31.05.2007 19:40:00
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OXiGENE Reaches Agreement with FDA on Special Protocol Assessment for ZYBRESTAT(TM) (CA4P) Phase II/III Pivotal Trial in Anaplastic Thyroid Cancer
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN) a clinical-stage
biopharmaceutical company developing novel therapeutics to treat cancer
and eye diseases, announced today that the Company has reached agreement
with the U.S. Food and Drug Administration (FDA) on a Special Protocol
Assessment (SPA) for a Phase II/III pivotal trial of its potential
first-in-class vascular disrupting agent, ZYBRESTAT™
(combretastatin-A4 phosphate / CA4P) in anaplastic thyroid cancer (ATC).
The FDA’s agreement to the SPA means that, if
OXiGENE follows the agreed-upon protocol, the results of the trial
support the safety and effectiveness of ZYBRESTAT, and no substantive
scientific issues are identified after the trial begins, much of the
uncertainty associated with the design of a pivotal clinical trial
should be removed.
"Despite advances in the management of cancer,
there are no approved treatments for anaplastic thyroid cancer. By
working closely with the FDA to reach agreement on an SPA for this
trial, and given our promising Phase II data in ATC, we believe that we
have moved closer to our goal of providing an effective treatment for
patients suffering from this highly lethal form of cancer,”
commented Dr. Richard Chin, Chief Executive Officer and President of
OXiGENE.
The randomized and controlled Phase II/III clinical trial is expected to
enroll approximately 180 patients with ATC, two-thirds of whom will
receive intravenous ZYBRESTAT plus carboplatin and paclitaxel, and the
other third of whom will receive carboplatin and paclitaxel alone. The
primary endpoint will be a statistically significant difference in the
overall survival rate between the two treatment arms, as determined by a
log-rank analysis of Kaplan-Meier survival curves at times when
pre-determined numbers of study events (patient deaths) are reached. The
study design incorporates a planned interim analysis for efficacy and
safety which will be overseen by an Independent Data Monitoring
Committee. The Company currently plans to begin enrolling patients in
this trial in June 2007. Approximately 45 clinical trial sites worldwide
are expected to participate in the study.
The trial will be conducted under OXiGENE's Investigational New Drug
(IND) application on file with the FDA. ZYBRESTAT has received
fast-track designation by the FDA and has also been granted Orphan Drug
status in both the United States and Europe for thyroid cancer.
Additional information regarding the study design, enrollment criteria,
and participating centers will be available at http://www.clinicaltrials.gov
(keyword: anaplastic thyroid cancer).
Conference Call Scheduled for 9 a.m. EST on Friday, June 1, 2007
On Friday, June 1, 2007 at 9 a.m. EST a conference call will be webcast
to discuss the SPA. OXiGENE's President and Chief Executive Officer, Dr.
Richard Chin, will host the call. Chief Scientific Officer, Dr. David
Chaplin, Chief Business Officer, John Kollins and Chief Financial
Officer, James Murphy, will also participate.
To listen to a live or an archived version of the audio webcast, please
log on to the Company's website, www.oxigene.com.
Under the "Investor Center" tab, click on the link to "Presentations &
Conference Calls."
OXiGENE's conference call can also be heard live by dialing (800)
811-8845 (U.S. and Canada) or (913) 981-4905 (international) five
minutes prior to the call. A replay will be available starting at 12:00
p.m. EST on June 1, 2007 and ending at midnight EST on June 8, 2007. To
access the replay, please dial (888) 203-1112 (U.S. and Canada) or (719)
457-0820 (international) and refer to reservation number 5735734.
About Special Protocol Assessments
A Special Protocol Assessment (SPA) is an agreement with the U.S. Food
and Drug Administration that the Company’s
Phase II/III clinical trial design is acceptable and is robust enough to
form the basis of a regulatory approval based on the protocol design,
clinical endpoints, and statistical analyses, if pre-specified efficacy
results are achieved. The SPA process allows for FDA evaluation of a
clinical trial protocol intended to form the primary basis of an
efficacy claim in support of a New Drug Application (NDA). For more
information on Special Protocol Assessments, go to http://www.fda.gov/cber/gdlns/protocol.htm#ii.
About Anaplastic Thyroid Cancer
Anaplastic Thyroid Cancer (ATC) is one of the most lethal cancers known
in humans. There are no approved treatments for this disease. ATC is a
high-grade neoplasm, characterized by an aggressive clinical course with
brief survival, and refractoriness to currently available local and
systemic modalities of treatment. ATC comprises 1-2% of all primary
thyroid malignancies, and patients are often elderly (between 60-70
years of age). While ATC epidemiology has not been extensively studied
and documented, it is estimated that there are approximately 1,000 to
4,000 new cases per year in the U.S. and in Europe combined.
Newly-diagnosed ATC patients have a median life expectancy of
approximately 3 months, and only a very limited number of patients
survive for longer than one year.
Information for Patients and Caregivers
For further information about anaplastic thyroid cancer and the OXiGENE
Phase II/III ZYBRESTAT™ clinical trial, please
contact ThyCa: Thyroid Cancer Survivors' Association, Inc.:
ThyCA
www.ThyCa.org
(877) 588-7904
thyca@thyca.org
About ZYBRESTAT / Combretastatin A4P (CA4P)
The Company believes that ZYBRESTAT is poised to become the first
therapeutic product in a novel class of small-molecule drug candidates
called vascular disrupting agents (VDAs). Through interaction with
vascular endothelial cell cytoskeletal proteins, ZYBRESTAT selectively
targets and collapses tumor vasculature, thereby depriving the tumor of
oxygen and causing death of tumor cells. ZYBRESTAT has demonstrated
potent and selective activity against tumor vasculature as well as
clinical activity against ATC and other solid tumors in clinical studies
to date. Our strategy for optimizing the antitumor activity of ZYBRESTAT
is to combine it with other types of therapeutic modalities, including
cytotoxic drugs, anti-angiogenesis drugs, and radiation therapy. Our
rationale for combining ZYBRESTAT with other therapeutic modalities
stems from the hypothesis that agents with different and potentially
complementary mechanisms of action and with a non-overlapping toxicity
profile may achieve synergistic antitumor activity when administered
concurrently. In animal studies, ZYBRESTAT has been shown to enhance the
anti-tumor effects of several chemotherapeutic agents, several
anti-angiogenic drugs, and radiation.
About OXiGENE, Inc.
OXiGENE is a clinical-stage biopharmaceutical company developing novel
small-molecule therapeutics to treat cancer and eye diseases. The
Company's major focus is the clinical advancement of drug candidates
that selectively disrupt abnormal blood vessels associated with solid
tumor progression and visual impairment. OXiGENE is dedicated to
leveraging its intellectual property position and therapeutic
development expertise to bring life saving and enhancing medicines to
patients.
Safe Harbor Statement
This news release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Any or
all of the forward-looking statements in this press release, including
those relating to the successful completion of the planned Phase II/III
trial, approval by the FDA, enrollment of the first patient by June 2007
and ZYBRESTAT leading a novel class of small molecule drug candidates
may turn out to be wrong. Forward-looking statements can be affected by
inaccurate assumptions OXiGENE might make or by known or unknown risks
and uncertainties. Additional information concerning factors that could
cause actual results to materially differ from those in the
forward-looking statements is contained in OXiGENE's reports to the
Securities and Exchange Commission, including OXiGENE's Form 10-Q, 8-K
and 10-K reports. However, OXiGENE undertakes no obligation to publicly
update forward-looking statements, whether because of new information,
future events or otherwise. Please refer to our Annual Report on Form
10-K for the fiscal year ended December 31, 2006.
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