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TLC Announces Phase I/II Full Enrollment in Hernia Repair Surgery and Phase II Initiation in Bunionectomy of TLC590 for Postsurgical Pain
TAIPEI, Taiwan and SOUTH SAN FRANCISCO, Calif., Dec. 18, 2018 (GLOBE NEWSWIRE) -- Taiwan Liposome Company, Ltd. (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of unmet medical need in pain management, ophthalmology and oncology, today announced the full enrollment of TLC590’s Phase I/II clinical trial in patients following inguinal hernia repair surgery, as well as a protocol submission for the initiation of TLC590’s Phase II clinical trial in patients following bunionectomy. Topline data from the Phase I/II trial is expected in the first quarter of 2019.
“We are quite pleased with the speed at which the Phase I/II trial has progressed,” noted TLC President George Yeh. “As a result of our prompt enrollment and dosing of all patients, we expect topline data on TLC590 in inguinal hernia repair surgery, a type of soft tissue surgery, in the first quarter of 2019. In addition, we are excited about the submission of a new protocol to the FDA to initiate a Phase II clinical trial studying TLC590 in patients following bunionectomy, a type of hard tissue surgery. Our goal with these two trials is to collect data in order to help validate TLC590’s potential to offer patients a fast-acting, long-lasting, non-opioid product that is as effective as opioids while exhibiting less local anesthetic system toxicities than currently available anesthetics.”
TLC590 is TLC’s proprietary BioSeizer™ sustained release formulation of ropivacaine, a non-opioid anesthetic, designed to deliver rapid pain relief after surgery and maintain it for up to 72 hours. The Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation clinical trial is evaluating TLC590 compared to free, non-liposomal ropivacaine when given as a single infiltrative local administration in adult patients following inguinal hernia repair surgery. In this trial, which is being conducted in the United States, 64 patients have been enrolled and are being evaluated across four cohorts, with 12 patients receiving TLC590 and 4 patients receiving non-liposomal ropivacaine in each cohort.
Most surgical patients experience post-surgical pain, but less than half of these patients receive adequate pain relief according to a study published in the Journal of Pain. The World Bank estimates that approximately 96 million surgical procedures were performed in the United States in 2012.
TLC590 is a non-opioid BioSeizer sustained release formulation of ropivacaine. Ropivacaine is a common local anesthetic drug belonging to the amino amide group that was developed after bupivacaine and found to have less cardiotoxicity and central nervous system toxicity than bupivacaine. An extended release bupivacaine product currently available in the U.S. demonstrated significant efficacy up to 24 hours post-surgery, but showed minimal to no difference in mean pain intensity compared to placebo between 24 and 72 hours after administration. TLC590 is designed to prolong the retention time of the ropivacaine around the injection site as a drug depot, to simultaneously extend its therapeutic period, and to reduce unwanted systemic exposure. Based on preclinical experiments, TLC believes the dense multilamellar structure of TLC590 is capable of providing high concentration drug loading and continuous release of ropivacaine to provide both immediate onset and extended pain relief of up to 72 hours. In preclinical studies, TLC590 displayed more durable and statistically significant analgesic effects compared to liposomal bupivacaine at equipotent dose.
TLC (Nasdaq: TLC, TWO: 4152) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD™). TLC believes that its deep experience with liposome science allows TLC to combine onset speed and benefit duration, while establishing drug levels at target tissues while decreasing unwanted systemic exposures. TLC’s BioSeizer technology is designed to enable local sustained release of therapeutic agents at the site of disease or injury; its NanoX active drug loading technology is designed to alter the systemic exposure of the drug, potentially reducing dosing frequency and enhancing distribution of liposome-encapsulated active agents to the desired site. These technologies are versatile in the choice of active pharmaceutical ingredients and scalable with respect to manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics that target areas of unmet medical need in pain management, ophthalmology, and oncology. TLC is consistently ranked in the top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.
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. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the clinical development of TLC590, the clinical benefits of TLC590 for people with postsurgical pain, the timing, scope, progress and outcome of the Phase I/II clinical trial and planned Phase II clinical trial for TLC590 or any other clinical trials, and the anticipated timelines for the release of clinical data. Words such as “may,” “believe,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. 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 TLC590 or any of our other 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 prospectus dated November 21, 2018 filed pursuant to Rule 424(b)(4) 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.
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