Date: 2014-04-03
Type of information: Recruitment of the first patient
phase: 1-2
Announcement: enrollment of the first patient
Company: Dompé (Italy)
Product: recombinant human Nerve Growth Factor (rhNGF)
Action
mechanism: protein
Disease: retinitis pigmentosa
Therapeutic area: Ophtalmological diseases - Rare diseases
Country: Italy
Trial
details: Lumos is a Phase Ib/II, multicentre, randomised, double-masked, placebo-controlled study that aims to assess the safety and potential efficacy of rhNGF eye drops in two doses (60 and 180 µg/ml), compared to a placebo. The research will involve 50 patients, who will be enrolled at five centres in Florence, Milan, Rome (two centres) and Naples. Patients with typical retinitis pigmentosa will be divided into three groups. The first will be given eye drops at the lower dose, the second an increased dose and the third placebo eye drops. The monitoring schedule for each patient is 24 weeks.
Latest
news: * On April 3, 2014, Dompé has announced that the first patient is enrolled in Lumos study. This study aims to evaluate safety and potential efficacy of rhNGF in the treatment of retinitis pigmentosa. This recombinant human Nerve Growth Factor (rhNGF), developed and manufactured by the Dompé Group and based on the research of Nobel Prize winner Rita Levi Montalcini, recently received orphan drug designation from the European Medicines Agency (EMA) and the United States FDA regulatory agencies for the treatment of retinitis pigmentosa. The molecule - currently in clinical development for the treatment of neurotrophic keratitis (a rare disease of the cornea) in the Reparo study, involving 158 patients in 39 centres in nine European countries - is now being evaluated for its safety profile and to obtain preliminary efficacy data, as part of the Lumos study, involving five centres of excellence in Italy. The first patient was enrolled at the Careggi University Hospital in Florence. The LUMOS study was started in December 2013 to evaluate the efficacy and safety of rhNGF in the treatment of this disease.
