GenSight announces results from Phase I/lla trial REVEAL in BioDrugs
Category: #health  By Pankaj Singh  Date: 2021-02-16
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GenSight announces results from Phase I/lla trial REVEAL in BioDrugs

GenSight Biologics, a biotechnology company, has recently announced the results from the Phase I/lla clinical trial, REVEAL, in the peer-reviewed journal, BioDrugs. This clinical trial has been conducted with an aim to examine the safety of the LUMEVOQ® gene therapy in participants with ND4 LHON (Leber Hereditary Optic Neuropathy) as well as to subsequently determine the dose in the Phase III trials, i.e. RESCUE and REVERSE.

REVEAL is an open-label, dose-escalation, single-center trial launched in 2014 to evaluate the tolerability and safety of lenadogene nolparvovec in 15 participants, who have been examined over 5 years after a single intravitreal injection to the worst affected eye. These participants were sequentially enrolled in four cohorts of three subjects each. Additionally, each cohort received an increasing number of doses of the gene therapy, following a safety evaluation by an independent DSMB (data safety monitoring board).

No serious adverse events had been considered over the 5-year follow-up period, with no occurrence of unexpected side-effects and no Grade 3 or 4 CTCE (Common Terminology Criteria for Adverse Events) being reported.

According to Dr. Catherine Vignal, MD, lead investigator, Department of Neuro-Ophthalmology & Emergencies in Rothschild Foundation Hospital and Centre Hospitalier National d’Ophtalmologie des Quinze Vingts, the REVEAL study has demonstrated significant tolerance of the lenadogene nolparvovec treatment for both long- and short-term. The trial has successfully obtained encouraging results and has paved the way towards the efficacy investigations of RESCUE and REVERSE.

GenSight Biologics is also planning to provide the topline results from the Phase III REFLECT trial in the Q2 of 2021. The clinical trial will examine the safety and efficacy of the bilateral injections of LUMEVOQ® among subjects with LHON due to a mutated ND4 gene. REFLECT has been developed under a Special Protocol Assessment deal reached with the U.S. FDA (Food and Drug Administration).

The trial data and analyses of the LUMEVOQ® gene therapy under REVEAL were the evidence package’s integral components, which was submitted to the European Medicines Agency in September 2020 by GenSight Biologics.

Source credit:

https://www.businesswire.com/news/home/20210214005044/en/GenSight-Biologics-Announces-Publication-of-Results-from-LUMEVOQ%C2%AE-Phase-IIIa-Clinical-Trial-REVEAL-in-BioDrugs

 



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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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