RE: Paclitaxel
Sonus Pharmaceuticals Lead Cancer Product -- TOCOSOL Paclitaxel -- Shows Excellent Safety and Efficacy in Interim Phase 2 Clinical Study Results
Anti-Tumor Activity Demonstrated in All Studies
Wednesday September 18, 7:36 am ET
BOTHELL, Wash.--(BUSINESS WIRE)--Sept. 18, 2002-- Sonus Pharmaceuticals, Inc. (Nasdaq:SNUS - News) today reported initial efficacy results for TOCOSOL(TM) Paclitaxel from the dose escalation stage of four Phase 2 clinical studies in non small cell lung, bladder, ovarian and colorectal cancers.
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The results to date demonstrate objective anti-tumor responses in all four cancers and a disease control rate ranging from 37% to 89%. Sonus will present these Phase 2 results at the RedChip(TM) Investors Conference on Thursday, September 19, in New York City. TOCOSOL Paclitaxel is a proprietary formulation of paclitaxel, the active ingredient in the leading cancer drug Taxol®.
"We have made significant progress since initiating the Phase 2 program for TOCOSOL Paclitaxel in late March of this year, and we are very excited about the preliminary results," said Michael A. Martino, President and Chief Executive Officer of Sonus Pharmaceuticals. "To date, 73 patients from the dose escalation stage of the Phase 2 studies are evaluable for efficacy, including 18 in each of the non small cell lung, bladder and colorectal studies and 19 patients in the ovarian study. I am very pleased to report that initial results demonstrate a disease control rate (partial responses plus stable disease) of 78% in non small cell lung cancer, 89% in bladder cancer, 37% in ovarian cancer and 39% in colorectal cancer.
"These efficacy results include anti-tumor activity at all of the dosing levels studied in the dose escalation stage from 80 mg/m2 to 120 mg/m2. I am pleased to report that we have completed the dose escalation stage for the Phase 2 studies, and the weekly maximum tolerated dose determined for TOCOSOL Paclitaxel is 120 mg/m2 in the non small cell lung, ovarian and colorectal studies and 100 mg/m2 in the bladder study. These weekly dose levels correspond to a range of 300 mg/m2 to 360 mg/m2 over a three-week period, which is nearly twice the approved dose of Taxol given at 175 mg/m2 once every three weeks. Even at these higher dose levels, TOCOSOL Paclitaxel has demonstrated significantly lower incidences of neuropathy and neutropenia compared to those rates described in the Taxol package insert. The Phase 2 results to date show that the level of neuropathy for TOCOSOL Paclitaxel is 75% less than Taxol, and the neutropenia level is 66% less.
"We are very encouraged by the initial Phase 2 data for TOCOSOL Paclitaxel, which continues to build upon the solid results achieved in our Phase 1 study. Our objective is to further demonstrate outstanding safety and efficacy results for TOCOSOL Paclitaxel by continuing to aggressively enroll patients in all four of the ongoing Phase 2 studies and accelerating the initiation of additional clinical studies."
Initial Phase 2 Efficacy Data:
Non Small Cell Lung Cancer:
A disease control rate of 78% was achieved in 18 evaluable patients, including 22% partial responses (tumor area reduction greater than 50%) and 56% stable disease (halting of disease progression). The majority of patients in the non small cell lung study were Stage IV, meaning they had metastatic disease, and all had failed prior chemotherapy.
Bladder Cancer:
An 89% disease control rate has been demonstrated in 18 evaluable patients, which includes 17% partial responses and 72% stable disease. All patients with bladder cancer had locally advanced, recurrent or metastatic disease, and had failed prior platinum treatment. None of the bladder cancer patients have had disease progression while being treated with TOCOSOL Paclitaxel.
Ovarian Cancer:
The disease control rate in 19 evaluable patients was 37% (16% partial responses, 21% stable disease). All patients were platinum refractory/resistant, meaning that they progressed while on or within six months of therapy with a platinum agent. These patients were also in the later stage of disease, Stage III or IV. These types of ovarian cancer patients are the most difficult to treat.
Colorectal Cancer:
The disease control rate in 18 evaluable patients was 39%, including 6% partial responses and a stable disease rate of 33%. All patients in the colorectal study were in the advanced stages of disease.
About TOCOSOL Paclitaxel
Formulated with Sonus' proprietary TOCOSOL drug delivery technology, TOCOSOL Paclitaxel may provide administration benefits, reduced side effects and better efficacy. The Phase 1 clinical study for TOCOSOL Paclitaxel was completed in May 2002. Encouraging Phase 1 results indicated that TOCOSOL Paclitaxel can be administered in 15 minutes or less compared to the three-hour infusion required with Taxol. Phase 1 results also demonstrated disease control in 15 out of 36 patients (42%).
About Sonus Pharmaceuticals, Inc.
Located near Seattle, Washington, Sonus Pharmaceuticals is applying its expertise in drug delivery to make therapeutic drugs safer, easier to administer and more effective. In addition to TOCOSOL Paclitaxel, the Company is developing a number of other potential product candidates incorporating the TOCOSOL technology in applications to treat cancer, cardiovascular disease, diabetes and infection. Sonus news releases and other corporate information are available on the Company's web site at www.sonuspharma.com.
Certain of the statements made in this press release are forward-looking such as those, among others, relating to the development of drug delivery products and potential applications for these products. As discussed in the Sonus Pharmaceuticals Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2002, 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, and may be subject to certain other regulatory requirements; there can be no assurance that Sonus will be successful in its efforts to develop drug delivery products; there can be no assurance that Phase 1 and Phase 2 studies with TOCOSOL Paclitaxel will be successful or that increased efficacy will result from Sonus' emulsion-based formulations; the Company's results from operations have varied and will continue to vary from quarter to quarter and will depend upon, among other factors, timing and cost of clinical trials planned by Sonus and receipt of collaborative partner payments, if any; there can be no assurance that the Company will receive any future collaborative partner payments or that its cash requirements will be met by any such payments; and Sonus may seek external financing through available means, which may include debt and/or equity financing or the licensing or sale of proprietary or marketing rights, and there can be no assurance that financing will be available on acceptable terms, if at all.
Taxol(TM) is a registered trademark of Bristol-Myers Squibb Company.
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Contact:
Sonus Pharmaceuticals
Pamela L. Dull, 425/487-9500
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Source: Sonus Pharmaceuticals
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