Paula Bronstein / Getty Images News via Getty ImagesTaiwan Liposome Co. Ltd. (NASDAQ: TLC) shares shot up on Wednesday after the firm announced that it would be able to move forward with its COVID-19 trial that uses hydroxychloroquine. In the past, hydroxychloroquine has been viewed as a controversial drug in terms of evaluating its efficacy in treating COVID-19, but now there seems to be a definitive ruling on it—at least in Australia and Taiwan.
In terms of the specifics, the company announced the receipt of ethical and scientific approval from the Bellberry Human Research Ethics Committee (HREC) in Australia for the company’s Phase 1 clinical trial of TLC19 hydroxychloroquine liposome inhalation suspension for COVID-19.
The HREC is constituted in accordance with the requirements of the National Health & Medical Research Council (NHMRC), and it reviews clinical trial proposals to ensure that they are ethically and scientifically acceptable and have been developed in accordance with relevant standards and guidelines.
The approval comes following the acceptance of Taiwan Liposome’s investigational new drug (IND) application with the Taiwan Food and Drug Administration (TFDA) on Tuesday.
Ultimately, the Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses of inhaled TLC19 in 30 healthy volunteers.
Management said that it is very much looking forward to launching TLC19’s Phase 1 trial with the support of experienced, high-quality partners in Taiwan as well as in Australia, which has an efficient and globally recognized regulatory environment with the bonus of government incentives and benefits and is a great place to conduct clinical trials for time-sensitive projects like TLC19.
Excluding Wednesday’s move, Taiwan Liposome stock had underperformed the broad markets with a retreat of about 18% year to date. In the past 52 weeks, the share price was down closer to 13%.
Taiwan Liposome stock traded up about 42% to $6.17 on Wednesday, in a 52-week range of $2.48 to $12.65. The consensus price target is $12.75.
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