FDA grants fast track designation to Genervon Biopharmaceuticals for ALS drug GM604

In a huge victory for ALS sufferers, FDA granted Genervon Biopharmaceuticals a fast track designation for its first in class highly effective multi-target master regulator biotechnology drug GM604 for ALS. FDA said it met the necessary criteria.

Genervon has received many inquiries from ALS patients interested to participate in the FDA approved IND GM604 clinical trial for ALS (clinicaltrials.gov NCT01854294). GM604's mechanisms of action against ALS involve 12 pathways and up to 22 biological processes. It modulates over 80 specific ALS related genes interactively, systemically and dynamically.

In order to stimulate the diseased and compromised axonal transport system and delay ALS onset and death of neurons, GM604 regulates 25 genes in this pathway alone. Further scientific details and informative videos can be found at www.genervon.com.

In the 1990s, Genervon hypothesized that neurological and neurodegenerative diseases involve the interplay of multiple targets and processes in an interactive dynamic mechanism/network. Most researchers/experts in the field have now confirmed that ALS is a complex, multiple targets and multi-system neurodegenerative disorder. That is one of the main reasons why single target drugs have uniformly failed in previous clinical trials.

Genervon scientists using breakthrough proprietary biotechnologies discovered GM604 which is an endogenous, multiple target, master regulator signaling peptide. Highly expressed in week 9 of human embryonic/fetal gestation, GM604 plays a significant role in nervous system development, protection and correction.

The impressive effects of GM604 are consistent with the role of a master regulator of the nervous system in embryonic development. Because ALS has many diverse forms with different pathogeneses, previous single target drug trials tried to restrict the enrollment to a small selective uniform segment of patients. Since GM604 is a multiple target biotechnology drug, able to control multiple ALS genes through multiple pathways, Genervon's FDA approved fast track clinical trial is broadly inclusive.

FDA's fast track designation will expedite drug approval process to treat ALS.