BSI-201 Demonstrates Significant Tumor Growth Inhibition In Ovarian Cancer Studies
BiPar Sciences announced positive preclinical data demonstrating the activity of its lead poly ADP-ribose polymerase (PARP) inhibitor, BSI-201, in ovarian cancer models. The results highlight the anti-tumor activity of BSI-201 through PARP activity inhibition, tumor growth suppression, and extended survival in multi-drug resistant xenograft models of ovarian cancer.
"We are excited to share emerging data on the therapeutic potential of BSI-201 as a novel oncology platform drug, in the area of DNA repair inhibition," said Hoyoung Huh, M.D., Ph.D., President and CEO of BiPar Sciences. "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."
The data presented at the 2008 American Association for Cancer Research (AACR) Annual Meeting today, 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 1 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 2 monotherapy trial in BRCA-negative ovarian cancer patients. These ovarian cancer trials represent an important expansion of BiPar's on-going Phase 2 programs in breast and brain cancer patients.
BSI-201, a novel DNA repair inhibitor of PARP, is BiPar's lead product candidate. BSI-201 is a small molecule candidate with the potential of becoming a superior, new class of treatment that possesses in-vivo activity across a broad range of tumor types, both as monotherapy and in combination with standard-of-care chemotherapy regimens. In addition, Phase 1 studies of BSI-201 have demonstrated that the drug is well-tolerated with minimal adverse side effects. BSI-201 is currently in Phase 2 clinical trials in multiple solid tumor settings, including breast, ovarian, brain and uterine cancers.