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'First-in-human' drug for malignant glioma available in experimental trial
Date:2/15/2012

CINCINNATI -- The UC Cancer Institute is one of three centers internationally approved to test an experimental drug's safety and pharmacokinetics and also assess the clinical benefit against recurrent malignant glioma, an aggressive form of brain cancer.

The "first-in-human" phase-1 trial is expected to enroll up to 60 patients at clinical sites in the United States and Australia.

Led by Olivier Rixe, MD, PhD, this experimental drug trial uses antibody-drug conjugate (ADC) technology, a new drug delivery concept currently being investigated in the treatment of various cancers. ADC molecules consist of an antibody linked to a specific cytotoxic drug that is intended to target, bind and disperse only in malignant cells.

The experimental drug (called AMG 595) is intended to target a specific mutated cell receptor (EGFRvIII) which exists on the surface of tumor cells in up to 30 percent of patients with malignant gliomas. Preliminary studies in animals have shown that ADC molecules can effectively find these specific cancer cells, then enter them and release an active cytotoxic agent with the aim of killing the tumor cells while minimizing damage to the surrounding normal tissue.

"This allows us to use a highly cytotoxic drug targeted to the cancer cells in the brain based on a specific cellular marker," explains Rixe, John and Gladys Strauss Chair in Cancer Research at the UC College of Medicine and director of the Experimental Therapeutics/Phase 1 Clinical Trials Program. "Until recently, primary brain tumor patients have traditionally been excluded from phase-1 oncology studies, so finding drugs to effectively target and make real advances against this particular type of very aggressive cancer has been virtually impossible."

Patients who have failed first- and second-line therapies for malignant glioma may qualify to participate in this trial. Potential candidates will be screened for the EGFRvIII mutation using t
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Contact: Amanda Harper
amanda.harper@uc.edu
513-558-4657
University of Cincinnati Academic Health Center
Source:Eurekalert

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