TLC Announces Acceptance of Manuscript on Anti-COVID-19 Program by Clinical and Translational Science Journal
03 Novembre 2020 - 1:37PM
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty
pharmaceutical company developing novel nanomedicines to target
areas of unmet medical need, today announced that the manuscript
describing how inhalable liposomal hydroxychloroquine (TLC19) may
provide clinical benefit and serve as a potential treatment for
COVID-19 has been peer-reviewed and accepted by Clinical and
Translational Science (CTS) journal. CTS highlights original
research that helps bridge laboratory discoveries with the
diagnosis and treatment of human disease and is an official journal
of the American Society of Clinical Pharmacology and Therapeutics
(ASCPT).
“We are honored to be sharing this peer-reviewed
manuscript in an internationally acclaimed journal,” said George
Yeh, President of TLC. “CTS has a collection of clinical
pharmacology research from various potential treatments such as
remdesivir, favipiravir, and lopinavir/ritonavir. Acknowledgment of
our work by CTS further fortifies the soundness of our strategy of
preferential delivery to the lungs. In these unprecedented times,
we wish to do all that we can to help, and we openly welcome
partnerships to re-formulate drugs with high potency against
SARS-CoV-2 virus but low bioavailability utilizing our proprietary
inhalable liposomal formulation in order to create more potential
remedies to address this global pandemic.”
The accepted manuscript titled “A Strategy to
Treat COVID-19 Disease with Targeted Delivery of Inhalable
Liposomal Hydroxychloroquine: A Pre-clinical Pharmacokinetic Study”
can be found on the ASCPT website using the following link:
https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1111/cts.12923.
The research, which was previously available as pre-print on
bioRxiv.org, is a collaborative work by TLC in conjunction with key
opinion leader in respiratory therapies – Dr. Huey-Dong Wu, Senior
Pulmonologist at the Department of Integrated Diagnostics and
Therapeutics at National Taiwan University Hospital – and the
leading authority in infectious diseases – Dr. Yee-Chun Chen,
Professor of Medicine at National Taiwan University Hospital and
College of Medicine, Investigator of the National Institute of
Infectious Diseases and Vaccinology, National Health Research
Institutes of Taiwan, and Board Member and Vice President of the
International Society for Human and Animal Mycology (ISHAM).
“There is an unmet medical need for a therapy
that is accessible and affordable for everyone affected by the
COVID-19 pandemic,” said Dr. Chen. “Altering the route of
administration of hydroxychloroquine from oral to inhalation
substantially increases exposure in the airways and lungs while
decreasing exposure in the system, and a liposomal formulation
allows sustained residence of the drug in the lungs. I am happy to
see these principles reflected in the results of this preclinical
study and look forward to seeing more encouraging data from the
clinical trials.”
A Phase I randomized, vehicle-controlled,
blinded study evaluating the safety, tolerability, and
pharmacokinetics of inhaled TLC19 in healthy volunteers is
ongoing.
About TLC19TLC19 is a 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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