[Asia Economy Reporter Lee Gwan-joo] CrystalGenomics announced on the 13th that it has completed the development of a formulation (G3) that improves the bioavailability (BA, the rate at which a drug enters and is utilized in the body) of the blood cancer treatment drug 'Luxptinib' by 18 times.
According to CrystalGenomics' U.S. partner Aptose, the new G3 formulation, when orally administered as a single dose to 15 patients in an ongoing blood cancer clinical trial, achieved an exposure level with continuous administration of G3 50 mg equivalent to that of 900 mg of the existing formulation (G1).
The company explained that this demonstrates the potential to maximize drug efficacy and reduce side effects by administering much smaller doses in clinical trials targeting blood cancer patients.
Interim pharmacokinetic (PK) data of G3 confirmed approximately a 67-fold increase in blood concentration and about a 200-fold increase in drug exposure compared to the existing formulation (G1).
Aptose plans to submit a revised protocol to the U.S. Food and Drug Administration (FDA) by the end of this month to continue Phase 1 clinical trials with the new formulation for patients with relapsed or refractory acute myeloid leukemia (AML).
Luxptinib is a novel drug candidate that acts as a multi-inhibitor of FLT3 and BTK. Aptose acquired Luxptinib in 2016 for approximately 500 billion KRW. Currently, clinical trials are underway in the U.S. targeting B-cell malignant lymphoma and AML indications.
Williams Rice, CEO of Aptose, said, "The G3 formulation of Luxptinib showed improved BA and greater absorption potential, and we will advance it with continuous dosing in AML trials." He added, "Complete remission (CR) was achieved in one AML patient through the existing G1 formulation, and we hope that the new G3 formulation, which enhances drug penetration effects, will provide therapeutic benefits to patients."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
