SEATTLE, Sept. 11, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced the initiation of the commercial launch of Pixuvri® in the European Union ("E.U.") with entry into Sweden, Denmark and Finland in September, to be followed by Austria and Norway in early October 2012 and Germany, United Kingdom and the Netherlands in November 2012. CTI plans to expand availability to France, Italy and Spain as well as other European countries in 2013. Pixuvri was granted conditional marketing authorization by the European Commission in May 2012 and is the first medicinal product licensed in the E.U. to treat adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin Lymphoma ("NHL"). In the E.U., there are approximately 37,000 new cases of aggressive B-cell NHL every year. 1,2
"Patients with late-stage aggressive NHL who are not eligible for, or who have not responded to, second line therapy, have very limited treatment options and a bleak outlook, with average survival of less than a year," commented Dr. Ruth Pettengell, Consultant Hemato-Oncologist at St George's Hospital, London and principal investigator of the Phase III EXTEND study. "The evidence for Pixuvri demonstrates improved efficacy over current treatment options, but without the cardiotoxicity of anthracyclines. By addressing this unmet need, Pixuvri is an important new treatment option for physicians treating this group of patients."
In the EXTEND ( Expanding the reach of anthracyclines with pi Xan Tron E in relapsed or refractory aggressive NHL Disease) study for Pixuvri, when compared with other active single-agent treatments, more patients on Pixuvri achieved a complete response or unconfirmed complete response, and also survived for longer before their disease progressed. 3 Prior to the approval of Pixuvri there was no standard of care for treating patients who failed front line and second line therapy for aggressive B cell NHL. The EXTEND trial is the only randomized controlled clinical study in this patient population establishing the standard of care for this patient population.
"We are pleased to be able to offer the first meaningful treatment option for physicians treating those patients with multiply relapsed and refractory aggressive NHL," stated James A. Bianco, M.D., President and CEO of CTI. "CTI looks forward to making this innovative product available to healthcare providers across the European Union."About Pixuvri (pixantrone) Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds, Pixuvri forms stable DNA adducts and has demonstrated superior anti-lymphoma activity compared to related compounds .4,5 Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite - both of which are the putative mechanisms for anthracycline-induced acute and chronic cardiotoxicity. 6 These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity. In May 2012, Pixuvri received conditional marketing authorization in the E.U. as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. Please refer to the Summary of Product Characteristics ("SmPC") for the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/community-register/html/h764.htm#ProcList. CTI is currently accruing patients into a Phase 3 trial comparing pixantrone and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. European sites will be participating in this study later this year.
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