OXiGENE Reports Positive Interim Results from Phase Ib Zybrestat - Bevacizumab Combination Study in Advanced Solid Tumors
WALTHAM, Mass. -- Oct 5, 2007 - OXiGENE, a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that interim results from an ongoing Phase Ib study of its lead product candidate, ZYBRESTAT(TM) (combretastatin-A4 phosphate / CA4P), administered in combination with bevacizumab (AVASTIN(R)) to patients with advanced solid tumors, were presented today at the European School of Haematology's International Conference on Vascular Targeted Therapies in Oncology in Mandelieu, France.
Based on results from the first two of three dose cohorts in the study, in which a total of six patients were evaluable, the ZYBRESTAT-bevacizumab combination appeared safe and well-tolerated, resulted in significantly enhanced tumor blood-flow reductions as measured by DCE-MRI imaging, and demonstrated early evidence of clinical activity in the absence of concurrent cytotoxic chemotherapy. A copy of the poster presentation is available at www.oxigene.com under Press Room / Publications.Â
"These encouraging initial data underscore the potential for delivering enhanced benefits to solid tumor patients by combining these different-yet-complementary therapies to deprive tumors of blood supply," commented Richard Chin, M.D., chief executive officer and president of OXiGENE. "Based on the results from this study, we plan to initiate by the first quarter of 2008 a controlled Phase II study of ZYBRESTAT plus bevacizumab and standard chemotherapy in patients with non-small-cell lung cancer."
The principal investigator of this trial, Dr. Paul Nathan of the Mount Vernon Cancer Centre, United Kingdom, commented, "This is the first-ever clinical trial combining a vascular disrupting agent and an anti-angiogenic drug. Importantly, the interim results provide evidence of enhanced activity with this chemotherapy-free combination regimen, as was initially predicted in preclinical studies. The interim results to date indicate that the CA4P-bevacizumab combination appears safe and well-tolerated, and functional imaging demonstrates additive effects on tumor vasculature. In addition, early evidence of clinical activity has been seen, based on the number and duration of stable-disease responses achieved in these patients with advanced disease."
The ongoing Phase Ib study is an open-label, dose-escalation study designed to evaluate safety and tolerability, pharmacodynamics, pharmacokinetics, and biomarkers associated with three dosages of ZYBRESTAT (45 mg/m2, 54 mg/m2 and 63 mg/m2) in combination with bevacizumab (10mg/kg administered every 14 days). OXiGENE anticipates completing enrollment in the study in the current quarter and reporting further data from all dose cohorts at an appropriate scientific forum in 2008.
About ZYBRESTAT / Combretastatin A4P (CA4P)
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. ZYBRESTAT has demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against ATC and other solid tumors in clinical studies.
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 -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 future clinical development of ZYBRESTAT, future results of the ongoing Phase Ib clinical trial, approval by the FDA, timing of patient enrollment, the effective combination of ZYBRESTAT with other drugs, 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-K, 10-Q and 8-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.