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Tosedostat OPAL Study Final Results Selected for Oral Presentation at the 2011 American Society of Hematology (ASH) Annual Meeting
Date:12/6/2011

SEATTLE, Dec. 7, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced that final results from a study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia ("AML") was selected as on oral presentation at the 2011 American Society of Hematology ("ASH") Annual Meeting, which will be held on December 10-13, 2011, in San Diego, California.

Jorge Cortes, M.D., of The University of Texas MD Anderson Cancer Center, an investigator on the tosedostat study, is scheduled to present the data on Monday, December 12, 2011, during the "Acute Myeloid Leukemia - Therapy, excluding Transplantation: Clinical Studies" session that will be held from 4:30 p.m. to 6:00 p.m. Pacific time. The presentation, abstract #767, is titled, "Results of the OPAL Study: A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of Tosedostat (CHR-2797) in Elderly Subjects with Treatment Refractory or Relapsed Acute Myeloid Leukemia."

Additionally, results from CTI's PIX203 phase II study, in which pixantrone was substituted for doxorubicin in the CPOP-R regimen compared to the standard CHOP-R regimen in front-line aggressive non-Hodgkin's lymphoma was selected for a poster presentation.  The poster is scheduled to be presented in the "Lymphoma – Chemotherapy, excluding Pre-Clinical Models: Poster I" session on Saturday, December 10, 2011 that will be held from 5:30 to 7:30 p.m. Pacific time. The poster, abstract #1605, is titled "CPOP-R Versus CHOP-R as First-Line Therapy for Diffuse Large B-Cell Lymphoma (DLBCL): A Phase 2, Randomized, Open-Label, Multicenter Study."  

The study abstracts are available at www.hematology.org.

Investor and Analyst Meeting

Separately, CTI will host an investor and analyst meeting to present and discuss unmet medical needs in aggressive non-Hodgkin's lymphoma ("NHL"), AML and myelodysplastic syndrome, including data from CTI's product candidates pixantrone and tosedostat.  The event will take place on Saturday, December 10, 2011 in San Diego, California.

Speakers at the event will include: Bertrand Coiffier , M.D., Ph.D., Professor of Hematology at the Department of Hematology, Hospices Civils de Lyon and the University Claude Bernard in Lyon, France; Dan Douer, M.D., Leader of the Acute Lymphoblastic Leukemia Program at Memorial Sloan-Kettering Cancer Center in Boston; David Rizzerri, M.D., Professor of Medicine and Director of the Hematologic Malignancy Program in the Division of Cellular Therapy in the Department of Medicine, at Duke University Medical Center in North Carolina; and David Steensma, M.D., FACP, Associate Professor of Medicine at Harvard Medical School, consulting physician at Brigham & Women's Hospital, and a faculty member in the Adult Leukemia Program at Dana-Farber Cancer Institute in Boston.

The presentations will begin at 2:15 p.m. Eastern time / 11:15 a.m. Pacific time / 8:15 p.m. Central European time and conclude at approximately 3:30 p.m. Eastern time / 12:30 p.m. Pacific time / 9:30 p.m. Central European time. The presentations will be webcast live with slides and archived at www.celltherapeutics.com.

About Tosedostat

Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials.  CTI has exclusive marketing and co-development rights to Chroma Therapeutics Ltd.'s drug candidate tosedostat in North, Central and South America.

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 with particular specificity for CpG-rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone in an effort to prevent the binding of iron and perpetuation of superoxide production -- both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline-like potency in the treatment of relapsed/refractory diffuse large lymphoma without unacceptable rates of cardiotoxicity.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.

Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_alert.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone and tosedostat include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone and tosedostat in particular including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of NHL and/or other tumors as determined by the U.S. Food and Drug Administration (the "FDA") and/or the European Medicines Agency (the "EMA"), the potential failure of tosedostat to prove safe and effective for the treatment of AML, myelodysplastic syndromes, multiple myeloma, blood related cancers and solid tumors as determined by the FDA and/or the EMA, that the FDA may not accept the proposed clinical trial of tosedostat and/or may request additional trials, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials,  determinations by regulatory, patent, and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing, and selling pixantrone and tosedostat, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

 

 

Media Contact:

Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: deramian@ctiseattle.com
www.CellTherapeutics.com/press_room

Investors Contact:

Ed Bell
T: 206.282.7100
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors

Medical Information Contact:

T: 800.715.0944
E: info@askarm.com

 


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