Wow! Worse on efficacy AND safety! Probably calls the platform into question. The stock hasn't opened yet that I can see, but I expect less than $2 on this. Geez, how did no signal show up in prior trials? Good thing this is a small position for me . . .
>>Phase 3 Pivotal Trial of TOCOSOL(R) Paclitaxel Does Not Meet Primary Endpoint
Monday September 24, 7:36 am ET
BOTHELL, Wash.--(BUSINESS WIRE)--Sonus Pharmaceuticals, Inc. (NASDAQ:SNUS - News) today announced that its Phase 3 pivotal trial of TOCOSOL® Paclitaxel in women with metastatic breast cancer did not meet its primary endpoint of non-inferiority on objective response rate (ORR) when compared to the Taxol® control arm. Trial results showed the ORR for TOCOSOL Paclitaxel was 37% versus 45% for Taxol (p value = 0.085). The outcome of this trial does not support the submission of a New Drug Application.
With regard to the safety profile, the rates of neutropenia and febrile neutropenia in the TOCOSOL Paclitaxel arm were significantly higher than the Taxol arm, which may be related to the 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 the primary endpoint of this pivotal trial, particularly given the efficacy and safety results from previous clinical studies of our drug," said Michael A. Martino, President and Chief Executive Officer of Sonus. "Given these results, we expect Bayer Schering will exercise its right to terminate our agreement. In the coming weeks, Sonus will further evaluate the data and make decisions about the future of TOCOSOL Paclitaxel and other programs. Our primary goal remains to maximize shareholder value, and we are actively evaluating all alternative ways to achieve that goal."
"We would like to take this opportunity to thank the patients and investigators who have participated in the clinical development program for TOCOSOL Paclitaxel," added Mr. Martino.
Conference Call Information
Sonus will sponsor a conference call at 5:00 A.M. PT/8:00 A.M. ET today to discuss the Phase 3 results. The call will be web cast live and archived at www.sonuspharma.com/events.html. A telephone replay will be available on September 24 at 7:00 A.M. PT/10:00 A.M. ET for one week at 800-405-2236 or 303-590-3000 for international calls; Pass code: 11098211.<<
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Not even an attempt at subset analysis.
Sorry, Tuck |
