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US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201
Date:7/20/2009

work and hope that this trial will lead to rapid FDA approval of what appears so far to be a well tolerated and effective therapy."

BSI-201 targets PARP, or poly (ADP-ribose) polymerase, a key enzyme involved in DNA repair and cell proliferation. By inhibiting the enzymatic activity of PARP, BSI-201 significantly enhances the anti-tumor effects of chemotherapy and has shown promising safety and efficacy results in patients with solid tumors.

"We are extremely pleased to be launching the Phase 3 clinical trial so rapidly after the close of the Phase 2 trial," said Barry Sherman, M.D., head of clinical development at South San Francisco-based BiPar Sciences, which is developing BSI-201. BiPar is a wholly owned subsidiary of Paris-based sanofi-aventis. "Our primary focus now is enrolling patients in this trial with a similar sense of urgency."

Physicians within the US Oncology network are expected to enroll more than 100 participants in this 420-patient study. Enrollment in the study opened July 16 in centers nationwide.

"The BSI-201 PARP Inhibitor is a potential game changing therapy in the treatment of triple-negative breast cancer. US Oncology Research is excited about the opportunity to continue our development collaboration with BiPar on this important potential new therapy," said Steve Smith, vice president and general manager of Research and Personalized Science for US Oncology Research. "We are eager to leverage the US Oncology Research network to support the study."

Patients targeted for the study include adults with histologically documented breast cancer that is ER-negative, PR-negative, and HER2- non-overexpressing after treatment with gemcitabine/carboplatin with or without BSI-201. Patients must have measurable metastatic breast cancer with zero to two prior chemotherapy regimens for metastatic disease; adjuvant chemotherapy is allowed. Patients i
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SOURCE US Oncology, Inc.
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