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Merck KGaA: Late-stage Trial Of Cilengitide Fails To Meet Primary Endpoint

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2/25/2013 2:14 AM ET

Merck KGaA (MKGAY.PK) announced that the Phase III CENTRICa trial of the investigational integrin inhibitor cilengitide did not meet its primary endpoint of significantly increasing overall survival when added to the current standard chemoradiotherapy regimen or temozolomide and radiotherapy.

CENTRIC includes patients with newly diagnosed glioblastoma and methylated O6-methylguanine-DNA methyltransferase (MGMT) gene promoter status. The trial was planned and is being conducted in partnership with the European Organisation for Research and Treatment of Cancer or EORTC.

The company said that Patient safety in CENTRIC was monitored frequently by an independent data monitoring committee and no new or unexpected safety concerns were noted. In prior clinical studies, the most frequently reported adverse events the investigators considered to be attributed to cilengitide included nausea and fatigue.

CENTRIC is a randomized, controlled, multicenter, open-label Phase III trial. The trial evaluated the efficacy and safety of cilengitide in combination with temozolomide and radiotherapy in more than 500 patients from 23 countries worldwide with newly diagnosed glioblastoma and methylated MGMT gene promoter status. Patients whose tumors have an unmethylated MGMT gene promoter status are currently being evaluated in the Phase II, randomized, open-label, multicenter CORE trial.

According to the company, Cilengitide is the first in a new class of investigational targeted anticancer therapies - the integrin inhibitors - to have reached Phase III clinical development. Cilengitide is thought to target certain integrins over-expressed or aberrantly expressed in many cancers that are involved in tumor cell growth and the formation of new tumor-related blood vessels in the tumor microenvironment.

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by RTT Staff Writer

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