Golden Biotechnology Corporation (4132.TWO), a Taiwan-based biopharmaceutical company, has revealed that its Antroquinonol, a new drug intended to treat acute myeloid leukaemia (AML) patients, outperformed other listing drugs in its phase two clinical study conducted in Russia, it was reported on Thursday.
The result indicated higher remission rates and survival rates assuring fewer patients will require blood transfusions. The primary efficacy indicator results demonstrated the overall remission rate of patients with relapsed AML reaches 50%. 80% of patients' abnormal blasts counts in bone marrow or blood reduced to less than 5% after treatment. The secondary outcome measures resulted in the overall survival rate of patients with relapsed AML by 100% at the sixth month after the treatment. The trial was an open-label, non-randomised, Phase 2a study to assess efficacy and safety/tolerability profiles in adult patients with relapsed AML or at initial diagnosis when no intensive treatment is possible
The new drug received orphan drug designation from the US FDA for the treatment of AML in 2015.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT