Exhibit 99.1
CONTACT : Pamela L. Dull, Sonus Pharmaceuticals, (425)
487-9500, Ext. 255
Sonus
Pharmaceuticals Completes Special Protocol Assessment (SPA) Process with FDA
for TOCOSOL® Paclitaxel Phase 3 Clinical Trial in Breast Cancer
BOTHELL, Washington, July 7, 2005—Sonus
Pharmaceuticals, Inc. (Nasdaq:SNUS) today announced that the U.S. Food and
Drug Administration (FDA) has completed a Special Protocol Assessment (SPA) for
the pivotal Phase 3 trial of the Company’s lead cancer product candidate, TOCOSOL®
Paclitaxel. Final written communication
from the FDA, dated June 30 and received by the Company on July 5,
indicates that the FDA and Sonus have reached agreement on the protocol for the
planned Phase 3 study of TOCOSOL Paclitaxel and on the formal written plans for
how the study will be conducted. The
Phase 3 study will compare TOCOSOL Paclitaxel and Taxol® in the
treatment of patients with breast cancer.
In
the Phase 3 trial, approximately 800 patients will be randomly assigned to
treatment with either TOCOSOL Paclitaxel or Taxol, and the effects of each drug
on anti-tumor efficacy, tolerability and safety will be assessed. The study progress and interim data
evaluations will be overseen by an Independent Data Monitoring Committee
comprised of medical oncology and biostatistics experts not associated with the
Company.
“This
is a significant milestone that represents a tremendous amount of hard work on
the part of our entire team at Sonus,” said Michael A. Martino, President and
CEO of Sonus. “Our corporate development
efforts are now focused on securing the necessary financial resources to
support the study, and these efforts are ongoing on several fronts. In parallel, we have already begun study
start-up activities for the Phase 3 trial.”
“Negotiations with investigators and regulatory reviews by health
authorities are currently underway in multiple countries where the Phase 3 study
will be performed,” added Michael B. Stewart, M.D., Senior Vice President and
Chief Medical Officer. “We continue to believe that TOCOSOL Paclitaxel may one day
offer a new treatment option for cancer patients, and we are very eager to
initiate the Phase 3 trial to demonstrate the product’s clinical
value.”
More
The SPA process provides for official FDA evaluation and written
guidance on the design, size, and procedures for conducting a pivotal Phase 3
clinical trial and provides the sponsor with written agreement that the design
and analysis methods are adequate for a study that is intended to form the
basis for a New Drug Application.
About TOCOSOL
Paclitaxel
TOCOSOL
Paclitaxel is a novel, proprietary formulation of the leading anti-cancer drug
paclitaxel. TOCOSOL Paclitaxel
has been designed to overcome the limitations associated with Taxol and generic
paclitaxel-based chemotherapy, including long infusion times, undesirable or
treatment-limiting side effects as well as time consuming and expensive
preparation of the products prior to administration. TOCOSOL Paclitaxel has generated encouraging
data on safety and anti-tumor activity in Phase 2 trials in breast, ovarian,
non-small cell lung and bladder cancers.
About
Sonus Pharmaceuticals, Inc.
Headquartered near Seattle,
Washington, Sonus Pharmaceuticals, Inc. is focused on the development of
therapeutic drugs that may offer improved administration, safety, tolerability
and effectiveness for the treatment of cancer and related conditions. For additional information on Sonus,
including news releases, please visit www.sonuspharma.com.
Safe
Harbor
Certain statements made in this press release
are forward-looking such as those, among others, relating to the development,
safety and efficacy of drug delivery products and potential applications for
these products or the anticipated date of the initiation of Phase 3 clinical
trials for TOCOSOL Paclitaxel. As
discussed in Sonus Pharmaceuticals’ filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K filed on March 23,
2005, 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 initiate Phase 3 clinical trials for TOCOSOL Paclitaxel;
risks that clinical studies with TOCOSOL Paclitaxel will not be successful;
risks that the FDA may not approve the company’s proposed New Drug Application;
risks of successful development of additional drug delivery products; 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.
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Taxol® is a registered
trademark of Bristol-Myers Squibb Company.
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