Healthcare Industry News: optical coherence tomography
News Release - September 12, 2006
OXiGENE to Focus Ophthalmology Strategy Toward Non-Invasive Administration of CA4P for Age-Related Macular Degeneration (AMD)Closes Enrollment of Phase II CA4P Clinical Trial in Myopic Macular Degeneration (MMD-213)
WALTHAM, Mass.--(HSMN NewsFeed)--Sept. 12, 2006--OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it is planning to focus its ophthalmology strategy on oral or other non-intravitreal forms of administrations of Combretastatin A4 Phosphate (CA4P) for age-related macular degeneration (AMD). "Having developed one of the leading current therapies for AMD during my tenure at Genentech, I am well aware of the advantages of better administration options in this disease state" commented Richard Chin, M.D., President and Chief Executive Officer. "We believe pursuing an indication in AMD for CA4P is the right strategy for patients provided we see maintenance of vision in a similar range as current antiangiogenic agents and CA4P continues to demonstrate an acceptable safety profile" Dr. Chin continued. "Our goal in ophthalmology, as in oncology, is to deploy our resources thoughtfully toward meeting the greatest unmet medical need."
The Company also announced the closure of enrollment of its Phase II CA4P clinical trial in myopic macular degeneration (MMD-213), with 22 of the previously planned 36 patients enrolled to date. The last of the enrolled patients are expected to complete the MMD trial by the end of the year. This trial was designed to evaluate the safety and efficacy of three dose groups (27, 36, and 45 mg/m2) of CA4P for the treatment of subfoveal choroidal neovascularization (CNV) in subjects with pathologic myopia. "We are satisfied with the results of the trial to date and believe that we will have enough data from the trial to now focus our ophthalmology efforts on more effective methods of administration for AMD," added Dr. Chin. OXiGENE is committed to ophthalmology and is evaluating opportunities that it believes may provide the greatest benefit to patients from CA4P, which includes optimizing the dosage formulation for ease of administration.
Results from this trial are expected to be reported in the first quarter of 2007.
About the Trial:
MMD-213 is a Phase II, masked, parallel-group, dose-ranging, multi-center trial designed to evaluate the safety and efficacy of CA4P for treating subfoveal choroidal neovascularization in subjects with pathologic myopia. A total of 36 subjects, 12 per arm, were to be enrolled. Subjects are assigned to receive CA4P at doses of 27, 36 or 45 mg/m2. All subjects receive active treatment; however, patients and investigators are masked to dose. Patients are eligible to receive two doses of CA4P one week apart and are followed for 3 months for efficacy and safety. The primary efficacy variable in this trial is the best corrected ETDRS visual function (visual acuity). Secondary variables include fluorescein angiography and optical coherence tomography (OCT). All efficacy variables are evaluated by a masked grader. Safety is being assessed via vital signs, laboratory tests, slit-lamp biomicroscopy, dilated fungus examination, fundus photography, serial ECGs and elicited and observed adverse events. Informal data reviews are conducted by OXiGENE throughout the trial to ensure patient safety. Patients who have already been assigned to treatment will have the opportunity to continue in the trial as planned. To date, the safety profile observed in this trial has been consistent with other trials of CA4P.
About OXiGENE, Inc.
OXiGENE is an emerging pharmaceutical 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. These statements include, but are not limited to: the ability to develop noninvasive means of administration of CA4P for AMD, the ability to demonstrate CA4P's acceptable safety profile, the ability to maintain vision in a similar range as current antiangiogenic agents, the timing and results and presentation of data in the Phase II clinical trial in MMD-213, and the capability to broaden ophthalmology targets to include AMD and further develop CA4P for use in ophthalmologic indications. 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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