• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Sonus Pharmaceuticals to Release Second Quarter Financial Results and Hold Quarterly Conference Call on August 8

Posted on: Wednesday, 20 July 2005, 18:01 CDT

Sonus Pharmaceuticals, Inc. (Nasdaq:SNUS) today announced that it will release second quarter financial results and provide a company update during its quarterly conference call on Monday, August 8. During the conference call, the Company will discuss progress on strategic objectives, including the clinical and regulatory initiatives for TOCOSOL(R) Paclitaxel, Sonus' lead cancer product candidate. The Company recently announced that the U.S. Food and Drug Administration had completed a Special Protocol Assessment (SPA) for a single pivotal Phase 3 trial of TOCOSOL Paclitaxel in breast cancer. Sonus is planning to begin enrollment of patients in the Phase 3 study by end of third quarter 2005.

The Phase 3 trial compares TOCOSOL Paclitaxel and Taxol(R) administered weekly in the first- and second-line treatment of metastatic breast cancer. Approximately 800 evaluable patients will be enrolled over six to nine months, with equal numbers of patients randomly assigned to the two treatment arms. Study sites in North America, the European Union, Eastern Europe, Israel and South Africa are expected to participate. The study's primary endpoint is objective response rate. Objective responses will be confirmed by independent radiologists. The primary analysis will be for non-inferiority, and if the primary analysis is statistically significant, data will be analyzed for superiority. Secondary endpoints are progression-free survival and overall survival. The initial New Drug Application for TOCOSOL Paclitaxel would be submitted on the basis of objective response data. A Data Monitoring Committee will oversee the interpretation of efficacy and safety data from the Phase 3 trial.

Conference Call Information

The second quarter conference call will be web cast live on August 8, 2005, at 1:30 Pacific time/4:30 P.M. Eastern time and can be accessed at www.sonuspharma.com/events.html. An archive of the call will be available through the same link. A telephone replay will be available from August 8, 4:30 P.M. Pacific time/7:30 P.M. Eastern time, for one week at 800-642-1687 or 706-645-9291 for international calls; Conference ID 7868773.

About TOCOSOL Paclitaxel

TOCOSOL Paclitaxel is a novel, proprietary formulation of the leading anti-cancer drug paclitaxel. TOCOSOL Paclitaxel has been designed to overcome the limitations associated with Taxol and generic paclitaxel-based chemotherapy, including long infusion times, undesirable or treatment-limiting side effects as well as time consuming and expensive preparation of the products prior to administration. TOCOSOL Paclitaxel has generated encouraging data on safety and anti-tumor activity in Phase 2 trials in breast, ovarian, non-small cell lung and bladder cancers.

About Sonus Pharmaceuticals, Inc.

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 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 or the anticipated date of the initiation of Phase 3 clinical trials for TOCOSOL Paclitaxel. 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, 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 initiate Phase 3 clinical trials 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

More News in this Category