TLC (NASDAQ:TLC) has received ethical and scientific approval for its phase I clinical study of TLC19 Hydroxychloroquine Liposome Inhalation suspension for COVID-19 form the Bilberry Human Research Ethics Committee in Australia.
Ethical and scientific approval vital in the development process of TLC19
The HREC, which is constituted according to the requirement s of the National Health and Medical Research Council, reviews clinical study proposals. The aim is to ensure the studies are scientifically and ethically acceptable to develop as per the relevant guidelines and standards. The approval of TCL’s study comes at the back of accepting its Investigational New Drug application by the Taiwan Foods and Drug Administration.
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George Yeh, the company’s president, stated that Taiwan has largely been recognized internationally for its success measures in the fight against COVID-19. The government launched the “Taiwan Can Help” initiative, and as part of the efforts, TLC is dedicated to accelerating the provision of a hands-on bridging strategy that will help in fighting the spread of the virus until an effective and safe vaccine is discovered. Yeh added that the company looks forward to launching the phase 1 study of TLC19 with the support of high-quality and experienced partners ion Taiwan and Australia.
Australia ideal for trials because of government support
Australia’s choice is due to its efficient and supportive regulatory environment alongside government benefits and incentives, which makes it an ideal place to conduct clinical studies for sensitive projects such as TLC19. The president said that the ethics approval reception is a huge milestone in the clinical trial notification application process.
The Phase 1 randomized, blinded, vehicle-controlled study will evaluate tolerability, pharmacokinetics, and safety of single ascending dose of inhaled TLC19 in 30 healthy subjects. TLC will use data from the trial to form a basis for subsequent clinical studies in COVID -19 patients.
Most importantly, Australia has a diverse subject enrolment pool. The government offers financial rebates of 40% or more to clinical study spending under the R&D tax incentive program.