U.S. Oncology Initiates Complete Phase Ib Trial of Brostallicin Combination Therapy in Advanced So... (F.A.C.P. Physician-in-Chiefand Director ...)

U.S. Oncology Initiates Complete Phase Ib Trial of Brostallicin Combination Therapy in Advanced Solid Tumors

Date:10/18/2007

F.A.C.P., Physician-in-Chief and Director of the Clinical Translational Research Division at the Translational Genomics Research Institute (TGen), Chief Scientific Officer of U.S. Oncology. "With its extensive patient screening at multiple sites, U.S. Oncology is uniquely suited to conduct such studies with a single protocol and parallel multiple regimens."

"Extensive preclinical studies demonstrated that brostallicin is synergistic with multiple agents including both bevacizumab and irinotecan," said James A. Bianco, President and CEO of CTI. "This trial is designed to rapidly follow-up that preclinical data in one consolidated phase I study, save time and expense normally associated with the start up of multiple trials, accrue eligible patients rapidly and generate data to better inform the design of future randomized phase II or III trials."

About Brostallicin

Brostallicin, a novel synthetic second-generation DNA minor groove binder, has potent cancer killing activity and has demonstrated synergism in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical experimental tumors models. Brostallicin binds covalently to DNA within the DNA minor groove interfering with DNA division and leading to tumor cell death. More than 200 patients have been treated with brostallicin in single-agent and combination studies. Brostallicin had predictable and predominantly hematologic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma met its pre-defined activity and safety hurdles and resulted in a first-line phase II study that is currently being conducted by the European Organization for Research and Treatment of Cancer (EORTC).

Brostallicin was discovered at Pharmacia and developed by Nerviano Medical Sciences (NMS) the largest pharmaceutical research and development facility in Italy and one of the largest oncology-
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