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news.US-based Galena Biopharma has completed patient enrollment in the GALE-401, or Anagrelide Controlled Release, Phase II clinical trial to treat patients with elevated platelet counts in myeloproliferative neoplasms (MPNs).
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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.