Phase III clinical trials with NT 501 ECT showed statistical significance for the primary endpoint in Macular telangiectasia type 2
Neurotech Pharmaceuticals announced positive topline results in two replicative Phase III clinical trials with NT 501 ECT, their investigational encapsulated cell therapy (ECT) for the treatment of Macular telangiectasia type 2 (MacTel), an orphan, slowly progressive degenerative disease of the macula that results in gradual deterioration of central vision
The multicenter, randomized, sham-controlled studies were designed to evaluate the safety and efficacy of the investigational NT 501 implant. The studies demonstrated statistical significance for the pre-specified primary endpoint, rate of change in ellipsoid zone (EZ) area loss from baseline through 24 months. The rate of change in area loss translates to and demonstrates a change in the rate of photoreceptor loss.
Clinically relevant and statistically significant primary results with the NT 501 implant demonstrated change in the rate of progression of disease in Macular telangiectasia type 2 (MacTel) patients in two pivotal Phase III Trials; 56.4% rate of reduction in Protocol A (p<0.0001) and 29.2% rate of reduction in protocol b (p="0.021)." positive results from the nt 501 implant are the first phase iii clinical validations demonstrating preservation of photoreceptors with a novel ophthalmic neuroprotectant therapy (ciliary neurotropic factor (cntf)). finally nt 501 implant was demonstrated to be safe, durable, and well tolerated in protocol a and protocol b.
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