Taiwan Liposome announces part 1 analysis of Phase 2 TLC590 trial
Taiwan Liposome, or TLC, announced results from the pre-planned analysis of part 1 of TLC590's Phase 2 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. 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, or 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.