TLC Doses First Patients in Phase I/II Trial of TLC590 for Postsurgical Pain Management

TAIPEI, Taiwan and SOUTH SAN FRANCISCO, Calif., Aug. 14, 2018 (GLOBE NEWSWIRE) -- Taiwan Liposome Company, Ltd. (4152.TWO; “TLC”), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of medical needs in pain management, ophthalmology, and oncology, today announced the dosing of the first patients in a Phase I/II trial for TLC590. To date, the trial has enrolled 12 patients, 3 of whom were dosed on August 13, 2018. TLC590 is a proprietary BioSeizer™ liposomal formulation of ropivacaine engineered to provide fast onset, sustained release, and postsurgical pain relief.

The Phase I/II trial is a randomized, double-blind, comparator-controlled, dose escalation study to evaluate TLC590 compared to free, non-liposomal ropivacaine when given as a single infiltrative local administration in adult patients following inguinal hernia repair surgery. The objective of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), dose-exposure relationships, and analgesic efficacy of dose escalation of TLC590 compared to free, non-liposomal ropivacaine. The trial is taking place in the United States and will enroll approximately 64 evaluable patients who will receive follow-up for 30 days after surgery and dosing.

“TLC590 is formulated with our proprietary BioSeizer liposome technology, which has a dense multilamellar structure capable of providing high concentration drug loading and continuous release of ropivacaine,” commented Dr. Keelung Hong, inventor of TLC590 and Founder, Chairman and Chief Executive Officer of TLC. “Our preclinical studies have shown TLC590 to display statistically significant analgesic efficacy compared to liposomal bupivacaine, and we are excited to have begun dosing patients in our first-in-human clinical trial to demonstrate TLC590 as a potentially best-in-class drug for postsurgical pain management that may serve as a safe, non-opioid solution to the opioid epidemic.”

About TLC590
TLC590 is a non-opioid BioSeizer sustained release formulation of ropivacaine, a common local anesthetic drug belonging to the amino amide group that was developed after bupivacaine. Ropivacaine has been found to have less cardiovascular and central nervous system toxicity than bupivacaine, which is the active drug in an extended release product currently available in the U.S. that demonstrated significant efficacy up to 24 hours post-surgery, but showed minimal to no efficacy 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 systemic exposure. 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 extended release bupivacaine at equipotent dose.

About TLC
TLC (4152.TWO) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of best-in-class 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 without incurring large systemic exposures. TLC’s BioSeizer technology enables local sustained release of therapeutic agents at the site of disease or injury; its NanoX targeted delivery technology enables prolonged pharmacokinetic profiles and enhanced 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 may contain forward-looking statements. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the clinical development of TLC590 for the treatment of postsurgical pain management, the potential clinical benefits of TLC590, the size, scope and results of the trial for TLC590, the expected enrollment in, scope, results and the timing of clinical trials. Words such as “may,” “believe,” “will,” “plan,” “potential” 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 unknown risks, assumptions, uncertainties and factors that are beyond TLC’s control. 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.

Contacts:

Taiwan Liposome Company (TLC) Dawn Chi Corporate Communications +886 2 2655 7377 ext. 136 dawn@tlcbio.com

Solebury Trout Julia Balanova Vice President +1 646 378 2936 jbalanova@trougroup.com