Breakthrough in AML Treatment: GoldenBiotech reports new drug trial of Antroquinonol

▴ Breakthrough in AML Treatment: GoldenBiotech reports new drug trial of Antroquinonol
Outperforms listing drugs in relapsed Acute Myeloid Leukemia

Golden Biotechnology Corp.(GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company, announces that its new drug Antroquinonol (HOCENA) outperforms the other listing drugs for the treatment of relapsed AML (acute myeloid leukemia) patients in its Phase 2 clinical study conducted in Russia. The outcome measures demonstrated higher remission rates (50%, CR/Cri) and survival rates guaranteeing fewer patients will require blood transfusions. This has made high safety possible during breakthroughs for AML treatment with remarkable monotherapy without combined chemotherapy. The new drug Antroquinonol has been granted orphan drug designation (ODD) by the U.S. FDA for the treatment of AML in 2015. GoldenBiotech has achieved excellent breakthrough in the unmet medical needs in AML therapy which many global pharmaceutical companies are targeting.

Clinical Results Summary:

*Primary Outcome Measure- overall remission rate (CR/CRi): 50%

*Secondary Outcome Measures

     80% of patients showed that their blasts count were less than 5%      90% of patients did not need blood transfusion during trial period      100% of patients were all alive during trial period (6 months)      No serious side effect

The primary efficacy indicator results exhibit that the overall remission rate (CR/CRi) of patients with relapsed acute myeloid leukemia reaches 50%. This is higher than those of other listing drugs in their Phase 2 trial ranging approximately from 21%~33% in (CR/CRi). 80% of patients' abnormal blasts counts in bone marrow or blood were decreased to be less than 5% after treatment. For the secondary outcome measures results the overall survival rate of patients with relapsed AML reached 100% by the 6th month after treatment. This amplifies the possibility of patients receiving bone marrow transplantation. Furthermore, 90% of patients do not need to undergo blood transfusion during treatment with Antroquinonol (Hocena). Oral treatments and the decrease in blood transfusions have greatly improved the quality of life of AML patients. There is no significant side effect (SAE) that has occurred during the 6-month treatment period. The dose trial is administered orally at home by taking 200 mg twice a day.

The trial of Antroquinonol (HOCENA), Protocol No. GHAML-2-001, was an open-label, non-randomized, Phase 2a study to evaluate efficacy and safety/tolerability profiles in adult patients with relapsed acute myeloid leukemia (AML) or at initial diagnosis when no intensive treatment is possible.

There is no standard treatment for relapsed/refractory adult acute myeloid leukemia (AML) patients. Based on the confidence achieved in the trial results for the treatment of second-line and recurrent AML patients, GoldenBiotech will apply the clinical trial (IND) to the U.S. FDA for the Phase 2 clinical trials as the first-line treatment of AML and continue to expand the spectrum of indications of Antroquinonol in other leukemia treatment fields including multiple myeloma (MM), chronic myelogenous leukemia (CML), and pediatric leukemia.

The majority of AML patients need to undergo blood transfusions and chemotherapy to kill cancer cells due to abnormal differentiation of blood cells and proliferation of myeloblasts. Current therapies are combined with chemotherapy often causing serious side effects resulting in poor prognosis of treatment for relapsed AML patients. AML ranks the second highest incidence in all leukemia but it has the highest mortality rate and the lowest five-year survival rate (about only 25%).

It is estimated that there will be about 62,000 patients with acute myeloid leukemia (AML) in 2020. According to the reports from GlobalData and other institutions, the global AML therapeutic drug market is expected to increase from USD 1.4 billion in 2019 to 5.1 billion in 2029 with a compound annual growth rate (CAGR) of 13.6%.

Tags : #GoldenBiotech #Ghaml-2-001 #Antroquinol #NewsGrugforAMLdisease #AcuteMyeloidLeukamia

About the Author


Team Medicircle

Related Stories

Loading Please wait...
-Advertisements-




Trending Now

Dr. Priti Mehta, a Pediatric hematologist Oncologist explains the facts about Pre-implantation genetic diagnosisJanuary 21, 2021
The best way to lose weight is to not think about losing weight says Karishma Shah, Nutrition ConsultantJanuary 21, 2021
Demystifying Greenfield Pharma projects and Investment for the beginnersJanuary 21, 2021
Maharashtra COVID Update: Over 50,000 given COVID vaccine shots in three sessions so far January 21, 2021
1,12,007 beneficiaries vaccinated against Coronavirus, covering 11% health workersJanuary 21, 2021
Kerala continues to report surge in COVID cases with 6815 new casesJanuary 21, 2021
US studies claims vaccines are effective against the new Covid-19 strains January 21, 2021
Madhya Pradesh: Bird Flu virus found in 32 districts of state so farJanuary 20, 2021
Karnataka Health Minister expresses hope of launching Arogya Karnataka emergency health servicesJanuary 20, 2021
India starts shipments of Made in India COVID-19 Vaccines to neighbouring countriesJanuary 20, 2021
COVID-19 recovery rate improves to 98.13 pct in JharkhandJanuary 20, 2021
National COVID-19 recovery rate improves to 96.70 per centJanuary 20, 2021
Benefits of coconut waterJanuary 20, 2021
The RSA Group welcomes Eleanor Davies as Managing PartnerJanuary 19, 2021
Mask-wearing linked to reduced COVID-19 transmission, US modelling study suggestsJanuary 19, 2021
Tessa Therapeutics receives PRIME designation from EMA for CD30 CAR-T TherapyJanuary 19, 2021
FUJIFILM Diosynth Biotechnologies begins production of two COVID-19 vaccinesJanuary 19, 2021
Fried food intake linked to heightened serious heart disease and stroke riskJanuary 19, 2021
‘’What is more dangerous is that we don't have any kind of criteria to be a coach,’’ says Parag Patil, Founder, LetzRun India, and MaxFit IndiaJanuary 19, 2021
‘’The younger generation must understand that health and fitness is at least a Forty-year commitment, and not a four-month game,’’ says Shreeharsh Deshmukh, Trainer, and Nutritionist, The Fit problemJanuary 19, 2021