Agios Pharmaceuticals Inc (NASDAQ:AGIO) declared the commencement of a Phase 1/2, multi-located, global, open-label investigation funded by Celgene Corporation (NASDAQ:CELG) of AG-221 or AG-120 along with VIDAZA (azacitidine) in people with freshly detected acute myeloid leukemia (AML) having an isocitrate dehydrogenase (IDH) alteration who cannot undergo rigorous chemotherapy. AG-120 and AG-221 are oral, selective, effective suppressors of mutant IDH1 and IDH2 respectively. They are being advanced along with the participation of Celgene.
Study investigator, as well as co-director of the leukemia initiative at City of Hope Cancer Center, Anthony S. Stein, stated that several freshly detected AML patients cannot endure rigorous chemotherapy which restricts their available treatment choices. Seeing the safety and potency showed in clinical investigations of AG-120 and AG-221 in refractory/relapsed AML there is the possibility to give a fresh treatment choice for freshly detected IDH mutant AML patients by including VIDAZA with these therapies.
Chief medical officer of Agios, Chris Bowden said they are quickly executing their strategy for their IDH inhibitors having just started a second investigation in freshly detected AML patients. By administering AG-120 or AG-221 with VIDAZA immediately after detection, the organization hopes to display benefits for individuals with IDH mutant AML, who are ruled out for rigorous chemotherapy.
The trial comprises of a Phase 1b dose-escalation phase as well as a Phase 2.
The investigation will assess AG-221 given at a beginning oral dosage of 100mg one time daily to patients having an IDH2 alteration or AG-120 at a beginning oral dosage of 500 mg once every day in patients having an IDH1 alteration. AG-120 or AG-221 will be given every day in a 28 day period with VIDAZA for seven days of every 28 day period.
The main objective of the Phase 1b stage of the test is to find out the safety as well as endurability and to finalize the suitable Phase 2 dosage of AG-120 or AG-221 along with VIDAZA. The Phase 2 of the trial seeks to find out the potency of VIDAZA alone as well as in combination with AG-120 or AG-221.