生物谷报道:MIGENIX Inc. (温哥华,Vancouver)是感染性疾病临床药物开发厂商,报导公司的Omigard(TM) (CPI-226)产品在北美及欧洲地区的合作伙伴公司Cadence Pharmaceuticals, Inc.己宣布将向美国FDA提出扩大Omigard(TM)药物的临床第三期测试规模,增加测试人数。
MIGENIX.执行长兼总裁Jim DeMesa医生说明,在和Cadence讨论法规申请案时,公司己同意对方试图强化研究成果统计的作法,因如此可以强化临床测试药物效正面成果的统计意义。当然,完成这项测试的时间可能就必须延后,相较于正面成果得到更好的肯定,如此的计划改变就将会是值得。http://www.migenix.com
英文原文:
Life Sciences News Brief
Vol.7 no.10 May. 9,2007
MIGENIX Inc. (Vancouver), a clinical-stage developer of drugs for infectious diseases, reports that the Company's development and commercialization partner for the North American and European markets for Omigard(TM) (CPI-226), Cadence Pharmaceuticals, Inc. announced that it intends to discuss with the U.S. Food and Drug Administration (FDA) a proposal to increase the number of patients to be enrolled in the ongoing, Phase III clinical trial of Omigard. "In discussions with Cadence regarding their preparations for regulatory submissions, we agreed with their approach to enhance the statistical power of the study and allow a better opportunity to achieve a positive result in this pivotal Phase III study," stated Jim DeMesa, M.D., President and CEO of MIGENIX. "While the timelines for completing enrollment in the study are anticipated to change, it will be well worth it if the planned increase leads to a positive result." http://www.migenix.com
