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news.BiPar Sciences has announced promising results from first-in-human clinical studies of its lead product, BSI-201, in patients with solid tumors.
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The Phase I monotherapy trial and the Phase Ib combination therapy trial demonstrated an excellent safety profile and initial indications of clinical benefit were observed.
BSI-201 demonstrated an excellent safety profile and evidence of clinical benefit in 65% (59 of 90) patients in the combined Phase I/Ib study populations, consisting of heavily pre-treated patients with advanced solid tumors. Furthermore, significant (> 80% relative to baseline) and prolonged (> four days duration) PARP inhibition in blood cells was observed after multiple doses of BSI-201.
Hoyoung Huh, president and CEO of BiPar, said: “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.”