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Cell Therapeutics to Re-submit Pixantrone NDA in Consideration for Accelerated Approval in Accordance with Guidance from FDA's Office of New Drugs
Date:5/2/2011

M.D., CEO of CTI. "This was the right decision in the interests of patients with relapsed refractory aggressive NHL beyond second line therapy for whom there are no approved or effective drugs." 

As a result of this important new development, the Company plans to move quickly to request a meeting with the appropriate Division of the FDA's Office of Oncology Drug Products and to submit the requested information, as well as all other relevant data requested in the Complete Response Letter, in a re-submission as soon as practical.  Under the Prescription Drug User Fee Act ("PDUFA") guidelines, the re-submitted NDA would have a 6 month review cycle.

Conference Call Information

On Tuesday, May 3, 2011, at 8:30 a.m. Eastern time/2:30 p.m. Central European time/5:30 a.m. Pacific time, members of CTI's management team will host a conference call.

Conference Call Numbers
Tuesday, May 3, 2011 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time

1-877-941-9205 (US Participants – Toll-Free)
1-480-629-9835 (US Participants)

800-149-070 (Italy Participants – Toll-Free)
39-02-30-350-9038 (Italy Participants)

Call-back numbers for post-listening available at 11:30 a.m. Eastern Time:

1-800-406-7325 (US Participants)
1-303-590-3030 (International)

Passcode: 4438455#

Live audio webcast at www.celltherapeutics.com will be archived for post-call listening approximately two hours after call ends.

About Pixantrone

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines--rather than intercalation with DNA---- pixantrone alkylates DNA-- forming stable DNA adducts wi
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SOURCE Cell Therapeutics, Inc.
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