TLC Announces Part 1 Analysis of TLC590 Phase II Clinical Trial for Postsurgical Pain Management following Bunionectomy
SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, June 14, 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 results from the pre-planned analysis of Part 1 of TLC590's Phase II clinical trial in patients following bunionectomy. TLC590 is a proprietary BioSeizer® liposomal formulation of ropivacaine intended for the relief of postsurgical pain.
Part 1 of the two-part Phase II clinical trial, conducted in California and Utah, was a blinded safety and pharmacokinetic study to establish the tolerability and relative bioavailability of TLC590 and ropivacaine. A total of 50 patients were randomized in a ratio of 1:1:1:1 into four groups/arms to receive 152, 190, and 228mg of TLC590 or ropivacaine 50mg.
Key findings from the analysis are as follows:
- Dose linearity and relative bioavailability of TLC590 have been established.
- All three doses of TLC590 were well tolerated, with a safety profile comparable to ropivacaine.
- Most treatment-emergent adverse events (AEs) were mild to moderate in severity.
- There were no treatment-related or serious AEs, and no AEs leading to withdrawal.
- TLC590 228mg is the dose chosen to move forward based on maximum feasible volume for bunionectomy.
"The rapid enrollment of Part 1 allowed us to promptly understand the pharmacokinetics of TLC590 in an orthopedic setting," commented TLC Chief Medical Officer Dr. George Spencer-Green. "As a clear linear pharmacokinetic profile was observed and there were no safety concerns with any of the dose groups, we have selected the 228mg dose to move forward into Part 2, as it represents the largest feasible volume in this small surgical wound model and should provide a substantial duration of exposure."
Ropivacaine was developed as the next generation of local anesthetics, after bupivacaine was found to be associated with cardiac side effects. Despite the reduced central nervous system and cardiovascular toxicities of ropivacaine, many anesthesiologists continue to choose bupivacaine for its longer-lasting duration. In-depth conversations with opinion leaders in anesthesiology have indicated a demand for a single product with an improved safety profile that is capable of providing both early as well as prolonged pain relief.
"In our recent communications with regulatory bodies, we received feedback that, although ropivacaine is known to have a better safety profile, bupivacaine is still more commonly used as wound infiltration anesthesia," commented TLC President George Yeh. "Expansion into Part 2 will therefore include bupivacaine as a relevant active comparator for assessment of TLC590's clinical benefit over the existing therapy; safety and efficacy of TLC590 will be analyzed against bupivacaine as well as placebo."
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. In a Phase I/II clinical trial in patients following hernia repair surgery, TLC590 demonstrated durable, statistically significant and clinically meaningful improvement over the standard of care through 96 hours. 58.3% of patients who received TLC590 did not use any rescue opioids at all through the duration of the study; among those who did use rescue opioids, time to first postsurgical opioid use was about four times that of the ropivacaine group (standard of care), and mean total opioid consumption was 54% less through 96 hours post-surgery. A Phase II clinical trial in patients following bunionectomy is ongoing.
Taiwan Liposome Company, Ltd. ("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.
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