Healthcare Industry News: paclitaxel
News Release - November 16, 2006
Sonus Pharmaceuticals Announces Completion of Patient Enrollment in Phase 3 Pivotal Trial of TOCOSOL(R) Paclitaxel in Metastatic Breast CancerBOTHELL, Wash.--(HSMN NewsFeed)--Sonus Pharmaceuticals, Inc. (NASDAQ: SNUS ) today announced that it has completed enrollment in the Phase 3 pivotal trial of its lead oncology product candidate, TOCOSOLŽ paclitaxel, in women with metastatic breast cancer. Formulated with the Company's proprietary vitamin E-based emulsion TOCOSOL technology, TOCOSOL paclitaxel is a new formulation of the widely prescribed anti-cancer drug, paclitaxel, which is a member of the taxane group of chemotherapy drugs. Sonus expects data from the TOCOSOL paclitaxel Phase 3 trial to be available in the third quarter of 2007, with submission of a New Drug Application (NDA) targeted for the end of 2007.
The Phase 3 trial is being conducted at clinical study sites in North America, Western and Eastern Europe, South Africa and Israel. Patients in the trial were randomized to receive either TOCOSOL paclitaxel or TaxolŽ on a weekly dosing schedule. The primary endpoint for the Phase 3 study is objective response rate, and the NDA will be submitted based on analyses of data for that endpoint. Secondary endpoints include progression-free survival and overall survival. The trial is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration.
"We are pleased to have completed enrollment in the Phase 3 study in just over a year, and we gratefully acknowledge the patients and investigators who participated in the study for their role in helping to evaluate TOCOSOL paclitaxel," said Michael A. Martino, President and Chief Executive Officer of Sonus Pharmaceuticals. "In reaching this important milestone in the pivotal trial of TOCOSOL paclitaxel, we are one step closer to introducing an innovative product that could potentially improve the treatment and therapeutic outcomes of cancer patients treated with taxane-based therapies."
About Sonus Pharmaceuticals
Located near Seattle, Sonus Pharmaceuticals is focused on the development of drugs that provide better therapeutic alternatives for cancer patients, including improved efficacy, safety and tolerability, and are more convenient to use. The Company's lead oncology product candidate, TOCOSOL paclitaxel, is currently in a Phase 3 pivotal trial for the potential treatment of metastatic breast cancer. In October 2005, Sonus entered into a partnership agreement with Schering AG, Germany for the development and commercialization of TOCOSOL paclitaxel. In addition to the continued progress with TOCOSOL paclitaxel, the Company moved its second product candidate, TOCOSOL Camptothecin, into Phase 1 clinical development in September 2006. TOCOSOL Camptothecin is a new entry in the same drug class as the approved camptothecin analogs, irinotecan and topotecan. Preclinical data suggest that TOCOSOL Camptothecin may be more efficacious and better tolerated than irinotecan. For additional information on Sonus, including news releases, please visit www.sonuspharma.com.
Certain statements made in this press release are forward-looking such as those, among others, relating to the development, safety and efficacy of therapeutic drugs 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 for 2005 and Quarterly Report on Form 10-Q for the third quarter of 2006, 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 be delayed or will not be successful; risks that the FDA may not approve the TOCOSOL paclitaxel New Drug Application; risks that the Phase 1 clinical trial for TOCOSOL Camptothecin will not be successful; risks of successful development of therapeutic drugs; 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.
TaxolŽ is a registered trademark of Bristol-Myers Squibb Company.
Source: Sonus Pharmaceuticals
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