Medarex reports MDX-010 trial results following stock offering

By Lisa Kerner

Erie, Pa., April 6 - Medarex, in a move related to its public offering of common stock on Monday, is providing details of an open-label, dose-escalation clinical trial of patients with advanced melanoma reported by NCI investigators at the iSBTc Conference in November 2005.

Doses of ipilimumab (MDX-010) were escalated from 3.0 mg/kg, or in some patients 5mg/kg, up to 9.0 mg/kg with each patient receiving a dose once every three weeks until the development of tumor shrinkage or a dose-limiting inflammatory event.

According to a company release, of 80 patients, 65 patients received ipilimumab as monotherapy and the remainder received ipilimumab in combination with MDX-1379, a gp100 melanoma peptide vaccine. Eight of the 65 (12%) patients treated with monotherapy experienced clinical responses, while six of the 15 (40%) patients receiving ipilimumab in combination with MDX-1379 experienced clinical responses.

In a separate open-label pharmacokinetic and safety study of 24 patients (23 with advanced melanoma and one determined to have lung cancer), two patients experienced clinical responses.

Patients in this study received a dose of 10.0 mg/kg of ipilimumab as monotherapy once every three weeks for four doses. Nine of the 24 patients were progression-free at the first tumor assessment at 12 weeks.

Combined data from the two studies indicate an overall clinical response rate of about 11%, the company said.

The most common inflammatory event reported was grade ¾ colitis.

Medarex is a biopharmaceutical company based on Princeton, N.J., focused on the discovery and development of fully human antibody-based therapeutics

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