Foresee's prostate cancer candidate hits Phase III goals

Taiwan-based Foresee Pharmaceuticals (6576.TWO) today announced top-line results of FP-001 LMIS (leuprolide mesylate injectable suspension) 2mg Phase III clinical trial, an open-label, single-arm study in subjects with prostate carcinoma, which met its primary efficacy endpoint in 97.9% of subjects.

The primary efficacy end point is the percentage of subjects with suppression of serum testosterone (≤ 50ng/dl) by day 28 and from day 28 to day 168 in the intent-to-treat (ITT) population. The targeted efficacy end point was that the lower limit of the 2-sided 95% confidence interval (CI) for suppression to be >90%.

Earlier this month, Foresee entered into a licensing deal for certain territories with Accord Healthcare, a UK-based subsidiary of Indian biopharma company Intas Pharmaceuticals, for FP-001 LMIS, which could be worth as much as $86 million to the Taiwanese firm.