FDA allows Revalesio IND to study RNS60 in ALS
The Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application submitted by Revalesio for Phase II clinical testing of RNS60 in patients with amyotrophic lateral sclerosis (ALS).
RNS60 is currently evaluated in a pilot study in ALS patients at Massachusetts General Hospital. The study was initiated by the study investigators and is funded by the ALS Therapy Fund. An investigator-sponsored, placebo-controlled, multicenter Phase II study that received grant funding from the ALS Association and ALS Finding a Cure® is expected to start enrolling patients as early as March of 2017.