Aptose Announces FDA Allowance of Investigational New Drug Application for CG-806

- March 25th, 2019

Aptose Biosciences (NASDAQ:APTO,TSX:APS) has announced that the US Food and Drug Administration (FDA) has completed its review of Aptose Bioscience’s investigational new drug submission for CG-806. As quoted in the press release: Aptose has been granted IND allowance to initiate its Phase 1 clinical trial, which is a Phase 1, multicenter, open label, dose-escalation study … Continued

Aptose Biosciences (NASDAQ:APTO,TSX:APS) has announced that the US Food and Drug Administration (FDA) has completed its review of Aptose Bioscience’s investigational new drug submission for CG-806.

As quoted in the press release:

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 (CLL/SLL) or non-Hodgkin lymphomas (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 the 2nd quarter of 2019. Pending collection and careful 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 (AML) and myelodysplastic syndromes (MDS) in a separate Phase 1 trial.

“We are pleased that the FDA has allowed Aptose to perform clinical trials with CG-806, our first-in-class pan-FLT3/pan-BTK inhibitor,” said William Rice, Ph.D., Chairman, President & CEO. “CG-806 has demonstrated a favorable safety profile and compelling durable tumor elimination in animal models of cancer, and we look forward to advancing it into human clinical testing.”

Click here to read the full press release.

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