TLC announced that the first patient has been dosed a Phase II clinical trial for TLC590 following bunionectomy.
SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, March 18, 2019 (GLOBE NEWSWIRE) -- TLC (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 osteoarthritis, pain management, ophthalmology and oncology, today announced that the first patient has been dosed a Phase II clinical trial for TLC590 following bunionectomy. TLC590 is a proprietary BioSeizer™ liposomal formulation of ropivacaine engineered to provide fast and sustained postsurgical pain relief for up to 96 hours, as recently demonstrated in a Phase I/II clinical trial.
The Phase II, randomized, double-blind, comparator- and placebo-controlled clinical trial will evaluate the safety, pharmacokinetics, and efficacy of TLC590 compared with ropivacaine and placebo via a single infiltrative local administration in approximately 200 patients following bunionectomy across five sites in the US. The study will be divided into two parts. Part 1 will evaluate the pharmacokinetics, safety, and efficacy of three different doses of TLC590 and ropivacaine in 48 patients. Part 2 will have a larger patient size and include both ropivacaine and saline placebo as comparators.
The primary endpoint is area under the curve (AUC) of the numerical pain rating scale, and key secondary endpoints include the proportion of pain-free patients, the proportion of opioid-free patients, time to first postsurgical opioid use, and total opioid consumption.
“We continue to rapidly advance the clinical development of our pain management portfolio and are pleased with this milestone and the faster than expected patient enrollment rate so far,” said TLC President George Yeh. “We anticipate results from Part 1 of this trial to be available by mid-2019. I look forward to sharing those results, which I believe will once again demonstrate TLC590’s potential to become a non-opioid alternative in addressing the serious and unmet medical need in postsurgical pain management.”
About TLC590
TLC590 is a non-opioid BioSeizer sustained release formulation of ropivacaine. 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.
About TLC
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, and improve active drug concentrations 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 postsurgical pain management, 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.
Media Contact: Dawn Chi Corporate Communications +886 2 2655 7377 ext. 136 dawn@tlcbio.com Investor Contact: Xuan Yang Solebury Trout +1 646 378 2975 xyang@troutgroup.com
