Hanmi Pharm's Acute Myeloid Leukemia New Drug 'HM43239' Confirms Complete Remission in Global Clinical Trial

Hanmi Pharmaceutical.

[Asia Economy Reporter Lee Gwan-joo] Hanmi Pharmaceutical announced on the 8th that a new case of 'complete remission' has been confirmed in the global clinical trial of 'HM43239,' an innovative drug under development for the treatment of acute myeloid leukemia (AML).

HM43239 is a once-daily oral myeloid kinase inhibitor (MKI) targeting key kinases acting in myeloid malignancies. It was licensed out last November to Aptose, a Nasdaq-listed company in the United States. Last month, it was designated as a fast-track development drug by the U.S. Food and Drug Administration (FDA).

According to Hanmi Pharmaceutical, Aptose recently disclosed the latest global Phase 1/2 data for HM43239 in patients with relapsed or refractory AML at a 'Key Opinion Leader (KOL)' webinar and announced that a new complete remission was confirmed even in the expanded dose group of 160 mg.

Complete remission with HM43239 had already been confirmed at doses of 80 mg and 120 mg in ongoing clinical trials. The company explained that this complete remission was also observed in patients who had failed treatment after receiving previously approved FLT3 inhibitors and participated in the clinical trial.

William Rice, Chairman of Aptose, said, “We are pleased to announce new cases of complete remission with HM43239 in relapsed AML patients with wild-type FLT3 and various gene mutations (RAS, BCOR, U2AF1, SETBP1). We have selected three doses and target patient groups for the next expanded clinical phase of HM43239 and will advance toward regulatory approval.”

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