OXiGENE Announces Positive Results from its Phase II CA4P Clinical Trial in Myopic Macular Degeneration (MMD-213).WALTHAM, Mass. -- OXiGENE, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : 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 MMD Movement for Multiparty Democracy (Zambia) MMD Make My Day MMD Merchant Mariner Document MMD Myotonic Muscular Dystrophy MMD Myotonic Dystrophy MMD Mass Median Diameter MMD Metal Matrix Diaphragm ). 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 Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. " 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 an·a·plas·tic adj. 1. Relating to the surgical restoration of a lost or absent part. 2. Of, relating to, or characterized by cells that have become less differentiated. anaplastic 1. 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 cho·roi·dal adj. Of or relating to the choroid. choroidal pertaining to or emanating from the choroid. choroidal hypoplasia 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 ETDRS Early Treatment Diabetic Retinopathy Study ) visual function (visual acuity). Secondary variables included fluorescein angiography and optical coherence tomography Optical coherence tomography (OCT) is an interferometric, non-invasive optical tomographic imaging technique offering millimeter penetration (approximately 2-3 mm in tissue) with micrometer-scale axial and lateral resolution. (OCT OCT ornithine carbamoyltransferase; oxytocin challenge test. OCT ornithine carbamoyl transferase, a liver specific enzyme. OCT Oxytocin stress test, see there ). All efficacy variables were evaluated by a masked grader. Safety was assessed via vital signs, laboratory tests, slit-lamp biomicroscopy, dilated fundus examination Dilated fundus examination(DFE) is diagnostic procedure that employs the use of mydriatic eye drops to dilate or enlarge the pupil in order to obtain a better view of the internal surface of the eye (i.e. fundus) with an ophthalmoscope. , fundus fundus /fun·dus/ (fun´dus) pl. fun´di [L.] the bottom or base of anything; the bottom or base of an organ, or the part of a hollow organ farthest from its mouth. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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