Date: 2016-12-28
Type of information: Submission of a clinical trial application
phase: 3
Announcement: submission of a clinical trial application
Company: Galena Biopharma (USA - OR)
Product: GALE-401 (anagrelide controlled release )
Action
mechanism: phospholipase A2 inhibitor/platelet aggregation inhibitor. Anagrelide slows down how fast platelets are made in the bone marrow, and has been approved by the FDA for treating high platelets counts in patients with bone marrow disorders. GALE-401 is a new preparation of anagrelide that is made to dissolve more slowly than currently marketed versions of this drug. Because of this, the anagrelide is taken up into the blood more slowly. This slower release of the drug could help to lower side effects that might be caused by high blood levels when the drug dissolves as quickly as it does with the currently marketed product.
Disease: essential thrombocythemia
Therapeutic area:
Country:
Trial details:
Latest
news: * On December 28, 2016, Galena Biopharma announced the Company has confirmed the regulatory pathway to advance GALE-401 (Anagrelide Controlled Release) into a pivotal, Phase 3 trial. After a productive meeting with the FDA, the Company has confirmed the development program and proposed clinical trial are appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway.
The Phase 3 clinical trial will enroll patients with essential thrombocythemia who have either failed or are intolerant to hydroxyurea, and will compare GALE-401 to the best available therapy (BAT) that will include a sizable subpopulation of patients treated with anagrelide immediate release. The Company expects to finalize the Phase 3 clinical trial protocol and initiate the trial in Q2, 2017.
