March 14, 2006.
Neurotech, a biotechnology company specializing in the development of innovative sight-saving therapeutics for chronic retinal diseases, announced today the publication of findings from its Phase I study of NT-501 for the treatment of Retinitis Pigmentosa (RP) in the March 7th issue of Proceedings of the National Academy of Sciences (PNAS).
NT-501, the Company's lead Encapsulated Cell Technology (ECT) product is an intraocular, polymer implant containing human retinal pigment epithelial cells genetically modified to secrete Ciliary Neurotrophic Factor (CNTF). The implant is designed to continuously release CNTF directly in the eye to retinal tissue for sustained periods of time.
The open-label Phase I study, conducted by lead investigator Paul A. Sieving, M.D., Ph.D., of the National Eye Institute (NEI), was designed to assess the safety and tolerability of NT-501 in ten patients with RP. In the study, two doses of CNTF were evaluated. NT-501 was implanted in one eye per patient and then removed after six months. The results of the study showed that NT-501 can be safely implanted into the eye and was found to be well tolerated by patients.
In addition, while the study was not designed to assess clinical efficacy, three of seven patients with evaluable visual acuity experienced an improvement in visual acuity.
"This Phase I study is a promising first step in evaluating the therapeutic potential of CNTF for diseases causing retinal and macular degeneration," stated Dr. Sieving, the lead author of the paper. "In addition to safety and tolerability, I was encouraged by the apparent improvement in visual acuity scores of some patients."
"The results of the study demonstrate that CNTF can be safely delivered into the eye via ECT," stated Weng Tao, M.D., Ph.D, Chief Scientific Officer and a co-author of the paper. "This shows that ECT is a viable platform for the delivery of a variety of potential therapeutic factors to the eye for various retinal diseases."
"It is rewarding to see that our Phase I results are published in a prestigious journal such as PNAS," stated Ted Danse, President and Chief Executive Officer of Neurotech. "The Company is committed to advancing NT-501 for retinal degenerative diseases with the continued support of the NEI and the Foundation Fighting Blindness. We will initiate two multi-center Phase II clinical trials for retinitis pigmentosa in 2006."
About Retinitis Pigmentosa (RP) RP is a group of inherited retinal diseases that affect about 100,000 Americans and 1.5 million people worldwide. It causes the progressive deterioration of retinal cells in the back of the eye responsible for visual function. As these cells slowly degenerate, people with RP develop night blindness and a gradual loss of peripheral vision. By about age 40, most have tunnel vision, although many may retain good central vision. However, with time they typically lose their remaining eyesight.
About Encapsulated Cell Technology (ECT) ECT is a unique technology that enables the controlled, continuous, long- term delivery of therapeutic proteins directly to the back of the eye. ECT relies on the use of an immunoisolatory hollow fiber membrane technology to allow the implantation of genetically engineered cells that continuously produce the therapeutic protein at the site of implantation.
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