisco. Of the six patients treated at 3 mg/kg ipilimumab, three

experienced confirmed decreases in prostate-specific antigen (PSA)

serum levels of over 50%, and one of these patients experienced a

partial response in hepatic metastases.

In the Phase 1 clinical trial, 26 patients with HRPC received treatment

with a 28-day cycle of daily doses of 250 mg/m2 of GM-CSF for 14 days

in combination with

SOURCE Medarex, Inc.
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