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BiPar Begins Phase 2 Study of Lead PARP Inhibitor in Triple-Negative Breast Cancer Based on Overexpression Biomarker Data
Date:11/15/2007

with the PARP inhibitor BSI-201," said Joyce O'Shaughnessy, M.D., lead investigator, Texas Oncology, PA, Baylor-Sammons Cancer Center in Dallas, US Oncology, and co-chair of the breast cancer research committee of the US Oncology Research Network. "There is a compelling need for a novel approach to treating this high-risk population."

The Phase 2 trial of BSI-201 in patients with triple-negative breast cancer will enroll 120 women in a multicenter, randomized, open-label trial that will compare standard chemotherapy with or without the addition of BSI- 201.

The research presented in Brussels showed the results of an analysis of PARP gene expression in 169 infiltrating ductal breast cancers through the use of the Gene Logic Inc. (Nasdaq: GLGC) BioExpress(R) System database. PARP expression was above the 99.9 percent upper confidence limit for normal tissue in 45 percent of all breast tumors, compared with 75 percent of breast tumors that were estrogen-negative and progesterone-negative and 90 percent of HER2- negative patients.

PARP is a well-characterized and validated target for cancer therapies. PARP plays a central role in cell proliferation in DNA repair, and the PARP-1 gene is upregulated in certain tumor types.

BiPar's novel, proprietary PARP inhibitors are a new generation of drug candidates that show promising activity and a favorable toxicity profile. Preclinical and early clinical studies suggest the drugs selectively induce tumor cell death and are active against a broad range of tumor types. In addition to the trial in patients with triple-negative breast cancer, BiPar plans to begin a series Phase1b and Phase 2 trials of BSI-201 in other major cancers that overexpress PARP over the next
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SOURCE BiPar Sciences, Inc.
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