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医学捌号楼·医疗资讯·OXiGENE公司公布其治疗近视性黄斑病变(MMD-213)CA4P第二阶段临床试验成果
OXiGENE公司公布其治疗近视性黄斑病变(MMD-213)CA4P第二阶段临床试验成果
www.med8th.com  |  2007年3月5日

美国商业资讯2007年2月15日马萨诸塞州沃尔瑟姆消息——

OXiGENE 公司(纳斯达克股票代码:OXGN,斯德哥尔摩证券交易所:OXGN)是一家开发创新疗法治疗癌症及眼部疾病的临床生物技术公司,公司今天公布了其治疗近视性黄斑病变(MMD)CA4P(Combretastatin A4 Phosphate)第二阶段临床实验成果。这项研究的主要疗效指标就是维持视力(三个月内视力退化不超过视力表上三行的程度),所有患者达到这个疗效。该药物的安全性令人满意,达到了先前的预期,没有接到与该药物有关的严重不良反应报告。OXiGENE公司总裁兼首席执行官、医学博士Richard Chin评价说:“这些成果令人振奋,我们认为,它们为改进我们的黄斑病变项目提供了一个强有力的科学基础。我们相信,CA4P可能会成为治疗和预防老年性黄斑病变的安全、有效药物。”此次临床实验的所有结果将提交给五月在佛罗里达州Fort Lauderdale举行的视觉与眼科研究协会年会。

OXiGENE公司称,公司上周与美国食品及药物管理局结束了有关CA4P在治疗老年性黄斑病变过程中的两种局部眼药(滴眼液和眼微锭药(ocular mini-tabs))所举行的新药临床试验申请前(pre-IND)会议,并有意进行进一步的局部眼药开发。

最新的肿瘤项目

OXiGENE 公司还宣布,它与美国食品及药物管理局继续就其提出的未分化甲状腺癌(ATC)项目进行了积极的讨论,仍期望将于2007年上半年能够接收其第三阶段未分化甲状腺癌临床试验的首位患者。公司还表示,其他针对CA4P和OXi4503的肿瘤项目仍按计划继续进行,结果仍呈现出积极的安全性和疗效。

关于这项研究(MMD-213):

MMD -213是第二阶段、双任务(医师和接受试验的患者)、剂量大小的多中心研究,旨在评估静脉注射CA4P治疗病理性近视眼底中心近区脉络膜新生血管症状的安全性及有效性。试验对象分别接受了27、36或45 mg/m2的剂量进行治疗,总共有23名患者参与这项试验,每个试验项目7至8名患者。所有试验患者均接受积极的治疗,不过,试验患者和调查人员都不清楚所用剂量。每周接受两个剂量CA4P治疗的患者与再增加三个剂量的治疗患者分开,他们将进行为期3个月的有效性及安全性试验。主要效果变量是最佳的修正早期治疗糖尿病视网膜病变研究(ETDRS)视觉功能(视力)。次要变量包括荧光血管造影术和光学相干层析技术(OCT)。所有效果变量都由不知情的分级机构评定。安全性则通过重要的迹象、实验室测试、裂隙灯生物显微镜检查、扩大的眼底检查、眼底照相、系列ECG以及引发和观察到的不良反应来加以评估。 OXiGENE公司在整个试验过程中进行非正式的数据审查,以确保患者安全。

关于OXiGENE公司

OXiGENE公司是一家生物技术公司,开发治疗肿瘤和眼部疾病的新型小分子疗法。公司主要致力于备选药物的临床改进,这些药物可选择性地干扰与实体瘤增长和导致视觉缺陷相关的异常血管。OXiGENE公司致力于利用其拥有的知识产权及开发疗法的专门技术来挽救患者的生命,提高病人的用药效果。

免责声明

本新闻稿包含1995年《私人证券诉讼改革法案》界定的“前瞻性声明”,其中包括那些与公司正在开发的临床应用候选药物、CA4P和OXi4503的未来临床开发相关的声明。本新闻稿中的一些或所有前瞻性声明可能是错误的。前瞻性声明会受到OXiGENE公司可能进行的错误设想或受到已知或未知风险和不确定性因素的影响。有关可能导致实际结果与这些前瞻性声明所述的结果产生重大差异的因素的其他信息包含在OXiGENE公司提交给美国证券交易委员会的报告中,其中包括OXiGENE公司的10-Q表格、8-K和10-K报告。不过,无论是由于出现新信息、未来事件,还是由于出现其他情况,OXiGENE公司均不承担公开更新这些前瞻性声明的义务。请参考我们有关截至2005年12月31日结束的财年的10-K表格年度报告,了解对这些风险的描述。

联系方式:OXiGENE公司

投资者关系部

781-547-5900

(BW)(MA-OXIGENE)(OXGN)(OXGN.ST) 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.

CONTACT: OXiGENE, Inc.

Investor Relations

781-547-5900

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