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.
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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.