OXiGENE Receives Meeting Minutes from FDA Type C Meeting on ZYBRESTAT(TM) Anaplastic Thyroid Program
March 21 2011 - 8:00AM
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical
company developing novel therapeutics to treat cancer and eye
diseases, announced today that it has received minutes from a Type
C meeting held on March 16, 2011, between OXiGENE and the US Food
and Drug Administration (FDA) to discuss next steps in the
development of ZYBRESTAT as a potential treatment for anaplastic
thyroid cancer (ATC).
As the company anticipated, the FDA indicated at the meeting
that the data from the FACT trial are suggestive of possible
clinical activity that may warrant continued development, and that
to seek regulatory approval, OXiGENE should plan to conduct an
additional clinical trial with a survival endpoint. The FDA also
confirmed that, as the company had expected, the Special Protocol
Agreement (SPA) that had been agreed upon at the start of the study
is no longer in effect.
"We appreciate the candid discussions and constructive feedback
we received from the FDA representatives," said Peter Langecker,
Chief Executive Officer of OXiGENE. "We believe that the
totality of the data, which showed that of 84 ATC patients treated
with ZYBRESTAT, 20 (approximately 24%) survived one year or longer
as compared to a historical rate of less than 10%, provides a
compelling basis for further study."
Dr. Langecker added: "We continue to be encouraged by the
outcomes in all of our clinical studies to date, including the ATC
study, and are reviewing our options to further develop our VDA
therapies and the additional funding that would be
needed through strategic partnerships and equity
financing."
The company has submitted an abstract and expects to present the
final data from the FACT study, an 80-patient, randomized,
controlled trial of ZYBRESTAT in combination with carboplatin and
paclitaxel in patients with ATC at ASCO in June 2011.
About ZYBRESTAT (fosbretabulin)
ZYBRESTAT is being evaluated in a Phase 2 study of patients with
non-small cell lung cancer and other clinical trials. OXiGENE
believes that ZYBRESTAT is poised to become an important product in
a novel class of small-molecule drug candidates called vascular
disrupting agents. 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. In clinical trials in solid
tumors, ZYBRESTAT has demonstrated potent and selective activity
against tumor vasculature, as well as clinical activity against
anaplastic thyroid cancer, ovarian cancer and various other solid
tumors.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing
novel therapeutics to treat cancer and eye diseases. The Company's
major focus is developing vascular disrupting agents that
selectively disrupt abnormal blood vessels associated with solid
tumor progression and visual impairment. OXiGENE is dedicated to
leveraging its intellectual property and therapeutic development
expertise to bring life-extending and life-enhancing medicines to
patients.
The OXiGENE, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=4969
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, which include additional drug development activities and
availability of additional financing or business partnerships 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, including, but not limited to,
the outcome of clinical studies, the level of interest among
potential business partners and the availability of additional
financing to continue development of OXiGENE's VDA therapies.
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 reports on
Form 10-K, 10-Q and 8-K. 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,
2010.
CONTACT: Investor and Media Contact:
Michelle Edwards, Investor Relations
medwards@oxigene.com
650-635-7006
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