基因治疗湿性黄斑变性人体实验2010.12启动
这个是英国牛津公司的FDA项目，I / II期有18个患者参加这个实验。
这个公司的另外两个基因实验项目：青少年黄斑变性从2011年第一季度开始人体实验，尤塞氏综合症从2011年下半年开始人体实验。
Clinical Trial for Wet AMD Gene Therapy to Begin in December 2010
Oxford Biomedica, a gene therapy company in the U.K., has received FDA authorization to launch a clinical trial of its RetinoStat® gene therapy for the treatment of wet age-related macular degeneration.
Eighteen people will be enrolled in the Phase I/II clinical trial to be conducted at The Wilmer Eye Institute at Johns Hopkins under the leadership of Peter Campochiaro, M.D. The trial is slated to begin by the end of December 2010.
“Oxford’s RetinoStat may be a more elegant approach for treating wet AMD than current alternatives, because a single injection has the potential to be effective in halting the growth of vision-robbing blood vessels under the retina for several years,” says Steve Bramer, Ph.D., chief drug development officer with the Foundation Fighting Blindness. “Furthermore, the success of the RetinoStat human study is helping drive the development of Oxford’s gene therapies for Stargardt disease and Usher syndrome type 1B.”
The Foundation Fighting Blindness’ clinical trial support organization has been partnering with Oxford Biomedica in its development of StarGen™ gene therapy for the treatment of Stargardt disease and UshStat® gene therapy for Usher syndrome 1B. The Foundation also supported Oxford in earlier preclinical studies of RetinoStat.
Oxford Biomedica is planning to launch its StarGen clinical trial during the first quarter of 2011. Their UshStat clinical trial is scheduled to begin in the second half of 2011. Both clinical trials will begin in Europe. All three of the company’s gene therapies employ lentivirus technology to deliver the corrective gene to the retina.
Dr. Campochiaro is the director of the Foundation’s Center Grant at The Wilmer Eye Institute. His research on a variety of retinal degenerative diseases has been funded by the Foundation for many years. |
