PCT and SOTIO sign Phase 3 manufacturing services agreement

According to the agreement, PCT will complete a technology transfer of SOTIO’s current product manufacturing and analytical procedures into PCT’s ongoing CDMO operations.

PCT will subsequently implement and perform process qualification at the Allendale facility, and manufacture, store, and release the product for SOTIO’s US part of its global pivotal Phase 3 trial.

PCT president and chief scientific officer Robert Preti said, "PCT will offer SOTIO, LLC the same expertise and dedicated service it has offered past clients like the Dendreon Corporation (DNDN), for whom we were the primary manufacturer for PROVENGE for more than seven years during its clinical trials."

The US part of the double-blinded, randomized trial is expected to enroll up to 250 patients.

SOTIO chairman and CEO Karel Nohejl said PCT has significant experience in manufacturing patient-specific products and capabilities to provide the scale-up needed for late-stage clinical trials.

"PCT’s competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for SOTIO, LLC as we look forward to launching this trial in anticipation of entering the U.S. market," Nohejl added.