Monday, February 22, 2010

Aprea starts Phase I study with APR-246

A patient who did not respond to treatment has entered the following clinical trial, I thought it might be of interest and have posted the link.

Aprea starts Phase I study with APR-246

The MPA approval, on April 8, 2009, for Aprea to start the Phase I study meant that the company could go ahead and start the study with their first CD (APR-246, also denoted PRIMA-1MET in the literature). Patients started to be included in June 2009.

This study, APR-246-01, is a first-in-man, multi-center, open label, non-comparative, phase I, dose escalating study of APR-246 infusions in patients with refractory hematologic malignancies or prostate carcinoma.

During the treatment phase, the patient will receive APR-246 treatment on four consecutive days as a 2-hour daily intravenous infusion. The treatment phase will be followed by a 17 days follow-up phase to reveal any late adverse effects. The patient’s total duration in the study will be 21 days.