Galena completes patient enrolment in Phase II GALE-401 trial

19th November 2014 (Last Updated November 19th, 2014 18:30)

Galena Biopharma has completed patient enrolment in the GALE-401, or Anagrelide Controlled Release, Phase II clinical trial to treat patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET), polycythemia vera (PV) and primary myelofibrosis (PMF).

Galena Biopharma has completed patient enrolment in the GALE-401, or Anagrelide Controlled Release, Phase II clinical trial to treat patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET), polycythemia vera (PV) and primary myelofibrosis (PMF).

The company has enrolled a total of 18 patients in this open-label, single-arm, multicentre Phase II trial.

The trial is designed to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to evaluate safety and tolerability, as well as to measure plasma concentrations of anagrelide.

The company said that 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 trial is designed to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to evaluate safety and tolerability, as well as to measure plasma concentrations of anagrelide."

These enrolled patients will now be followed for platelet response while they continue study treatment.

Galena president and chief executive officer Mark Schwartz said: "Completing enrolment 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.

"I am proud of the work done by our team, and grateful for our investigators and patients who supported this trial, some of whom switched from their current therapy to participate."

GALE-401, the company's new formulation of anagrelide, releases the active ingredient more slowly over time than currently marketed versions of this drug, and is therefore absorbed more slowly into the bloodstream.

According to the company, slower release of the drug could help in reducing adverse events that might be caused by high blood concentrations when the drug is absorbed rapidly, as it is with currently marketed products.

Based on discussions with the FDA and pending a successful development programme, the company would pursue approval through the 505(b) (2) regulatory pathway.