FDA Grants ALS Bio-Drug Orphan Drug Designation
Genervon was granted an orphan drug designation by the FDA for its bio-drug GM604 (also known as GM6) for the treatment of amyotrophic lateral sclerosis (ALS).
GM6 is a novel endogenous, multi-target, master regulator signaling peptide. GM6 is highly expressed in Week 9 of human embryonic/fetal gestation, and plays a significant role in nervous system development, protection, and correction. GM6 is also being studied in the following double-blind, randomized, placebo-controlled trials: Phase 2a trial for ALS, Phase 2a trial for Parkinson's disease, and a Phase 2 trial for ischemic stroke.
GM604 was also granted a fast track designation for ALS in 2013.
For more information call (323) 721-5500 or visit Genervon.com.