TLC completes enrolment in Phase I/II TLC590 trial

19th December 2018 (Last Updated December 19th, 2018 00:00)

Taiwan Liposome Company (TLC) has completed patient enrolment in a Phase I/II clinical trial of TLC590 following inguinal hernia repair surgery.

TLC completes enrolment in Phase I/II TLC590 trial
An incarcerated inguinal hernia as seen on CT scan. Credit: James Heilman, MD.

Taiwan Liposome Company (TLC) has completed patient enrolment in a Phase I/II clinical trial of TLC590 following inguinal hernia repair surgery.

TLC590 is TLC’s non-opioid BioSeizer sustained release formulation of ropivacaine and is developed to deliver post-surgery pain relief for up to 72 hours.

The Phase I/II randomised, double-blind, comparator-controlled, dose-escalation study has enrolled 64 patients and will be carried out in the US.

It is designed to assess TLC590 in comparison with non-liposomal ropivacaine in the form of a single infiltrative local administration in adult patients after inguinal hernia repair 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."

Enrolled patients are currently being studied in four cohorts, with 12 patients receiving TLC590 and four patients getting non-liposomal ropivacaine in each of the groups.

Topline results from the trial are scheduled to be released in the first quarter of next year.

TLC has also submitted a protocol application to begin a Phase II clinical trial of TLC590 in patients following bunionectomy.

TLC president George Yeh said: “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.”

Most of the surgical patients suffer from post-surgical pain but less than half of those patients receive adequate pain relief, according to the Journal of Pain.

According to World Bank, around 96 million surgical procedures were estimated to have performed in the US in 2012.