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High Rates of Pathological Complete Response in Patients with Advanced Esophageal Cancer in OPAXIO™ Phase II Study Reported in American Journal of Clinical Oncology
Date:2/23/2011

that of the 37 patients who underwent surgery, 12 patients achieved a pathologic complete response.  Additionally, three patients achieved a complete clinical endoscopic response and refused surgery.  Importantly, only one patient required a feeding tube and one patient used total parenteral nutrition. There were no grade 4 hematologic adverse events. Grade 3 hematologic adverse events included neutropenia (6%) and grade 3 non-hematologic toxicities included nausea (7%), esophagitis (7%), and fatigue (5%).

"This phase II study with OPAXIO demonstrated an encouragingly high rate of complete disappearance of cancer in patients that underwent potentially curative surgery following chemoradiotherapy.  Moreover, the therapy had a low incidence of the severe inflammation of the esophagus that frequently requires a feeding tube observed with the current standard regimens," said Jack Singer, M.D., Chief Medical Officer of CTI. "We believe that this study provides preliminary clinical support to our belief that paclitaxel poliglumex is a potent and tumor-selective radiosensitizer."

About OPAXIO™OPAXIO™ (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX™, is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard pac
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SOURCE Cell Therapeutics, Inc.
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