Pipex Pharmaceuticals has announced positive results from a double-blind, placebo-controlled clinical trial for the treatment of dry age-related macular degeneration with oral Zinthionein.
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Zinthionein capsules (25mg capsules twice daily) were compared to placebo capsules twice daily on a 1:1 randomization scheme in a prospective, randomized, double-blind, placebo-controlled trial involving a total of 80 dry age-related macular degeneration (AMD) patients for period of six months at a single site.
After six months, compared to placebo treated patients, Zinthionein treated patients demonstrated a highly statistically significant improvement in visual acuity (p < 0.0001), contrast sensitivity (p < 0.0001) as well as photorecovery time (p=0.0001), each of which represent carefully measured endpoints of global central retinal function that is compromised in AMD. The study met all global central retinal function measurements of the clinical trial. Zinthionein appeared to be well tolerated in the study, with only a 2% gastrointestinal irritation rate as compared to placebo. David Newsome, primary investigator of the clinical trial, and a scientific advisor to Pipex, said: "It is very rare for a Phase II dry AMD study to demonstrate significance on all of the measurements of global retina function with strong statistical significance. I look forward to continued collaboration with the Pipex team to further develop Zinthionein as a potential new therapy for dry AMD."
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