Pharmaceutical Business review

Galena Biopharma closes enrollment in Phase II trial of GALE-401

The MPNs include essential thrombocythemia (ET), polycythemia vera (PV) and primary myelofibrosis (PMF).

A total of 18 patients have been enrolled in this open-label, single-arm, multicenter Phase II trial, which is designed to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to assess safety and tolerability, as well as to measure plasma concentrations of anagrelide.

Galena president and chief executive officer Mark Schwartz said: "Completing enrollment approximately six months ahead of schedule in the GALE-401 Phase II trial will allow us to present key data in 2015.

"Once we assess the results of this clinical proof-of-concept trial, we will determine the best path forward for the compound."

According to the company, the platelet lowering ability of GALE-401 will be measured by the proportion of patients that achieve a complete or partial platelet response for at least four weeks during 24 weeks of treatment.

The enrolled patients will now be followed for platelet response while they continue trial treatment.