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Sonus Pharmaceuticals Initiates Pivotal Phase 3 Trial of TOCOSOL(R) Paclitaxel for Treatment of Metastatic Breast Cancer

Posted on: Wednesday, 28 September 2005, 15:01 CDT

Sonus Pharmaceuticals, Inc. (NASDAQ:SNUS) today announced the initiation of the pivotal Phase 3 trial of TOCOSOL(R) Paclitaxel that is intended to serve as the basis for approval of the product by the U.S. Food and Drug Administration (FDA). The two-arm, randomized study is being conducted under a Special Protocol Assessment (SPA) that Sonus completed with the FDA in June 2005. The trial will enroll approximately 800 women with metastatic breast cancer, who will receive either TOCOSOL Paclitaxel or Taxol(R) on a weekly dosing schedule.

The Phase 3 study's primary endpoint is objective response rate (ORR), and the New Drug Application (NDA) will be submitted based on analyses of data for that endpoint. Secondary endpoints of progression-free survival and overall survival are included in the trial design, and patient follow-up for those endpoints will continue following NDA submission. The Phase 3 trial will be conducted at approximately 150 clinical study sites in North America, Western and Eastern Europe, South Africa and Israel. The Company is anticipating that patient enrollment in the trial will be completed during the summer of 2006.

"Initiation of this Phase 3 trial is an important milestone towards achieving our goal of commercializing an innovative approach to taxane-based chemotherapy," said Michael A. Martino, president and chief executive officer. "We continue to be highly encouraged by the findings of our previous clinical studies, which suggest that TOCOSOL Paclitaxel may be an active anti-cancer agent that is well tolerated on a weekly basis. With the Phase 3 trial, we are optimistic that our novel TOCOSOL Paclitaxel product may be proven to be a better therapeutic alternative for women with metastatic breast cancer."

TOCOSOL Paclitaxel is a vitamin E-based emulsion formulation that allows a dose of paclitaxel to be infused over 15 minutes, and TOCOSOL Paclitaxel has been shown clinically to deliver substantially more active paclitaxel than can be achieved with Taxol. TOCOSOL Paclitaxel offers the convenience of a ready-to-use formulation that does not require preparation prior to administration, as required with marketed taxane products. Sonus has completed patient enrollment in Phase 2a studies of TOCOSOL Paclitaxel in non-small cell lung, ovarian and bladder cancers and has ongoing Phase 2b studies in breast and bladder cancers.

About Sonus Pharmaceuticals

Headquartered near Seattle, Washington, Sonus Pharmaceuticals, Inc. is focused on the development of therapeutic drugs that may offer improved administration, safety, tolerability and effectiveness for the treatment of cancer and related conditions. For additional information on Sonus, including past news releases, please visit www.sonuspharma.com.

Safe Harbor

Certain statements made in this press release are forward-looking such as those, among others, relating to the development, safety and efficacy of drug delivery products and potential applications for these products. As discussed in Sonus Pharmaceuticals' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K filed on March 23, 2005 and Form 10-Qs for the first two quarters of 2005, actual results could differ materially from those projected in the forward-looking statements as a result of the following factors, among others: the Company's products will require extensive clinical testing and approval by regulatory authorities; such approvals are lengthy and expensive and may never occur; risks that the Company will not be able to complete the Phase 3 clinical trial for TOCOSOL Paclitaxel; risks that clinical studies with TOCOSOL Paclitaxel will not be successful; risks that the FDA may not approve the Company's proposed New Drug Application; risks of successful development of additional drug delivery products; and risks that the Company may not be successful in obtaining funding from third parties or completing a financing necessary to support the costs and expenses of clinical studies as well as research and development activities. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof.

Source: Business Wire

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