The following are the poster session details: -0-
Poster No.: 1457/B534 Abstract Phase II Clinical Trial of Intravenous Combretastatin A4 Title: Phosphate in Patients With Subfoveal Choroidal Neovascular Membranes (CNV) in Pathologic Myopia Presentation Monday, May 07, 2007, 8:30 AM -10:15 AM Time:
The poster provided additional details from the ZYBRESTAT(TM) CA4P Phase II clinical trial (MMD-213) in Myopic Macular Degeneration, top-line results from which the Company previously announced on February 15, 2007. Based on the positive results from this study, in which 100% of patients met the primary endpoint of maintenance of visual acuity, the Company has held a pre-IND meeting with the FDA regarding topical ophthalmic formulations (eye drops and ocular mini-tabs), is proceeding with development of a topical formulation of ZYBRESTAT(TM), and anticipates filing and IND and initiating clinical studies with the formulation in early 2008.
About the Study (MMD-213):
MMD-213 was a Phase II, double-masked (physician and subject), dose-ranging, multi-center study designed to evaluate the safety and efficacy of intravenous CA4P for treating subfoveal choroidal neovascularization in subjects with pathologic myopia. Subjects were assigned to receive CA4P at doses of 27, 36 or 45 mg/m(2). A total of 23 subjects, 7-8 per arm, were enrolled. All subjects receive d active treatment; however, subjects and investigators were masked to dose. Subjects received two doses of CA4P one week apart with up to 3 additional doses and they were followed for 3 months for efficacy and safety. The primary efficacy variable was the best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual function (visual acuity). Secondary variables included fluorescein angiography and optical coherence tomography (OCT). All efficacy variables were evaluated by a masked grader. Safety was assessed via vital signs, laboratory tests, slit-lamp biomicroscopy, dilated fundus examination, fundus photography, serial ECGs and elicited and observed adverse events. Informal data reviews were conducted by OXiGENE throughout the trial to ensure patient safety.
About OXiGENE, Inc.
OXiGENE is a clinical-stage biotechnology company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company's major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving 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 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-Q, 8-K and 10-K reports. However, OXiGENE undertakes no oblig ation 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, 2005 for a description of these risks.
NOTE TO EDITORS: In the expression, mg/m(2), which appears in the paragraph, About the Study (MMD-213):, the figure '2' is in superscript. This feature may not appear properly in some systems.