SEATTLE, July 28, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI" or the "Company") (NASDAQ and MTA: CTIC) today reported advancements in its efforts to develop its late stage oncology pipeline to market coupled with improved financial results for the second quarter ended June 30, 2011.
"In the second quarter, we seized on the momentum and the feedback provided by the FDA's Office of New Drugs ("OND") in allowing us to resubmit the pixantrone New Drug Application ("NDA") based on the PIX 301 data without requiring the Company to conduct additional clinical trials in advance of potential accelerated approval. Our type A meeting with the FDA's Division of Oncology Drug Products ("DODP") provided guidance on items in the Complete Response Letter and we are on track to provide this information, as well as the information OND requested, in the fourth quarter of 2011," said James A. Bianco, M.D., Chief Executive Officer of the Company. "With a six month review process after resubmission, approval of pixantrone in the United States may occur as early as April 2012. Similarly, our meeting in April with representatives of the European Medicines Agency ("EMA") and our Marketing Authorization Application ("MAA") co-rapporteurs provided guidance for responding to the Day 120 letter that could allow a recommendation for approval before year end."
"In addition to these significant developments in advancing pixantrone to market, encouraging phase II tosedostat results, which were reported at ASCO, suggest a target population for a phase II/III registration-directed trial, which we expect to get underway in the first half of 2012 following an FDA meeting that we will request later this year. With OPAXIO advancing to its interim survival analysis in the phase III front-line maintenance ovarian cancer study and brostallicin generating excitement in the Mayo Clinic's North Central Cancer Treatment Groups' triple negative breast cancer study, 2012 can be a p