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.

RELATED: Neurologic Disorders Resource Center

GM604 was also granted a fast track designation for ALS in 2013.

For more information call (323) 721-5500 or visit Genervon.com

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