The data evaluated BSI-201 as both a single agent and in combination with topotecan in human OVCAR-3 xenografts resistant to adriamycin, melphalan and cisplatin. Administered as monotherapy, BSI-201 demonstrated significant tumor growth delay and improved survival. In combination with topotecan, BSI-201 significantly inhibited tumor growth and increased the percentage of complete tumor regressions, compared with topotecan alone.
Based on the preclinical findings and positive Phase I results, BiPar is currently enrolling in a clinical trial of BSI-201 in combination with topotecan in advanced ovarian cancer and will soon launch a Phase II monotherapy trial in BRCA-negative ovarian cancer patients. These ovarian cancer trials are said to represent an important expansion of BiPar’s on-going Phase II programs in breast and brain cancer patients.
Hoyoung Huh, president and CEO of BiPar, said: “BSI-201 represents an innovative therapeutic candidate which is well positioned as both monotherapy and combination treatment in multiple solid tumor settings including ovarian cancer.”