Fennec Pharmaceuticals Inc. said the phase 3 trial of Pedmark met its main goal in reducing cisplatin-induced hearing loss in children being treated for an uncommon form of malignant liver cancer.
The SIOPEL 6 study conducted in 99 patients with standard risk hepatoblastoma showed that the addition of Pedmark to chemotherapy drug cisplatin significantly reduced the incidence of hearing loss without any evidence of tumor protection.
Among the patients treated with the combination of cisplatin and Pedmark, 37% suffered hearing loss, compared with 67% of patients who received cisplatin alone.
The combination also demonstrated an 82.1% event free survival with a 98.2% overall survival, versus 78.8% and 92.3%, respectively, for the chemotherapy alone.
Fennec said it will seek regulatory approval for the drug based on the data from the trial along with proof of principle data from the Clinical Oncology Group Protocol ACCL0431.