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Results From Neurotech's NT-501 Phase 2 Retinitis Pigmentosa Studies Demonstrate Consistent Biological Effect on Photoreceptors
Date:5/28/2009

he two Phase 2 studies were multi-centered, randomized, double-masked, sham-controlled dose ranging studies designed to evaluate the safety and efficacy of NT-501 in patients with RP. The first trial studied 65 patients with later stage RP (defined as patients diagnosed with RP and vision between 20/63 and 20/320). The second trial studied 67 patients with earlier stage RP (defined as patients diagnosed with RP and vision better than 20/63). In both studies each patient received either a high or low dose NT-501 implant in one eye and a sham treatment in the fellow control eye. Best corrected visual acuity (BCVA) and visual field sensitivity (VFS) were evaluated as primary endpoints for patients in the later stage and earlier stage RP studies, respectively. At 12 months no trend in visual benefit was observed in either study for these functions, possibly due to the slow progression of the disease. RP patients in general have a gradual progression of vision loss, often over many years or decades. These patients will continue to be monitored for an additional 6 to 18 months per protocol. There were no NT-501 associated serious adverse events reported and both NT-501 and the surgical procedure were well-tolerated.

"CNTF has the potential to help people with retinitis pigmentosa and other photoreceptor degenerations," said Dr. Paul Sieving, Director of the National Eye Institute and Principal Investigator of Neurotech's Phase 1 study of NT-501 in RP. "These studies are important as they present an opportunity to move the field forward."

"We are hopeful that the biological changes observed in RP patients treated with NT-501 will lead to a benefit in visual function," stated Dr. David Birch, Director of the Retina Foundation of the Southwest and lead investigator for the RP studies. "However, the progression of this disease is slow and we have not seen a visual benefit in the treated eye relative to the control eye over this relatively
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SOURCE Neurotech Pharmaceuticals, Inc.
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