again the results were highly encouraging, with a fiveyear leukaemia-free rate of 90% and an overall survival rate of 97%. Then in 2013, they tested it as, frontline treatment for newly diagnosed APL patients. The results were excellent with five-year leukaemia-free and overall survival rates of 100%. ‘The development of oral-ATO is of historic importance for medicine in Hong Kong,’ said Professor Kwong, ‘because we are the first to invent and make a prescription medication here.’ Apart from effectively curing patients, the oral formulation is also less toxic because it can be absorbed more gradually than intravenous injections, and it is much less expensive. The retail cost of typical dosing with intravenous ATO can cost from US$10,000 (HK$78,000) a week, while oral-ATO costs less than a tenth of that. Besides, substantial savings also ensue because patients do not have to stay in hospital for the treatment. The drug was patented in the US, Europe and Japan more than 15 years ago, but taking it from experimental to prescription medication was still a challenge. First, it needed to be manufactured to a GMP (good manufacturing practice) standard. Professor Kwong said they worked with HKU’s Technology Transfer Office to find a suitable partner. Next, they needed to get it approved for use in Hong Kong before they could ask other medical jurisdictions to approve it. This was complicated by the fact that the Department of Health (DH) had never handled a drug developed in Hong Kong before. It typically registered drugs only if they had been approved by at least two other medical jurisdictions, such as the FDA and EMA. But the team finally convinced the DH of the quality of their research and around 2018, the drug was approved for prescription use in Hong Kong. Since then, an entirely oral regimen, called frontline AAA and consisting of oral-ATO, all-trans retinoic acid and ascorbic acid (Vitamin C), has been administered to APL patients in Hong Kong, obviating the need for any chemotherapy. During the maintenance phase of treatment, patients visit the clinic every two months to pick up medication that they take for two weeks (followed by six weeks recovery) over two years. Side effects are minor and reversible, such as mild headaches and bloating – very unlike chemotherapy. Phase 1-2 Trials of oral-ATO on relapsed acute promyelocytic leukaemia (APL) in Hong Kong started 開始藥用口服砒霜對復發急性早幼粒細胞白血病進行 1-2 期追蹤研究 Oral-ATO based regimen replaced conventional regimens in Hong Kong 香港開始以藥用口服砒霜為基礎的 療法取代APL傳統療法 Oral-ATO incorporated into frontline induction of APL in Hong Kong 藥用口服砒霜納入香港 APL 的 前線誘導療程 Oral-ATO based chemotherapy-free protocol implemented in Hong Kong 香港實施以藥用口服砒霜為基礎的 無化療方案 2000 2013 2001 2018 Milestones of ARSENOL® development 藥用口服砒霜研發里程碑 FEATURE+ ‘Oral-ATO is a gamechanger for APL patients because it is life-saving, costeffective and preserves patients’ quality-of-life.’ Professor Harinder Gill 24
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