Recipharm will supply clinical trial materials to PledPharma for its Phase IIb trial with PledOx, PLIANT, following the FDA’s IND approval. The material for PLIANT has been manufactured by Recipharm Pharmaceutical Development.
Recipharm Pharamaceutical Development’s general manager, Maria Lundberg, said, “We are delighted to contribute to the development of a new product that may reduce serious side-effects of the chemotherapy in patients treated for advanced colorectal cancer. Furthermore, manufacturing material for an FDA-approved clinical study reflects the highest standards of service quality and capabilities that Recipharm provides to its customers, meeting the expectations and demands of today’s competitive market place.”
Jacques Näsström, chief executive officer of PledPharma, said, "We are very pleased with the positive assessment by the FDA. Since the U.S. is perhaps the single most important market, it is particularly encouraging that we received approval for our study there.”