OXiGENE Announces Positive Results from its Phase II CA4P Clinical Trial in Myopic Macular Degeneration (MMD-213)WALTHAM, Mass.--(BUSINESS WIRE)--Feb 15, 2007 - OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a clinical-stage biotechnology company developing novel therapeutics to treat cancer and eye diseases, announced today positive results from its Phase II Combretastatin A4 Phosphate (CA4P) clinical trial in myopic macular degeneration (MMD). The primary efficacy endpoint of the study was maintenance of visual acuity (defined as less than a three line loss in visual acuity at 3 months) and 100% of the patients met this endpoint. Safety results were favorable and in line with expectations, with no drug related serious adverse events being reported. "These results are encouraging and we believe they form a sound scientific basis for advancing our macular degeneration programs. We also believe that CA4P has the potential to be a safe and effective drug for both treatment and prophylaxis of age-related macular degeneration" commented Richard Chin, M.D., President and Chief Executive Officer of OXiGENE. The full results of this clinical trial will be presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology in Fort Lauderdale, FL in May.
OXiGENE announced that it has completed a pre-IND meeting with the FDA regarding two topical ophthalmic formulations (eye drops and ocular mini-tabs) for CA4P in the treatment of age-related macular degeneration last week and intends to proceed with further development of topical formulations.
Oncology Program Update
OXiGENE also announced that it has had continued positive discussions with the FDA regarding its proposed anaplastic thyroid cancer (ATC) program, and continues to anticipate that the first patient will be enrolled in the Phase III ATC clinical trial in the first half of 2007. The Company also indicated that its other oncology programs for CA4P and OXi4503 are continuing to advance as planned, and that the results continue to be promising with respect to both safety and efficacy.
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/m2. A total of 23 subjects, 7-8 per arm, were enrolled. All subjects received 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 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, including those relating to the future clinical development of the Company's clinical-stage product candidates under development, CA4P and OXi4503. 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 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, 2005 for a description of these risks.
Posted: February 2007