Phase III trial of Tookad (padeliporfin di-potassium) meets endpoint in prostate cancer and receives approval in Mexico-Steba Biotech

Steba Biotech has announced positive top-line results from PCM304, its Latin American Phase III clinical trial of Tookad (padeliporfin di-potassium), a novel investigational treatment for localized prostate cancer and other solid tumors. Analyses of the results showed that the primary endpoint has been met, demonstrating that Tookad increased the rate of cancer-free patients at 12 months. Quality of life parameters (urinary and erectile functions) and safety are consistent with previous Tookad clinical studies.

Based on these positive results, Steba Biotech has submitted marketing authorization application for Tookad to the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the Mexican health authority. After review, the COFEPRIS has granted the first marketing authorization for Tookad for the treatment of low-risk localized prostate cancer patients on November 12, 2015.