The success of the treatment has led to a strange but welcome anomaly, Professor Kumana said. In the 1990s, the prevalence of the disease was near zero per 100,000 persons and over about 20 years it has increased by sixty-fold, even though the annual number of new cases has remained steady. ‘The reason is that it was so rapidly lethal before that if we looked for surviving people with this disease, almost none could be found. Now there are many,’ he said. International Rollout The team is not stopping here. ‘Our focus now is on global registration,’ said Professor Gill. They have collaborated with counterparts in Asia through the APL Asian Consortium to do a multicentre study supported by Hong Kong’s Innovation and Technology Fund. HKUMed leads the Consortium, which has members from Hong Kong, Singapore, Malaysia and Taiwan. Professor Gill and his team are also working with researchers in the Greater Bay Area and Singapore to conduct studies there, and oral-ATO has been approved by the Guangdong Provincial Medical Products Administration for clinical use via the HKU-Shenzhen Hospital. The studies in the US and Europe are expected to start within a year and involve industry partners, while the UK AML Research Network and University of Cardiff are collaborating with the HKUMed team to do a nationwide Phase 3 study funded by Blood Cancer UK. The team responsible for developing oral-ATO believe there are credible grounds for inferring that ATO could also have a role in the treatment of several diseases/ disorders other than APL (e.g. Systemic Lupus Erythematosus). If planned ongoing investigations confirm such potential benefits, the scope for deploying oral-ATO therapy is likely to expand considerably. ‘While the story of oral-ATO is a great tale of success for HKUMed, it is also a testimony of how times have changed in Hong Kong,’ said Professor Kwong. He noted that when they started out over 25 years ago, there was not a general focus on innovation. The team persisted anyway, knowing they had developed a drug that could be vitally important for APL patients. Now, they are well supported with both funding and recognition in Hong Kong and around the world. ‘It has been a long process, but it is gratifying to see that the mindset has changed,’ he remarked. Hospital Authority of Hong Kong approved the listing of ARSENOL® (oral-ATO), making it available for clinical use and research in Hong Kong, Macau and Southeast Asia 香港醫院管理局批准藥用口服砒霜(ARSENOL®)列入 醫院管理局藥物名冊,並獲准於香港、澳門和東南亞地區 作臨床及研究使用 Approved by the Guangdong Provincial Medical Products Administration (GDMPA) for clinical use in the Greater Bay Area via the HKU-Shenzhen Hospital 獲得廣東省藥品監督管理局(GDMPA)批准在大灣區 (通過香港大學深圳醫院)作臨床使用 As part of the first steps in placing oral-ATO in the international arena of medicine, oral-ATO obtained orphan drug designation (ODD) from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as an investigational new drug designation (IND) from the US FDA 獲得美國食品及藥物管理局(FDA)及 歐洲藥品管理局(EMA)的罕見病藥物 資格認定(孤兒藥,orphan drug designation,ODD),亦同時取得美國 FDA新藥臨床研究資格認定 (investigational new drug designation, IND),預計將藥品推向國際醫療舞台 2020 2025 GBA 2022 ‘While the story of oralATO is a great tale of success for HKUMed, it is also a testimony of how times have changed in Hong Kong.’ Professor Kwong Yok-lam 25 HKUMed News Summer 2025
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