Blind World Magazine

Macular Degeneration.
Phase II Clinical Trial of NT-501 for the Treatment of Dry Age Related Macular Degeneration.




January 5, 2006.
Press Release. Neurotech, a biotechnology company specializing in the development of sight-saving innovative therapeutics for chronic retinal diseases, announced today the initiation of a Phase II clinical trial of NT-501, the Company's lead Encapsulated Cell Technology (ECT) product for the treatment of visual loss associated with the dry form of age related macular degeneration (dry AMD). NT-501 is an intraocular, polymer implant containing human retinal epithelial cells genetically modified to secrete Ciliary Neurotrophic Factor (CNTF). The implant is designed to continuously release CNTF directly in the eye to the diseased retinal tissue for sustained periods of time. The Phase II trial is a randomized, double-masked, sham-controlled dose ranging study that will evaluate the efficacy and safety of the CNTF implant and will be conducted at the National Eye Institute (NEI) in Bethesda, Maryland. "Dry AMD is a form of retinal disease that needs serious attention and we are very pleased to begin the Phase II trial for the indication," stated Ted Danse, CEO of Neurotech. "We believe the improvement in visual acuity observed in our Phase I trial will translate into a similar benefit for patients with advanced stage dry AMD." An open-label Phase I clinical trial of NT-501 was conducted in patients with retinitis pigmentosa (RP) by Paul A. Sieving, M.D., Ph.D., at the National Eye Institute. Dr. Sieving presented the results last November at the American Academy of Ophthalmology, and the results confirmed that CNTF can be safely delivered into the vitreous of patients with RP. The ECT implants were well tolerated by the RP patients, and some patients experienced improvement in their visual acuity score. According to Dr. Sieving, "The results from the Phase I trial have encouraged us to study NT-501 in patients with atrophic macular degeneration affecting their central vision, a type of degeneration that is similar to that seen in the late stage RP patients enrolled in the Phase I study." Two Phase II studies of NT-501 in patients with RP are also being planned for initiation in 2006 in conjunction with the NEI. Source URL: http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/01-05-2006/0004242937&EDATE=.




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