Pacira BioSciences (PCRX) said Monday that it has enrolled the first patient in part B of its mid-stage trial evaluating PCRX-201, an investigational gene therapy for osteoarthritis of the knee, after successfully transitioning the therapy to a US-based commercial-scale manufacturing process.
Enrollment in Part A concluded last month, with topline data expected by the end of the year, the company said.
Pacira said the manufacturing transition, together with PCRX-201's Regenerative Medicine Advanced Therapy designation and encouraging early-stage results, supports the program's future late-stage development.
The company said the manufacturing change was completed without delaying the ongoing mid-stage trial.
Comments