TLC Receives Australian and Taiwan Approval to Initiate Phase I Clinical Trial of TLC19 Inhalable Liposomal Hydroxychloroquin...
October 06 2020 - 11:53PM
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty
pharmaceutical company developing novel nanomedicines to target
areas of unmet medical need, today announced the receipt of ethical
and scientific approval from the Bellberry Human Research Ethics
Committee (HREC) in Australia for the Company’s Phase I clinical
trial of TLC19 Hydroxychloroquine Liposome Inhalation Suspension
for Coronavirus disease 2019 (COVID-19). The HREC is constituted in
accordance with the requirements of the National Health &
Medical Research Council (NHMRC), and 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 TLC’s investigational new drug (IND) application with
the Taiwan Food and Drug Administration (TFDA) yesterday.
“Taiwan has been widely recognized by the
international community for successful measures taken in the battle
against COVID-19. As a part of the government’s ‘Taiwan Can Help’
initiative, TLC is committed to the speedy provision of a practical
bridging strategy to fend off the spread of the virus until a safe
and effective vaccine becomes widely available,” said George Yeh,
President of TLC. “We very much look 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. The receipt
of this ethics approval is an important step in our clinical trial
notification (CTN) application process.”
The Phase I randomized, vehicle-controlled,
blinded study will evaluate the safety, tolerability, and
pharmacokinetics of single ascending doses of inhaled TLC19 in 30
healthy volunteers. Data from this trial will serve as a basis for
subsequent clinical trials in patients with COVID-19.
Australia has a diverse participant recruitment
pool, and the Australian government offers a financial rebate of
40% or more on clinical trial spending under the Research &
Development tax incentive program.
About TLC19
TLC19 is liposomal suspension of
hydroxychloroquine (HCQ) for inhalation. HCQ has shown potential in
prophylaxis and/or treatment for COVID-19 in in vitro and
preliminary clinical trial studies, but orally administered HCQ
cannot reach therapeutic levels due to its dose-limiting
toxicities. TLC19 utilizes ~1% of the highest oral HCQ dose tested
and delivers the drug directly to the airways and lungs,
potentially avoiding systemic toxicities associated with oral HCQ
while providing a sustained effective concentration at the primary
site of infection. TLC19 is designed to be cost-effective, easily
accessible and can be self-administered with a portable
nebulizer.
About TLC
TLC (NASDAQ: TLC, TWO: 4152) is a clinical-stage
specialty pharmaceutical company dedicated to the research and
development of a diverse, wholly owned portfolio of novel
nanomedicines that maximize the potential of its proprietary
lipid-assembled drug delivery platform (LipAD™), including
BioSeizer® sustained release technology and NanoX™ active drug
loading technology, which are versatile in the choice of active
pharmaceutical ingredients and scalable in manufacturing.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are not
guarantees of future performance and involve a number of risks,
assumptions, uncertainties and factors, including risks that the
outcome of any clinical trial is inherently uncertain and product
candidates may prove to be unsafe or ineffective, or may not
achieve commercial approval. Other risks are described in the Risk
Factors section of TLC’s annual report on Form 20-F for the year
ended December 31, 2019 filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on TLC’s
expectations and assumptions as of the date of this press release.
Actual results may differ materially from these forward-looking
statements. Except as required by law, TLC expressly disclaims any
responsibility to update any forward-looking statement contained
herein, whether as a result of new information, future events or
otherwise.
Contact
Dawn Chi
Corporate Communications
dawn@tlcbio.com
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