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OPAXIO Produces High Rates of Pathologic Complete Remission in Patients with Advanced Esophageal Cancer; Study Paves Way for Potential Registration Trial as Radiation Sensitizer
Date:9/30/2009

PHILADELPHIA, Oct. 1 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that, in a study from Brown University to be presented by Howard Safran, M.D., head of the Brown University Oncology Group, in the proffered oral session at the Annual Meeting of the International Society of Gastrointestinal Oncology (ISGIO) in Philadelphia, Pennsylvania patients with cancer of the lower esophagus demonstrated a high rate of complete remission (CR) when given OPAXIO(TM) (paclitaxel poliglumex), a biologically enhanced paclitaxel, when administered in combination with standard cisplatin and concurrent radiation.

The phase II study, led by Dr. Safran, enrolled 40 patients with pathologically-confirmed, locally-advanced adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-esophageal junction with no evidence of distant metastasis. The patients received weekly paclitaxel poliglumex (50mg/m2) and cisplatin 25mg/m2 for six weeks with concurrent 50.5Gy of radiation. Of the first 28 patients undergoing surgery, all with adenocarcinoma, eight of 28 (28.5%), have achieved a pathologic CR. No patients required a feeding tube, in contrast to historical studies using the standard regimen where the large majority of patients require a feeding tube. There were no grade 4 hematologic toxicities; grade 3 hematologic toxicity included neutropenia (n=2) and anemia (n=1). Four of 35 patients experienced grade 4 non-hematologic toxicities, which included electrolyte abnormalities, glucose intolerance, hypersensitivity reaction and thromboembolus. Eleven of 35 patients had grade 3 non-hematologic toxicities including electrolyte abnormalities (n=5), nausea (n=3), dysphagia (n=2), fatigue (n=2), glucose intolerance (n=2), and hypersensitivity reaction (n=1). Grade 3 anorexia was reported in only one patient who subsequently was given total parenteral nutrition. No patients developed neuropathy.

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SOURCE Cell Therapeutics, Inc.
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