BiPar Sciences, Inc. has announced the results of first-in-human clinical studies of its lead product, BSI-201, in patients with solid tumors.
The Phase 1 monotherapy trial and the Phase 1b combination therapy trial demonstrated safety profile and initial indications of clinical benefit were observed. These data were presented at the 44th American Society of Clinical Oncology annual meeting in Chicago.
BSI-201 demonstrated 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."