Keryx has initiated phase 1 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for recurrent solid tumors in pediatric patients.
KRX-0401 is an oral, anticancer agent that modulates Akt and several other important signal transduction pathways.
The company is now in the process of finalizing late-stage protocols for Perifosine, in the treatment of multiple myeloma and metastatic colon cancer.
In the phase 1 study, perifosine is being evaluated as a single-agent in pediatric patients with any solid tumor that has failed standard therapy. Patients up to 18 years of age with a performance status of greater than 40%, are eligible for this study. The study has been designed as a dose escalation study to determine the maximum tolerated dose (MTD) of perifosine alone in recurrent/progressive pediatric tumors.
Ron Bentsur, CEO of Keryx, said: We’re very excited that Memorial-Sloan Kettering has taken on a leadership role in the first pediatric study of perifosine. We are extremely grateful for the external financial support which we have received, and we look forward to working with Drs. Becher and Holland, and their team of renowned oncologists on this study.