SNUS - Sonus Pharmaceuticals Inc.

[Klipper22]

Huge dropper on drug cancellation.

Sonus Pharmaceuticals (SNUS) said Monday that its cancer drug Tocosol paclitaxel failed a pivotal phase III study conducted in breast cancer patients.

The failed study effectively puts an end to the drug's development. Sonus said it will not be seeking FDA approval for the drug and expects its partnership with German drugmaker Bayer to be terminated.

Sonus closed Friday at $4.35 per share, but it plunged 85% to 66 cents when it opened for trading Monday morning.

Tocosol paclitaxel is a reformulation of the broadly used chemotherapy drug paclitaxel, which is known by its brand name Taxol. Sonus' proprietary drug delivery technology uses vitamin E to allow chemotherapy drugs to be administered much more easily, with less toxicity and fewer side effects. Superior efficacy was also a possibility.

But a phase III study of Tocosol paclitaxel in women with breast cancer came up well short of meeting any of those goals. The overall response rate in the Tocosol paclitaxel arm was 37%, compared with 45% in patients given conventional paclitaxel. This result was not only numerically inferior but also statistically inferior, which was the primary endpoint of the study.

Tocosol paclitaxel was also found to be inferior when it comes to safety, with patients on the drug reporting higher rates of neutropenia, or lowered white blood cell counts. There was also no statistically significant difference between Tocosol paclitaxel and conventional paclitaxel when it comes to neuropathy, a side effect affecting a patient's peripheral nerves that can cause tingling, numbness and pain.

On the basis of these data, Sonus and Bayer are closing all ongoing clinical trials involving Tocosol paclitaxel.

[elvis]

i'm wondering if this one will drop any lower next week. if so i'll be considering a position. 2nd time this came up on my scans..

last price is at .51




quick look at the chart you can see on the 24th it got pummled.

[Weirdharold]

Elvis, I did no DD on this do you know why the huge gap down? since that time the charts are really hard to predict That Gap messes everything up... right now I would simply say flipping a coin would probably be as accurate a way to decide this.... unless you know and understand the facts about what has been and what is going on.

sorry, not much help :mad:

[elvis]

yup, the last pr that came out this thing dropped like your pants would at your bachelor party :P

-------------------------------
Phase 3 Pivotal Trial of TOCOSOL(R) Paclitaxel Does Not Meet Primary Endpoint
BusinessWire - September 24, 2007 7:36 AM ET

Sonus Pharmaceuticals, Inc. (NASDAQ:SNUS) today announced that its Phase 3 pivotal trial of TOCOSOL(R) 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(R) 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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basically it's another company who's drug failed there "trial".

[Weirdharold]

I remember reading that..... they were partnered up with Bayer... who was financing the test and Bayer used the failure of the drug to perform to drop out because in their oppinion it would not be worth it to submit the drug for USDA approval.... Yeah that wold make a pharm company fall like that.

[elvis]

Sonus Pharma Engages Ferghana Partners As Strategic Advisor

Oct 22, 2007 17:08:08 (ET)


DOW JONES NEWSWIRES

Sonus Pharmaceuticals Inc. (SNUS) engaged Ferghana Partners Inc. as its strategic advisor to assist the company in identifying, evaluating and pursuing alternative strategies to increase shareholder value.

The Bothell, Wash., cancer-drug developer said it chose Ferghana for its concentration on firms in the biotechnology, pharmaceutical, diagnostic and specialty chemical industries.

Sonus shares rose 4 cents, or 3.8%, to $56 cents in recent trading.

-Jonathan Vuocolo; 201-938-5400; AskNewswires@dowjones.com

(END) Dow Jones Newswires

October 22, 2007 17:08 ET (21:08 GMT)

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looks to be good news, or a waste of money.

[Therion]

Man biotechs are hard plays... I had one of these in my retirement portfolio drop 50% in one day because their main drug did not get approval from the FDA. And you're right Harold, the gaps make TA pretty tough.