Aptose Biosciences gains after FDA greenlights Phase 1 trial for blood cancer drug CG-806

Shares of Aptose Biosciences Inc (NASDAQ:APTO) (TSE:APS) rose in Monday’s pre-market session after the US Food and Drug Administration gave the go-ahead for the clinical-stage biotech to kick off a Phase 1 clinical trial to evaluate its drug CG-806 for the treatment of chronic lymphocytic leukemia or non-Hodgkin lymphomas.

Aptose is now set to start its Phase 1 trial of CG-806 in the second quarter of this year for patients with relapsed or refractory chronic lymphocytic leukemia and non-Hodgkin lymphomas who have failed to respond to standard therapies.

READ: Aptose Biosciences reaches China distribution deal for CG-806 with South Korea’s CrystalGenomics

In response, Aptose shares jumped 3.5% to $2.40 before the opening bell Monday.

“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 Dr. William Rice, Aptose’s 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.”

After reviewing the initial data from this trial, Aptose plans to broaden its program to include patients with relapsed or refractory acute myeloid leukemia as well as myelodysplastic syndromes in a separate Phase 1 trial.

CG-806 is a small molecule that is being developed for the treatment of acute myeloid leukemia, B-cell malignancies and additional blood cancers.

Headquartered in San Diego, California and Toronto, Canada, Aptose is a clinical-stage biotech company specializing in oncology, but with a focus on hematology.

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors