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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

llo,Thomas et al, Am. J. Clin. Oncol. 4:376-9 (2006)), patients with pathologically confirmed, locally advanced adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-esophageal junction with no evidence of distant metastasis received weekly paclitaxel poliglumex (50mg/m2) and cisplatin 25mg/m2 for six weeks with concurrent 50.5Gy of radiation. Twenty-three eligible patients were enrolled at the time of abstract submission. Five of the first 11 patients (45%) who underwent resection had a pathologic complete response. A prophylactic feeding tube was not routinely used. Grade 3-4 toxicity in the first 15 patients included dehydration (n=5), loss of appetite (n=5), esophagitis/dysphagia (n=4), nausea (n=2) and weight loss (n=1). The authors concluded that these preliminary data suggest paclitaxel poliglumex may provide enhanced radiation sensitization as compared to standard therapy. Accrual is continuing on this study.

"We are very encouraged by these preliminary phase II results. Patients who have a pathologic CR in most historical studies have had a major survival advantage over those patients with lesser responses. These interesting preliminary findings in an ongoing study indicate that paclitaxel poliglumex may be a uniquely active and selective radiosensitizing therapeutic. Most importantly, patient tolerability appears improved over standard therapy with 5-FU and cisplatin due to the lower incidence of severe gastrointestinal toxicity. It is likely that this is due to the selective accumulation of paclitaxel poliglumex in tumor tissue with continual slow release of the active agent, paclitaxel," noted Jack Singer, M.D., Chief Medical Officer at CTI.

CTI plans to explore with the U.S. Food and Drug Administration (the "FDA") a potential U.S. phase III registration strategy for paclitaxel poliglumex in this indication given the high pathologic CR rates being reported in this study combined with the lower than expect
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SOURCE Cell Therapeutics, Inc.
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