At ASCO, Cell Therapeutics (CTIC) Said Study Shows OPAXIO Produces 45% Pathologic Complete Remissions in Patients With Esophageal Cancer

June 3, 2009 7:07 AM EDT

At ASCO, Cell Therapeutics, Inc. (Nasdaq: CTIC) said a study released from Brown University showed that patients with cancer of the lower esophagus had evidence of a high pathological complete response rate when given OPAXIO added to cisplatin and full-course radiotherapy.

Cell Therapeutics said OPAXIO produces 45% pathologic complete remissions in patients with esophageal cancer.

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 (Dipetrillo,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.

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