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news.Sonus Pharmaceuticals has completed enrollment in the phase III trial of its oncology product candidate, Tocosol Paclitaxel, in women with metastatic breast cancer.
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Formulated with the company’s vitamin E-based emulsion Tocosol technology, Tocosol Paclitaxel is a new formulation of the widely prescribed anticancer drug, paclitaxel, which is a member of the taxane group of chemotherapy drugs.
Sonus expects data from the Tocosol Paclitaxel phase III trial to be available in the third quarter of 2007, with submission of a new drug application targeted for the end of 2007.
The primary endpoint for the phase III study is objective response rate. Secondary endpoints include progression-free survival and overall survival. The trial is being conducted under a special protocol assessment with the FDA.
“In reaching this important milestone in the pivotal trial of Tocosol Paclitaxel, we are one step closer to introducing an innovative product that could potentially improve the treatment and therapeutic outcomes of cancer patients treated with taxane-based therapies,” said Michael Martino, president and CEO of Sonus Pharmaceuticals.