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Early results show encouragement in treatment of glioblastoma brain tumors.

Posted on: 12/20/2004

Early results show encouragement in treatment of glioblastoma brain tumors.

Angiogenesis Weekly, Dec 24, 2004 p18

Full Text: COPYRIGHT 2004 NewsRX

2004 DEC 24 - ( & -- Merck, KGaA, of Darmstadt, Germany, announced that it is encouraged by the results of a U.S. National Cancer Institute (NCI)-sponsored phase I study of the angiogenesis inhibitor cilengitide in the treatment of glioma, an aggressive form of brain tumor.

The results support Merck's continuing clinical development of the compound for which a phase II study in recurrent glioblastoma multiforme was initiated in October.

Data presented at the ninth annual meeting of the Society for Neuro- Oncology in Toronto, Ontario show that out of 51 patients enrolled in the multicenter, dose-escalation study designed to determine the maximum tolerated dose of cilengitide in patients with glioma, 2 patients showed complete response, 3 patients exhibited partial response, and 4 patients had stable disease for more than 6 months.

"These data, although from an early study in a small number of patients, are encouraging in the treatment of an aggressive, malignant tumor type for which there are few options," said L. Burt Nabors, MD, associate professor at the University of Alabama- Birmingham and lead investigator of the trial. "Certainly, these data warrant further study and support the initiation of a phase II trial."

A randomized, phase II trial of cilengitide was initiated by Merck, KGaA, in October 2004 in patients with recurrent glioblastoma multiforme who are receiving cilengitide after first-line chemotherapy failed. The phase II exploratory study is intended to confirm the findings from the phase I study and provide proof of concept. The study is being conducted by EMD Pharmaceuticals, Inc., a U.S. subsidiary of Merck, KGaA.

In addition to the Merck, KGaA-initiated study, the NCI is sponsoring a number of clinical trials under a cooperative research and development agreement with Merck, KGaA, for the development of cilengitide. One phase II trial (NABTT 0306) combines cilengitide with radiation therapy and temozolomide in patients newly diagnosed with glioblastoma multiforme. A second phase II trial (NABTC 0302) is planned to study cilengitide in the treatment of patients with recurrent glioblastoma multiforme who require a resection.

This article was prepared by Angiogenesis Weekly editors from staff and other reports. Copyright 2004, Angiogenesis Weekly via &

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