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Phase 3 Pivotal Trial of TOCOSOL(R) Paclitaxel Does Not Meet Primary Endpoint |
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25 Sep 2007 |
Sonus Pharmaceuticals, Inc. today announced that its Phase 3 pivotal trial of TOCOSOL® Paclitaxel in women withmetastatic breast cancer did not meet its primary endpoint of non-inferiority on objectiveresponse rate (ORR) when compared to the Taxol® control arm
BOTHEL, WA, USA | September 24, 2007 | Sonus Pharmaceuticals, Inc. (NASDAQ: SNUS)today announced that its Phase 3 pivotal trial of TOCOSOL® Paclitaxel in women withmetastatic breast cancer did not meet its primary endpoint of non-inferiority on objectiveresponse rate (ORR) when compared to the Taxol® control arm. Trial results showed the ORRfor TOCOSOL Paclitaxel was 37% versus 45% for Taxol (p value = 0.085). The outcome of thistrial does not support the submission of a New Drug Application.
With regard to the safety profile, the rates of neutropenia and febrile neutropenia in theTOCOSOL Paclitaxel arm were significantly higher than the Taxol arm, which may be related tothe higher dose of TOCOSOL Paclitaxel used in the Phase 3 trial compared to Taxol.Additionally, the study results did not demonstrate the expected benefit in peripheral neuropathy,which was not statistically different between the two arms.Based on a risk/benefit analysis of these results, Sonus and Bayer Schering Pharma AG,Germany are closing all clinical trials of TOCOSOL Paclitaxel, including the Phase 3 study.
“We are profoundly surprised and disappointed that TOCOSOL Paclitaxel did not achieve theprimary endpoint of this pivotal trial, particularly given the efficacy and safety results fromprevious clinical studies of our drug,” said Michael A. Martino, President and Chief ExecutiveOfficer of Sonus. “Given these results, we expect Bayer Schering will exercise its right toterminate our agreement. In the coming weeks, Sonus will further evaluate the data and makedecisions about the future of TOCOSOL Paclitaxel and other programs. Our primary goalremains to maximize shareholder value, and we are actively evaluating all alternative ways toachieve that goal.”
“We would like to take this opportunity to thank the patients and investigators who haveparticipated in the clinical development program for TOCOSOL Paclitaxel,” added Mr. Martino.Conference Call InformationSonus will sponsor a conference call at 5:00 A.M. PT/8:00 A.M. ET today to discuss the Phase 3results. The call will be web cast live and archived at www.sonuspharma.com/events.html.
About Sonus PharmaceuticalsHeadquartered near Seattle, Washington, Sonus Pharmaceuticals, Inc. is focused on thedevelopment of cancer drugs that are designed to provide better efficacy, safety and tolerability,and are more convenient to use. Sonus moved its second oncology product candidate,TOCOSOL Camptothecin, into a Phase 1 clinical trial in September 2006. For additionalinformation on Sonus, including past news releases, please visit www.sonuspharma.com.Sonus Pharmaceuticals Safe HarborCertain statements made in this press release are forward-looking such as those, among others,relating to the Company’s further evaluation of programs related to its therapeutic drugs andpotential applications for these products. As discussed in Sonus Pharmaceuticals' filings with theSecurities and Exchange Commission, including its Annual Report on Form 10-K for 2006 andsubsequent Quarterly Reports on Form 10-Q, actual results could differ materially from thoseprojected in the forward-looking statements as a result of the following factors, among others:the Company's products will require continued pre-clinical evaluation and clinical testing andapproval by regulatory authorities; such activities are lengthy and expensive and may never besuccessful; risks that the Phase 1 clinical trial for TOCOSOL Camptothecin will not besuccessful; and risks that the Company may not be successful in obtaining funding from thirdparties or completing a financing necessary to support the costs and expenses of other clinicalstudies as well as research and development activities. The Company undertakes no obligationto update the forward-looking statements contained herein or to reflect events or circumstancesoccurring after the date hereof.
SOURCE: Sonus Pharmaceuticals, Inc |
