GoldenBiotech’s New Drug Made Good Progress in the Development of Treating Coronavirus and Clinical Trial of AML( Acute Myeloid Leukemia )
31 Mar., 2020
GoldenBiotech (TW4132), a Taiwan based global pharmaceutical and health supplement company, announced its novel small molecule drug, Antroquinonol (Hocena) had achieved good progress in the development of therapeutic drug for Covid-19(novel coronavirus 2019) and the clinical trial for AML(acute myloid leukemia). Recently, due to the global severe pandemic outbreak of Covid-19 plus lacking approved drugs to use, the USA is in urgent need of testing reagents and therapeutic drugs and accelerating the approval process. GoldenBiotech has begun the application of new Phase 2 clinical trial(IND) through US FDA for treating Covid-19.
Quoted by Dr. Penny Chen, a physician in the Clinical Department of GoldenBiotech that if everything goes well with the Covid-19 trial application with FDA, the patient’s recruiting and the efficacy verification of Antroquinonol can be started very soon in USA. This is the new promising development following the recent being selected for Antroquinonol as one of Top 21 medical and therapeutic drug projects in an emerging solicitated projects globally by MyBioGate, a Houston based biopharma partnership service provider to fight against Covid-19. Antroquinonol was selected at the first round of 21 products out of 300 products covering medical test and treating drugs to provide domestic and overseas investment matching.
As for the clinical trial of AML, Antroquinonol was approved IND by the Ministry of Health (MOH) of the Russian Federation in January 2019 and performed a phase II clinical trial of AML as “Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Acute Myeloid Leukemia (AML) Adult Patients” in Russia.
The trial has recently been completed for all recruited patients and started integrating data. At present, all patients continue to survive.
The clinical trial of Antroquinonol for AML is targeting relapsed patients and is a breakthrough designed treating use by a momotherapy and performed safely and promising results and continuous treatment, compared with the other current standard therapies which use the combination of multiple treatment of chemotherapy drugs causing many side effects and dangers. The given pilot clinical trial of a medicinal product for medical use, is held to evaluate preliminary efficacy and safety/tolerability profiles of antroquinonol in adult patients with relapsed AML or at initial diagnosis when no intensive treatment is possible. This is a IIa open-label, non-randomized clinical trial of Antroquinonol, capsule, 100 mg. The clinical evaluation targets are blood count measurements and survival at 4 and 24 weeks, respectively.
According to Dr. Penny Chen ,” the preliminary results of this trial appeared to be very good. There are several key points remarks:
Firstly, the other studies of AML drugs showed for relapsed patients,regardless what the treatment adopted, the overall median survival (mOS) was six months.
But for AML trial of Antroquinonol, all 11 patients in the trial were alive at 24 weeks after the end of the trial, and continued to survive till now.
Secondly, at the end of 24 weeks of treatment, among the 11 patients,eight people had less than 5% blast cells in their bone marrow.
Thirdly, five of the 11 patients had showed their blast in periferal blood count reducing to zero. “
Acute myeloid leukemia (AML) is a blood cancer. It happens when young abnormal white blood cells called blasts (leukemia cells), begin to fill up the bone marrow , preventing normal blood production. Doctors diagnose AML when 20 out of every 100 white blood cells in the bone marrow is a blast cell .
The data analysis is currently underway, and the actual final results will be announced after the final report is completed.