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Title: Paclitaxel Emulsion Formulation Allows for Quicker Dosing: Presented at AACR

"Paclitaxel Emulsion Formulation Allows for Quicker Dosing: Presented at AACR"

By Brian Reid WASHINGTON, DC -- July 14, 2003 -- A formulation of paclitaxel that encases the drug in a vitamin-E based emulsion appears to be easier to administer than the current formulation of paclitaxel and may cut the chance of adverse reactions to the drug. Researchers presented the findings here July 12th at the 94th Annual Meeting of the American Association for Cancer Research. The results of a phase IIa study from Sonus Pharmaceuticals, Bothell, Washington, United States, found that the drug was well tolerated when given in weekly 15-minute infusions to taxane-naive patients with ovarian, non-small cell lung (NSCL), bladder, and colorectal cancer. Existing paclitaxel-based products are given every 3 weeks, but that infusion takes 3 hours. "The major thing is that you can clearly give this drug over 15 minutes," said Paul Weiden, MD, director of clinical oncology at Sonus Pharmaceuticals. "It makes a big difference to patients if they're in the chair for 15 minutes instead of 3 hours." The open-label study is following patients with stage IV disease who are given the drug as monotherapy following 1 prior regimen of non-taxane chemotherapy. The study is testing 3 doses of the drug: 80 mg/m2, 100 mg/m2, and 120 mg/m2. The researchers have efficacy results on 126 patients who have had follow-up computed tomography scans evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and Dr. Weiden said the effectiveness appears similar to that seen with traditional paclitaxel preparations. Patients with ovarian cancer showed an objective response in 25% of cases, with responses of 21% in NSCL cancer patients, 33% in bladder cancer patients, and 4% in colorectal cancer patients. "Our initial thrust is that it's similar to other taxanes," Dr. Weiden said. Infusion reactions were uncommon, with 83.3% of patients reporting no symptoms, and no patients showed grade 4 infusion reactions. About 15% of patients did have grade 4 neutropenia and 1% reported grade 4 anemia. A new round of company-sponsored research is expected later this year, with a Food and Drug Administration filing expected in late 2005 or early 2006. [Study title: TOCOSOL Paclitaxel (Vitamin E Paclitaxel Emulsion): Multicenter Phase 2A Studies with Weekly Dosing in Non-Small Cell Lung, Bladder, Ovarian, and Colorectal Cancers. Abstract R3665]

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