Aptose Biosciences announces FDA allowance of CG-806 IND
Aptose Biosciences announced that the FDA completed their review of the company's investigational new drug, or IND, submission for CG-806. Aptose has been granted IND allowance to initiate its Phase 1 clinical trial, which is a Phase 1, multicenter, open label, dose-escalation study with expansions to assess the safety, tolerability, PK and preliminary efficacy of CG-806 in patients with chronic lymphocytic leukemia, or CLL/SLL, or non-Hodgkin lymphomas, or NHL. Aptose will conduct a Phase 1 trial with orally administered CG-806 in patients with relapsed or refractory B cell malignancies, including CLL/SLL and NHL who have failed or are intolerant to standard therapies. The Phase 1 trial is expected to initiate in Q2. Pending collection and review of the initial safety data and predictive pharmacokinetic data in humans from this trial, Aptose plans to seek allowance from the FDA to move into patient populations that include relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes in a separate Phase 1 trial.