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Cell Therapeutics, Inc. (CTI) Reports Fourth Quarter and Year-End Financial Results and Milestones
Date:3/6/2012

al approval of CTI's marketing authorization application (the "MAA") for Pixuvri to treat adult patients with multiple relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL").

"We expect that in the next few months the European Commission should adopt the CHMP's opinion for this unmet medical need and for the first time patients with multiple relapsed or refractory aggressive NHL in the E.U. will have an approved therapy to treat their disease," stated James A. Bianco, M.D., CEO of Cell Therapeutics, Inc. "We are working with consultants on developing a staffing, resource and product launch plan for Europe so upon marketing authorization and national reimbursement approvals, we can be in a position to bring Pixuvri to these patients.  With approximately 12,000 potential patients each year in the EU(1) this represents an attractive initial commercial opportunity for CTI."

"At the same time, we are moving our other late stage product candidates forward including a March meeting with the U.S. Food and Drug Administration for the phase 3 tosedostat trial in myelodysplastic syndrome ("MDS"), a precursor of acute myeloid leukemia ("AML"). Additionally a multi-center, phase 2 study with OPAXIO treating malignant brain cancer is underway based on encouraging results from the previous study in this disease. With the potential commercial launch of Pixuvri, coupled with the successful in-licensing of tosedostat, we continue to explore additional novel clinical stage compounds to expand our hematologic cancer product pipeline," Bianco added.

  • EMA's CHMP granted a positive opinion for conditional approval of CTI's MAA for Pixuvri as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive NHL.
  • The final OPAL phase 2 results of tosedostat, which demonstrated significant response rates in elderly patients with refractory or relapsed AML, were presented in an oral session at the American Soci
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