Sonus Pharmaceuticals Announces Completion of Patient Enrollment in Phase 3 Pivotal Trial of TOCOSOL(R) Paclitaxel in Metastatic
16 Noviembre 2006 - 7:30AM
Business Wire
Sonus Pharmaceuticals, Inc. (NASDAQ: SNUS) today announced that it
has completed enrollment in the Phase 3 pivotal trial of its lead
oncology product candidate, TOCOSOL� Paclitaxel, in women with
metastatic breast cancer. Formulated with the Company�s proprietary
vitamin E-based emulsion TOCOSOL technology, TOCOSOL Paclitaxel is
a new formulation of the widely prescribed anti-cancer drug,
paclitaxel, which is a member of the taxane group of chemotherapy
drugs. Sonus expects data from the TOCOSOL Paclitaxel Phase 3 trial
to be available in the third quarter of 2007, with submission of a
New Drug Application (NDA) targeted for the end of 2007. The Phase
3 trial is being conducted at clinical study sites in North
America, Western and Eastern Europe, South Africa and Israel.
Patients in the trial were randomized to receive either TOCOSOL
Paclitaxel or Taxol� on a weekly dosing schedule. The primary
endpoint for the Phase 3 study is objective response rate, and the
NDA will be submitted based on analyses of data for that endpoint.
Secondary endpoints include progression-free survival and overall
survival. The trial is being conducted under a Special Protocol
Assessment with the U.S. Food and Drug Administration. �We are
pleased to have completed enrollment in the Phase 3 study in just
over a year, and we gratefully acknowledge the patients and
investigators who participated in the study for their role in
helping to evaluate TOCOSOL Paclitaxel,� said Michael A. Martino,
President and Chief Executive Officer of Sonus Pharmaceuticals. �In
reaching this important milestone in the pivotal trial of TOCOSOL
Paclitaxel, we are one step closer to introducing an innovative
product that could potentially improve the treatment and
therapeutic outcomes of cancer patients treated with taxane-based
therapies.� About Sonus Pharmaceuticals Located near Seattle, Sonus
Pharmaceuticals is focused on the development of drugs that provide
better therapeutic alternatives for cancer patients, including
improved efficacy, safety and tolerability, and are more convenient
to use. The Company�s lead oncology product candidate, TOCOSOL
Paclitaxel, is currently in a Phase 3 pivotal trial for the
potential treatment of metastatic breast cancer. In October 2005,
Sonus entered into a partnership agreement with Schering AG,
Germany for the development and commercialization of TOCOSOL
Paclitaxel. In addition to the continued progress with TOCOSOL
Paclitaxel, the Company moved its second product candidate, TOCOSOL
Camptothecin, into Phase 1 clinical development in September 2006.
TOCOSOL Camptothecin is a new entry in the same drug class as the
approved camptothecin analogs, irinotecan and topotecan.
Preclinical data suggest that TOCOSOL Camptothecin may be more
efficacious and better tolerated than irinotecan. 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 therapeutic
drugs and potential applications for these products. As discussed
in Sonus Pharmaceuticals� filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for 2005 and
Quarterly Report on Form 10-Q for the third quarter of 2006, 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 complete the Phase 3 clinical trial
for TOCOSOL Paclitaxel; risks that clinical studies with TOCOSOL
Paclitaxel will be delayed or will not be successful; risks that
the FDA may not approve the TOCOSOL Paclitaxel New Drug
Application; risks that the Phase 1 clinical trial for TOCOSOL
Camptothecin will not be successful; risks of successful
development of therapeutic drugs; 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. Taxol(R) is a registered trademark
of Bristol-Myers Squibb Company. Sonus Pharmaceuticals, Inc.
(NASDAQ: SNUS) today announced that it has completed enrollment in
the Phase 3 pivotal trial of its lead oncology product candidate,
TOCOSOL(R) Paclitaxel, in women with metastatic breast cancer.
Formulated with the Company's proprietary vitamin E-based emulsion
TOCOSOL technology, TOCOSOL Paclitaxel is a new formulation of the
widely prescribed anti-cancer drug, paclitaxel, which is a member
of the taxane group of chemotherapy drugs. Sonus expects data from
the TOCOSOL Paclitaxel Phase 3 trial to be available in the third
quarter of 2007, with submission of a New Drug Application (NDA)
targeted for the end of 2007. The Phase 3 trial is being conducted
at clinical study sites in North America, Western and Eastern
Europe, South Africa and Israel. Patients in the trial were
randomized to receive either TOCOSOL Paclitaxel or Taxol(R) on a
weekly dosing schedule. The primary endpoint for the Phase 3 study
is objective response rate, and the NDA will be submitted based on
analyses of data for that endpoint. Secondary endpoints include
progression-free survival and overall survival. The trial is being
conducted under a Special Protocol Assessment with the U.S. Food
and Drug Administration. "We are pleased to have completed
enrollment in the Phase 3 study in just over a year, and we
gratefully acknowledge the patients and investigators who
participated in the study for their role in helping to evaluate
TOCOSOL Paclitaxel," said Michael A. Martino, President and Chief
Executive Officer of Sonus Pharmaceuticals. "In reaching this
important milestone in the pivotal trial of TOCOSOL Paclitaxel, we
are one step closer to introducing an innovative product that could
potentially improve the treatment and therapeutic outcomes of
cancer patients treated with taxane-based therapies." About Sonus
Pharmaceuticals Located near Seattle, Sonus Pharmaceuticals is
focused on the development of drugs that provide better therapeutic
alternatives for cancer patients, including improved efficacy,
safety and tolerability, and are more convenient to use. The
Company's lead oncology product candidate, TOCOSOL Paclitaxel, is
currently in a Phase 3 pivotal trial for the potential treatment of
metastatic breast cancer. In October 2005, Sonus entered into a
partnership agreement with Schering AG, Germany for the development
and commercialization of TOCOSOL Paclitaxel. In addition to the
continued progress with TOCOSOL Paclitaxel, the Company moved its
second product candidate, TOCOSOL Camptothecin, into Phase 1
clinical development in September 2006. TOCOSOL Camptothecin is a
new entry in the same drug class as the approved camptothecin
analogs, irinotecan and topotecan. Preclinical data suggest that
TOCOSOL Camptothecin may be more efficacious and better tolerated
than irinotecan. 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 therapeutic drugs and potential applications for
these products. As discussed in Sonus Pharmaceuticals' filings with
the Securities and Exchange Commission, including its Annual Report
on Form 10-K for 2005 and Quarterly Report on Form 10-Q for the
third quarter of 2006, 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 complete the
Phase 3 clinical trial for TOCOSOL Paclitaxel; risks that clinical
studies with TOCOSOL Paclitaxel will be delayed or will not be
successful; risks that the FDA may not approve the TOCOSOL
Paclitaxel New Drug Application; risks that the Phase 1 clinical
trial for TOCOSOL Camptothecin will not be successful; risks of
successful development of therapeutic drugs; 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.
Taxol(R) is a registered trademark of Bristol-Myers Squibb Company.
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