Aprea AB

Aprea starts Phase I/II study with APR-246

The MPA approval, on April 8, 2009, for Aprea to start the Phase I/II 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/II, 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.

Figure1: Infusion (i) during day 1-4 and then safety follow-up until day 21. Safety controls as indicated by the yellow markers.

Dosing will be conducted with three patients at each dose level followed by a dose escalation until the highest feasible dose (HFD) is reached. HFD is defined as by Dose Limiting Toxicity or reaching a pre-defined maximum plasma concentration of APR-246.

The primary objective of the study is to define the HFD and the secondary objective is to assess the safety of APR-246. In addition the pharmacokinetic profile of each patient and dose will be documented as well as efficacy variables will be followed.

Since APR-246 is expected to have a mechanism that is favourable for restoring p53 function the patients in this study will be evaluated with respect to their p53 status.

This multi center study will be performed at six of the most experienced University Hospitals in Sweden during 2009 and 2010.

The study is planned to include approximately 20-25 patients and is expected to be reported during 2010.