WALTHAM, Mass., Oct. 27, 2008 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN) (Stockholm:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, reported positive interim results from an ongoing phase 2 study of ZYBRESTAT in patients with platinum-resistant ovarian cancer. Ten of 34 evaluable patients (29%) enrolled to date in the ongoing, single-arm, Simon two-stage design study evaluating the combination of ZYBRESTAT and chemotherapy (carboplatin and paclitaxel) had partial responses as measured by tumor imaging (RECIST) and/or ovarian cancer biomarker (CA-125) criteria. An additional unconfirmed partial response was observed in a patient lost to follow up, and stable disease responses were observed in an additional nine patients. The combination regimen of ZYBRESTAT and chemotherapy was observed to be well tolerated.
"The results of this study in patients resistant to platinum-based therapy are highly encouraging and support further evaluation of ZYBRESTAT in patients with ovarian cancer," commented Professor Gordon Rustin, of Cancer Research UK. Professor Rustin, who presented the data at the 12th Biennial Meeting of the International Gynecologic Cancer Society in Bangkok, Thailand, is the principal investigator of the study and an internationally recognized expert in the management of gynecological malignancies.
"The data presented are consistent with the overall results we have seen in approximately 350 patients to date indicating that ZYBRESTAT appears to be well-tolerated and has clinical activity against a variety of tumor types, including difficult-to-treat malignancies such as platinum-resistant ovarian cancer and anaplastic thyroid cancer," commented Patricia Walicke, M.D., Ph.D., Chief Medical Officer at OXiGENE. "Moreover, the results presented are consistent with preclinical data from ovarian cancer xenograft models suggesting ZYBRESTAT may restore platinum-sensitivity to platinum-resistant tumors by necrosing the tumor core, an area within a tumor thought to become most resistant to chemotherapeutic agents such as platinum therapeutics."
ZYBRESTAT Phase 2 Platinum-Resistant Ovarian Cancer Study
Data reported are based on a preliminary analysis of 34 evaluable patients enrolled to date in the phase 2 trial. Per the study design, total enrollment in the trial is anticipated to be 43 patients. Patients in the study had received between one and seven prior lines of chemotherapy and were confirmed to have platinum-resistant ovarian cancer. Platinum resistance is defined as disease relapse within six months of completing treatment with platinum-based therapy, and the patients enrolled in the study would therefore not be expected to respond to further treatment with platinum-based therapy.
Patients in the study were given a 10-minute infusion of ZYBRESTAT, followed by standard doses of carboplatin and paclitaxel within 18-22 hours. This combination was repeated every 3 weeks for up to 6 cycles. The combination regimen of ZYBRESTAT, carboplatin and paclitaxel appeared to be well-tolerated, with the most frequently reported side-effects being transient nausea, fatigue and tumor pain (predominately grade 1 and 2).
In December 2007, OXiGENE reported that the study met the primary efficacy endpoint of Stage 1 of the Simon two-stage study. In the first stage, 5 of the 18 patients responded to ZYBRESTAT (i.e., achieved a partial response per RECIST and/or ovarian cancer biomarker (CA-125) criteria). Twenty-five patients are expected to be enrolled in the second stage of the study. The company expects final data from this study in the first half of 2009.
About ZYBRESTAT
ZYBRESTAT (fosbretabulin) is currently being evaluated in a pivotal registration study as a potential treatment for anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). Phase II studies in platinum-resistant ovarian cancer and non-small cell lung cancer are also ongoing. 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 studies 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 studies in patients with forms of macular degeneration, intravenously-administered ZYBRESTAT has demonstrated clinical activity, and the Company is working to develop a convenient and patient-friendly topical formulation of ZYBRESTAT for ophthalmological indications.
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 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 -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, enrollment rate for patients in the ZYBRESTAT pivotal trial for anaplastic thyroid cancer, interim analysis of the same, timing of the IND filing and Phase I trial initiation for topical ZYBRESTAT, timing of a Phase II clinical trial of ZYBRESTAT and bevacizumab in NSCLC, timing or execution of a strategic collaboration on any product or indication, and cash utilization rates for 2008. 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.