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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
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.
About BiPar Sciences
BiPar Sciences is a drug development company with a therapeutic focus on exploring novel mechanisms of action in oncology. The lead development program is based on DNA repair, specifically with poly ADP-ribose polymerase (PARP) inhibitors. The lead product within that program is BSI-201, a platform drug with the potential to be a superior new treatment across a range of tumor types, both as monotherapy and in combination with chemotherapy. The company is currently testing BSI-201 in a range of Phase 2 trials, including studies in breast, uterine, brain and ovarian cancers.
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