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June 8, 2009
Neurotech Pharmaceuticals issued positive results from two phase II trials of NT-501 for the treatment of retinitis pigmentosa (RP). Both trials were a multi-centered, randomized, double-masked, placebo controlled dose ranging design. The first study enrolled 65 subjects with later stage RP (diagnoses of RP and vision between 20/63 and 20/320). The second trial studied 67 subjects with earlier stage RP (diagnoses of RP and vision better than 20/63). The subjects received either high dose or low dose NT-501 in one eye and placebo in the other eye. Best corrected visual acuity (BCVA) and visual field sensitivity (VFS) were evaluated as primary endpoints for the later stage study and the earlier stage RP study, respectively. At 12 months no trend in visual benefit was observed in either study for these functions. However, in both studies, there was a statistically significant, dose-dependent increase in retinal thickness involving photoreceptor layers as measured by optical coherence tomography (p< 0.001 for the high dose group in each study). No treatment-related serious adverse events were reported and both NT-501 and the surgical procedure were well-tolerated.