OXiGENE Announces Publication of Phase 2 Study Results With Fosbretabulin (ZYBRESTAT(tm)) Monotherapy in Anaplastic Thyroid Cancer (ATC)


WALTHAM, Mass., March 17, 2009 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN)
(XSSE:OXGN), a clinical-stage, biopharmaceutical company developing novel
therapeutics to treat cancer and eye diseases, announced the publication of
results from a 26-patient, Phase 2 study of fosbretabulin (ZYBRESTAT) in
anaplastic thyroid cancer (ATC) in the current issue of the journal THYROID.
The authors of the study, titled "A Phase II Trial of Fosbretabulin in Advanced
Anaplastic Thyroid Carcinoma and Correlation of Baseline Serum-Soluble
Intracellular Adhesion Molecule-1 with Outcome" (Mooney et al, Vol. 19, Num.3,
2009), concluded that fosbretabulin, administered as a single agent to ATC
patients who had progressed or relapsed following initial therapy, appeared to
be well-tolerated with encouraging survival results that provide a strong
rationale for the ongoing Phase 2/3 pivotal registration study with
fosbretabulin in ATC (FACT trial). 

"We believe these Phase 2 data with fosbretabulin monotherapy in ATC, in
conjunction with other Phase 1/2 results with fosbretabulin in ATC in which
both clinical activity and significant tumor blood-flow reductions have been
observed, as well as supportive preclinical data, provide strong support for
the ongoing FACT pivotal trial in ATC," commented Dr. Patricia Walicke,
OXiGENE's Chief Medical Officer. 

Results of the Phase 2 Monotherapy Study

The Phase 2 monotherapy trial was conducted at three centers in the U.S. and
enrolled 26 patients with biopsy-proven advanced or metastatic ATC. The
majority of patients had prior therapy (92%) and metastatic disease (73%;
because of the highly aggressive nature of ATC, most patients are considered
metastatic upon diagnosis). Fosbretabulin was administered on days 1, 8 and 15
of each 28-day cycle in a 10-minute intravenous infusion of 45 mg/m2. A total
of 77 cycles of therapy were administered with a median of 2 cycles per patient
(range 1-9). Treatment was continued until disease progression. 

Seven patients (27%) experienced stable disease for at least six weeks, with a
median duration of 12.3 months (range: 4.4 - 37.9 months). The median survival
of patients in the study was 4.7 months, with 34% of patients alive at 6 months
and 23% of patients alive at 12 months. Event-free survival at 3 months was
23.1% and at 6 months was 7.7%. At the end of the study, 23 of the 26 patients
had expired. Three patients were alive at the time of last follow-up at 12.1+,
24.4+ and 37.9 months. 

The Phase 2 data showed that fosbretabulin appeared to be well-tolerated. The
most common side effects were gastrointestinal (mild nausea, vomiting) and
headache, all of which resolved within 24 hours of drug administration.
Myelosuppression was negligible. Of the 26 patients, grade 3 toxicity was
observed in 9 patients (35%) and one patient experienced a grade 4 toxicity
(tumor pain). QTc prolongation delayed treatment in 4 patients, one of whom
stopped treatment. There was no ECG or clinical evidence of other
cardiovascular toxicity. 

A secondary aim of the Phase 2 trial was evaluation of whether baseline levels
of soluble intracellular adhesion molecule-1 (sICAM), an endothelial
cell-specific marker, could be used prognostically as a biomarker and
predictively to identify a patient population that would be responsive to
treatment with a vascular disrupting agent. Results of the trial showed that
low baseline sICAM levels were predictive of event-free survival. These results
suggest that sICAM may have value as a therapeutic biomarker, and warrants
further study in additional clinical trials of vascular disrupting agents and
other antivascular therapies that are designed to damage tumor vasculature. 

Fosbretabulin Phase 2/3 FACT Trial Progressing

The pivotal registration Phase 2/3 FACT (fosbretabulin in anaplastic cancer of
the thyroid) trial is a 180-patient, multicenter, open-label, randomized study
in patients with anaplastic thyroid cancer to evaluate the safety and efficacy
of fosbretabulin (dosed at 60 mg/m2) in combination with paclitaxel and
carboplatin in comparison with paclitaxel and carboplatin alone. The FACT trial
is actively recruiting and enrolling patients with regionally-advanced or
metastatic anaplastic thyroid cancer at approximately 40 sites throughout the
United States, Eastern and Western Europe, Asia, and the Middle East. (For
further information on the FACT trial, please visit
www.oxigene.com/clinical_trial_fact.php) The FACT trial design incorporates a
planned interim analysis upon a reaching a specified number of events (deaths),
and based on current enrollment rates and projections, OXiGENE anticipates that
the interim analysis will be conducted in the first half of 2010. 

OXiGENE is conducting the pivotal registration trial under a Special Protocol
Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
The FDA has also granted fast track designation for fosbretabulin in ATC and
both the FDA and European Commission have designated fosbretabulin for ATC as
an orphan drug. 

About ZYBRESTAT (fosbretabulin)

ZYBRESTAT is currently being evaluated in a pivotal registration clinical trial
in anaplastic thyroid cancer (ATC) under a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration (FDA). Additional Phase 2
studies are ongoing in non-small cell lung cancer (NSCLC) and
platinum-resistant ovarian cancer. (For further information on the FALCON study
in NSCLC, see www.falcontrial.com). OXiGENE 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. In clinical trials in solid tumors, ZYBRESTAT has
demonstrated potent and selective activity against tumor vasculature, as well
as clinical activity against ATC, ovarian cancer and various other solid
tumors. In clinical trials in patients with forms of macular degeneration,
intravenously-administered ZYBRESTAT has demonstrated activity, and the
Company's objective is to develop a convenient and patient-friendly topical
formulation of ZYBRESTAT for ophthalmological indications. OXiGENE is
developing ZYBRESTAT for ophthalmology under the strategic drug development
partnership it established with Symphony Capital in October 2008. 

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 (VDAs) 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 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 enrollment rate for patients in the ZYBRESTAT pivotal trial for
anaplastic thyroid cancer, an interim analysis of the same, reporting of final
results from the Phase 2 clinical trial of ZYBRESTAT in patients with
platinum-resistant ovarian cancer, timing and success of preclinical studies
and initiation of a clinical trial of topical-route ZYBRESTAT, timing of
reporting interim and final data from the Phase 2 clinical trial of ZYBRESTAT
in NSCLC, and timing or execution of a potential strategic collaboration on any
product or indication or any other transaction. 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, 2007. 

CONTACT:  OXiGENE, Inc.
          Investor Relations
          Michelle Edwards
          650-635-7006
          medwards@oxigene.com