Sun Pharma Advanced Research Company Ltd. (SPARC) announced top-line results of the pivotal BE study for Paclitaxel Injection Concentrate for Suspension (PICS).
The pivotal BE study was a randomized, open label, two period, single dose, crossover study of PICS and Abraxane® in subjects with locally recurrent or metastatic breast cancer. A total of 142 patients were randomized to characterize the pharmacokinetic (PK) profile of PICS for both unbound and total paclitaxel compared with Abraxane®. The study also provided information on the safety profile of PICS.
The study met all the required pharmacokinetic endpoints for both unbound and total paclitaxel. There were no new adverse events observed in this study.
About Paclitaxel Injection Concentrate for Suspension
Paclitaxel Injection Concentrate for Suspension (PICS) is a novel formulation of Paclitaxel developed using SPARC’s proprietary NanotectonTM technology. PICS is a Cremophor® and Albumin-free formulation of Paclitaxel. PICS offers the convenience of a quick and easy “one step” dilution and infusion preparation. PICS, unlike solvent based formulations, does not require premedication with steroids or antihistamines.
Sun Pharma Advanced Research Company Ltd. (SPARC) is a global pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery. SPARC aims to consistently lower costs and improve operational efficiencies to advance availability and affordability of cures for patients across the world.