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Paclitaxel Poliglumex (OPAXIO(TM)) Added to Cisplatin and Radiation Produces 45% Pathologic Complete Remissions in Patients With Esophageal Cancer
Date:6/2/2009

Promising Preliminary Results on Radiation Sensitization from Phase II Trial May Serve as Additional Registration Direction for OPAXIO

ORLANDO, Fla., June 3 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that, in a study released from Brown University at the 2009 American Society for Clinical Oncology (ASCO) Annual Meeting, patients with cancer of the lower esophagus had evidence of a high pathological complete response ("CR") rate when given OPAXIO, a biologically enhanced paclitaxel, in addition to cisplatin and full-course radiotherapy.

Concurrent chemotherapy with 50.5 Gy of radiation is the standard pre-surgical therapy for patients with potentially resectable, locally-advanced esophageal cancer. Although the addition of chemotherapy to radiation is beneficial, the cure rate for esophageal cancer is low. Standard neoadjuvant treatment for esophageal cancer uses a regimen of cisplatin, and fluorouracil (5-FU) chemotherapy with concurrent radiation, a regimen associated with a 15% to 17% pathologic CR rate (complete elimination of the cancer in the surgical specimen) and a high incidence of Grade 3-4 toxicity to the upper gastrointestinal track necessitating prophylactic insertion of feeding tubes. Published preclinical studies have demonstrated that, unlike standard paclitaxel and other chemotherapeutic agents that enhance radiation killing by a factor of 1.5 to 2.0, OPAXIO increases tumor specific radiation cell kill by a factor of 7.2 to 8.4 -fold (Milas Luka et al, Poly(L-glutamic acid)-paclitaxel conjugate is a potent enhancer of tumor radiocurability, Int'l J. Radiat. Oncol. Biol. Phys. 55(3), 707-12 (2003)).

The Brown University Oncology Group lead by Dr. Howard Safran published preliminary data on their phase II trial in the ASCO proceedings. In this study, which follows their earlier report of a phase IB trial (Dipetri
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SOURCE Cell Therapeutics, Inc.
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