BSI-201 Demonstrates Significant Tumor Growth Inhibition In Ovarian Cancer Studies

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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."

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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.

About BSI-201

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.

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