Cell Therapeutics Says Brown Uty. Study Reveals High Pathological Complete Response Rate for OPAXIO Treatment in Esophagus Cancer - Update

Wednesday, biopharmaceutical company Cell Therapeutics, Inc. (CTIC) said that, in a study released from Brown University at the 2009 American Society for Clinical Oncology Annual Meeting, patients with cancer of the lower esophagus had evidence of a high pathological complete response rate when given OPAXIO, a biologically enhanced paclitaxel, in addition to cisplatin and full-course radiotherapy.

OPAXIO, which was formerly known as XYOTAX, is the company's investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer, which results in a new chemical entity.

Pre-clinical 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.

The company revealed that in this study, which follows their earlier report of a phase IB trial, 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 and cisplatin 25mg/m2 for six weeks with concurrent 50.5Gy of radiation.

Concurrent chemotherapy with 50.5 Gy of radiation is the standard pre-surgical therapy for patients with potentially resectable, locally-advanced esophageal cancer.

Twenty-three patients were enrolled at the time of abstract submission. Five of the first 11 patients who underwent resection had a pathologic complete response.

The company said that they were 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.

Cell Therapeutics also said it plans to explore with the U.S. Food and Drug Administration 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 expected gastrointestinal and other severe toxicities.

CTIC is currently trading at $1.80 up $0.08, or 4.65% on a volume of 35.95 shares on the Nasdaq.

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