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Cell Therapeutics Reports Third Quarter 2013 Financial Results
Date:10/30/2013

SEATTLE, Oct. 30, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported financial results for the third quarter and nine months ended September 30, 2013.

"We recently achieved an important clinical milestone in our pacritinib development program, having reached agreement with the FDA on a Special Protocol Assessment (SPA) for the planned pivotal Phase 3 PERSIST-2 clinical trial of pacritinib for patients with myelofibrosis who have low platelet counts," said James Bianco, M.D., President and CEO of CTI. "With the SPA in place, we expect to initiate this trial in the fourth quarter of 2013 and anticipate completing enrollment in approximately 12 months.  We continue to make progress with the reimbursement process for PIXVURI in the European Union and are focused on educating physicians on the unmet medical need and building brand awareness for PIXUVRI as a third- and fourth-line treatment option among physicians in countries where PIXUVRI is currently available." 

Third Quarter 2013 and Recent HighlightsPIXUVRI® (pixantrone) Commercial:  Market Access Granted in France and Italy

  • Reported that the Company was granted market access by the Transparency Commission of the French National Health Authority in France and by the Italian Medicines Agency (AIFA) in Italy for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy). 
  • Research and Development:  Reached SPA Agreement with FDA for PERSIST-2 Clinical Trial

  • Reached agreement with the U.S. Food and Drug Administration (FDA) on a SPA for the planned pivotal Phase 3 clinical trial, known as PERSIST-2,  evaluating pacritinib compared to best available therapy, including approved JAK2 inhibitors such as ruxolitinib, in patients with myelofibrosis
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