The Phase 1 monotherapy trial and the Phase 1b combination therapy trial demonstrated an excellent safety profile and initial indications of clinical benefit were observed. These data were presented today at the 44th American Society of Clinical Oncology annual meeting in Chicago.

BSI-201 demonstrated an excellent safety profile and evidence of clinical benefit in 65% (59 of 90) patients in the combined Phase 1/1b study populations, consisting of heavily pre-treated patients with advanced solid tumors. Furthermore, significant (> 80% relative to baseline) and prolonged (> 4 days duration) PARP inhibition in blood cells was observed after multiple doses of BSI-201.

"These clinical results show that BSI-201 can be administered safely, both alone and in combination with other chemotherapeutic agents, across a broad range of tumors. Moreover, we are extremely encouraged that the synergistic effects of a PARP inhibitor, in combination with other standard-of-care chemotherapeutic treatments, are supported by these clinical observations," said Hoyoung Huh, M.D., Ph.D., President and Chief Executive Officer of BiPar. "In the last year, we have moved BSI-201 into a comprehensive Phase 2 program, focusing on breast, brain, uterine and ovarian cancers, providing the clinical platform for BiPar Sciences to establish PARP inhibition as a novel and effective therapeutic approach in oncology."

Active BSI-201 Phase 2 Program in Solid Tumors

The company is currently conducting a randomized Phase 2 trial of BSI-201 in triple-negative breast cancer and is collaborating with the New Approaches to Brain Tumor Therapy (NABTT) consortium, a National Cancer Institute-funded research group, to test BSI-201 in glioblastoma multiforme (GBM), the most common brain cancer in adults. BSI-201 is also being evaluated by Memorial Sloan-Kettering Cancer Center investigators as a monotherapy for patients whose ovarian cancer is linked to a hereditary BRCA genetic defect. Finally, the company is working with the NCI-sponsored research group, the Gynecologic Oncology Group, to test BSI-201 in patients with advanced, persistent or recurrent uterine cancer. The Phase 2 program has been guided by gene expression data demonstrating PARP up-regulation in targeted tumor classes.

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