HKUMed’s oral arsenic trioxide gains global recognition for treating leukaemia
Researchers from the LKS Faculty of Medicine at the University of Hong Kong (HKUMed) have developed a breakthrough in leukaemia treatment. Their oral formulation of arsenic trioxide (Oral-ATO; Arsenol) for acute promyelocytic leukaemia (APL) , an incurable disease, is the first prescription medicine wholly invented and manufactured.
Extensive clinical studies have demonstrated the high efficacy of Oral-ATO, with an overall survival rate exceeding 97%. A 15-year prospective study of over 400 relapsed APL patients achieved a 100% molecular remission rate and an 80% five-year survival rate without the need for bone marrow transplants. Further trials incorporating Oral-ATO into frontline treatment resulted in a 100% five-year survival rate. The research team has also introduced an entirely oral regimen, combining Oral-ATO with all-trans retinoic acid (ATRA) and ascorbic acid (AAA), reducing reliance on chemotherapy.
The US FDA and EMA have granted Oral-ATO orphan drug designation (ODD), establishing regulatory requirements for oral-ATO studies in the USA and Europe. HKUMed researchers will collaborate with industry partners to launch these clinical studies in Hong Kong, North America, and Europe this year.
HKUMed leads the APL Asian Consortium, which includes researchers from Malaysia, Singapore, and Taiwan. The group has shown that the AAA regimen outperforms traditional chemotherapy-based approaches. Oral-ATO is already available for clinical use in the Greater Bay Area through HKU-Shenzhen Hospital and is being evaluated in Singapore, Malaysia, and Taiwan.
The UK is also set to explore the benefits of Oral-ATO. The UK AML Research Network and the University of Cardiff, in collaboration with HKUMed, secured funding from Blood Cancer UK for a nationwide Phase 3 study. Clinical trials will soon begin in North America and Europe, supported by industry partnerships.
Dr Harinder Gill, the study’s lead investigator, described the development of Oral-ATO as a transformative moment for APL patients, offering a safer and more accessible treatment. With global research collaborations underway, HKUMed aims to establish Oral-ATO as a new standard of care, ultimately making APL a curable disease worldwide.
Category: Education
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