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news.Cell Therapeutics (CTI) has entered into a five-year manufacturing agreement with NerPharMa DS, a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences, for commercial and clinical supply of Pixantrone.
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Pixantrone is a new aza-anthracenedione. Similar to anthracyclines, Pixantrone inhibits Topo-isomerase II but unlike anthracyclines, rather than intercalation with DNA, Pixantrone alkylates DNA, forming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites.
CTI is developing Pixantrone as a treatment option for patients with relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL).
CTI is expected to submit a marketing authorisation application (MAA) in the European Union, and plans to initiate a Phase III trial of Pixantrone in patients with relapsed or refractory aggressive NHL in the US this year.
CTI said that the facility at NerPharMa for the production of Pixantrone was approved by the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy.
Craig Philips, president of CTI, said: “We are pleased to have reached an agreement with NerPharMa for the long-term manufacture of Pixantrone.”