Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Cell Therapeutics (CTI) has received Italian Medicines Agency (AIFA) approval for its facility at NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy) for the production of its drug candidate Pixantrone.
Subscribe to our email newsletter
CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.
CTI is in the process of preparing a marketing authoriation application (MAA) in the EU for Pixantrone to treat relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL).
Pixantrone (6,9-bis[(2-aminoethyl)amino]benzo[g]isoquinoline-5,10-dione; rINN) is an experimental antineoplastic drug, an analogue of mitoxantrone with less toxic effects on cardiac tissue. It acts as a topoisomerase II poison and intercalating agent. The code name BBR 2778 refers to pixantrone dimaleate, the actual substance commonly used in clinical trials.
Craig Philips, president of CTI, said: “We are pleased that the AIFA has approved the NerPharMa facility to manufacture Pixantrone as we continue to receive positive feedback on the clinical trial results from leading clinicians in Europe and make progress in the submission of the MAA in Europe.”