Sonus to acquire Taxol data

By Elaine Rigoli

Tampa, Fla., July 5 - Sonus Pharmaceuticals, Inc. has reached an agreement with the Cancer and Leukemia Group B Foundation (CALGB) to acquire rights to use data from the CALGB Study 9840, a phase 3 trial comparing weekly dosing of Taxol (paclitaxel injection) to three-weekly dosing of Taxol in patients with metastatic breast cancer.

Sonus said this data will support regulatory submissions for Tocosol Paclitaxel (paclitaxel injectable emulsion), the company's anticancer drug, in a phase 3 trial in patients with metastatic breast cancer comparing the safety and efficacy of Tocosol Paclitaxel administered weekly with Taxol administered weekly.

The Food and Drug Administration has indicated to Sonus that a New Drug Application approval will require either a demonstration of superior efficacy of Tocosol Paclitaxel compared to Taxol or a demonstration of non-inferior efficacy as compared to Taxol and either:

• A change of the approved label for Taxol to include a weekly dosing schedule; or

• Availability of reviewable data from a trial comparing the efficacy of Taxol using a weekly dosing schedule to that of Taxol using the currently approved three-weekly dosing schedule.

In the event that Tocosol Paclitaxel does not achieve superior efficacy over Taxol in the phase 3 trial or the approved label for Taxol is not changed to include a weekly dosing schedule, Sonus said it will submit the CALGB 9840 data to the FDA as part of the Tocosol Paclitaxel NDA to support weekly dosing of Taxol as a reference arm in the ongoing phase 3 trial.

Sonus is a pharmaceutical company based in Bothell, Wash.

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