Sonus' Tocosol Paclitaxel shows 53% response rate in phase 2 cancer study

By Angela McDaniels

Seattle, Nov. 8 - Sonus Pharmaceuticals Inc. said Tocosol Paclitaxel showed promising anti-tumor activity in an ongoing phase 2 clinical trial of 47 women with first-line metastatic breast cancer.

"The phase 2 study ... is demonstrating an investigator-reported confirmed objective response rate of 53% and an independent radiologist-reported confirmed objective response rate of 49%," said Michael B. Stewart, senior vice president and chief medical officer, in a company news release.

"These data are compelling as they are at the upper end of published objective response rates for weekly taxane therapy in metastatic breast cancer. In addition, the agreement between investigator-reported responses and the independent radiologist-reported responses supports the robustness of the study conduct."

Patients received weekly doses of Tocosol Paclitaxel of 100 or 120 mg/m for 16 weeks. The drug appears to be well tolerated, the company said.

The data was presented Thursday at the San Antonio Breast Cancer Symposium.

Based on the results of the Phase 2 program to date, which include studies in metastatic breast, non-small cell lung, bladder and ovarian cancers, a multinational phase 3 pivotal study of Tocosol Paclitaxel for the potential treatment of metastatic breast cancer was initiated in September.

The phase 3 study is being conducted under a Special Protocol Assessment from the U.S. Food and Drug Administration, the company said.

Schering AG of Germany licensed exclusive worldwide development and commercialization rights to Tocosol Paclitaxel from Sonus in October.

Under the agreement, Schering will be responsible for the worldwide marketing and distribution of Tocosol Paclitaxel. If approved, the product will be marketed in the United States by Berlex Oncology, a unit of Schering group member Berlex Inc.

Tocosol Paclitaxel is an injectable, ready-to-use formulation of the widely prescribed anti-cancer drug paclitaxel. Paclitaxel is a member of the taxane group of chemotherapy drugs and is the active ingredient in approved drug products that are used to treat many forms of cancer.

Headquartered near Seattle, Sonus Pharmaceuticals is focused on the development of novel drugs that provide better therapeutic alternatives for cancer patients, including improved safety, tolerability and efficacy and more convenient administration.

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