FDA Approves Broadly Inclusive Phase IIa ALS Clinical Trial with GM604, a Biotechnology Innovation


Offering imminent hope for those with ALS, Genervon Biopharmaceuticals, an innovative biotechnology company announced today that it has received FDA approval and is now recruiting patients for its broadly inclusive ALS clinical trial.

In less than thirty days, FDA approved an ALS Phase IIa clinical trial for GM604 (FDA IND #118420). This trial is registered at clinicaltrials.gov #NCT 01854294. Recruiting Principle Investigators are Dr. Cudkowicz of Massachusetts General Hospital and Dr. Mitsumoto of Columbia Medical Center NY.

To participate, ALS patients should respond to recruitment by email: na2398@columbia.edu and/or, mparkinson@partners.org. Please visit www.genervon.com and copy your email to info@genervon.com. If you or someone you know has a life and death interest in this FDA approved biotechnology ALS trial, they should contact their doctors, favorite support groups and foundations for recruitment assistance.

Scientists now have enough evidence to confirm that ALS is a complex, multiple target and multi-system neurodegenerative disorder. That is one of the main reasons why clinical trials with single target drugs have uniformly failed. Genervon hypothesized in the 1990s that neurological diseases involve the interplay of multiple target processes in an interactive dynamic network.

GM604 discovered by proprietary biotechnology is a multiple target, master regulator and signal peptide. It is highly expressed in week 9 of gestation where it plays a significant role in nervous system development, protection and correction. GM604 is not a single target drug or a cocktail of single target drugs for ALS.

After fifteen years of successful research, eventual discovery, drug development and Phase 1 trials for safety, Genervon's GM604 modulates over 80 ALS related gene targets (efficacy and target biomarkers) interactively and dynamically, through up to 12 pathways and 22 biological processes. Target and efficacy biomarkers will be used as endpoints in this trial per FDA's recent recommendation to use biomarkers as surrogate endpoints.

Because ALS has many forms with different pathogeneses, previous single target drug trials restricted the enrollment to a small, selective segment of ALS patients. Since GM604 is a multiple target drug, able to control multiple ALS gene targets through multiple pathways, recruitment for this clinical trial is broadly inclusive.

Genervon Biopharmaceuticals is an innovative, clinical stage biotechnology company providing breakthrough biological drugs for some of the world's critical unmet medical needs.