Credit score: The College of Hong Kong
Researchers on the LKS School of Medication of the College of Hong Kong (HKUMed) have invented an oral formulation of arsenic trioxide (Oral-ATO; ARSENOL) for the remedy of acute promyelocytic leukemia (APL), a blood most cancers that after had a excessive fatality charge.
The invention and use of oral-ATO is of historic significance for drugs in Hong Kong. It’s the first-ever prescription remedy wholly invented and manufactured in Hong Kong, and in addition the primary to acquire U.S., European and Japanese patents.
After greater than twenty years of devoted work, the HKU analysis crew efficiently translated this Hong Kong invention into medical follow by incorporating oral-ATO into the remedy plan of APL sufferers. In depth medical research of oral-ATO have demonstrated its excessive efficacy and security in curing APL sufferers, with an general survival (OS) charge exceeding 97%, together with a major discount in side-effects and remedy burden.
Wonderful outcomes of oral-ATO for APL
For greater than twenty years, the HKUMed analysis crew carried out in depth research on oral-ATO for APL. In a 15-year potential follow-up research of greater than 400 sufferers with relapsed APL, oral-ATO-based remedy resulted in a 100% molecular remission charge and a five-year OS charge of 80%. These outcomes have been achieved with out bone marrow transplantation, a extremely poisonous remedy that’s nonetheless utilized in many components of the world that don’t have entry to oral-ATO.
The HKUMed analysis crew then moved oral-ATO to the upkeep remedy of APL sufferers in first full remission, leading to a 90% five-year leukemia-free survival (LFS) charge and a 97% OS charge. The subsequent step was the incorporation of oral-ATO into frontline remedy of newly recognized APL sufferers, attaining 100% LFS and OS at 5 years.
The HKUMed analysis crew is presently testing frontline remedy in Hong Kong with a completely oral routine comprising oral-ATO, all-trans retinoic acid (ATRA) and ascorbic acid (AAA) for APL in a risk-adapted method.
Oral-ATO as the brand new normal of care in APL
Based on Dr. Harinder Gill, Medical Affiliate Professor within the Division of Medication, College of Medical Medication of HKUMed, the research’s lead investigator, the solely oral routine “AAA” is very efficient and protected and might be administered in an outpatient setting for all threat classes of APL sufferers. It will possibly decrease chemotherapy in sufferers in any respect threat ranges—not simply in lower-risk sufferers—in addition to in each youngsters and adults.
Recognition by the US FDA and the EMA
As a part of the primary steps in inserting oral-ATO within the worldwide area of medication, oral-ATO obtained orphan drug designation (ODD) from the US Meals and Drug Administration (FDA) and the European Medicines Company (EMA), in addition to an investigational new drug designation (IND) from the US FDA. Oral-ATO is the primary prescription anti-cancer drug invented in Hong Kong to acquire key FDA and EMA designations, that are pivotal requisites for international research of oral-ATO.
The APL Asian Consortium, led by HKUMed, brings collectively researchers from Hong Kong, Malaysia, Singapore and Taiwan to concentrate on APL analysis and remedy. Their first retrospective evaluation demonstrated the prevalence of the frontline “AAA” routine to extra typical regimens that embrace chemotherapy. The APL Asian Consortium is presently a platform for selling using oral-ATO in these areas.
Globalization of oral-ATO
Larger Bay Space (GBA) and Asia
The HKUMed researchers teamed up with researchers within the GBA (via HKU-Shenzhen Hospital) and Asia (through Nationwide College Most cancers Institute Singapore and Nationwide College Hospital, Singapore) to develop using oral-ATO. This multicenter analysis crew demonstrated a three-year OS and relapse-free survival (RFS) charge of 99% and 97%, respectively.
Oral-ATO has been accredited by the Guangdong Provincial Medical Merchandise Administration (GDMPA) for medical use within the GBA through the HKU-Shenzhen Hospital. Underneath the aegis of the Asian APL Consortium, oral-ATO is accessible for analysis and medical use on APL sufferers in Singapore, Malaysia and Taiwan.
United Kingdom
The UK AML Analysis Community and the College of Cardiff, U.Ok., in collaboration with the HKUMed analysis crew, obtained funding from Blood Most cancers UK for oral-ATO. A nation-wide Part 3 research incorporating oral-ATO will likely be investigated within the frontline administration of APL within the UK. This can be a landmark for medicinal improvement in Hong Kong.
U.S. and Europe
ODDs granted by the US FDA and the EMA present the regulatory necessities for research of oral-ATO within the U.S. and Europe. The HKUMed researchers will crew up with business companions to conduct these medical research, that are set to start in Hong Kong, North America and Europe this 12 months.
APL as a curable illness
“We take great pride in seeing our research translated into practice in Hong Kong and around the world,” mentioned Dr. Gill. “The event of oral-ATO is a game-changer for APL sufferers. It gives a handy and efficient remedy possibility that may considerably enhance their high quality of life.
“We are proud to play a pioneering role in bringing this innovation to the world and are committed to ensuring that all APL patients have access to this life-saving and cost-effective therapy. In this way, we aim to make APL a curable disease for patients around the world. As doctors, this will be our greatest achievement.”
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Oral arsenic trioxide for leukemia has a 97% remedy charge: Hong Kong’s prescription drugs enters worldwide area (2025, February 12)
retrieved 12 February 2025
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