ALS Cure Drug Created by Pasadena Company Gets Positive Rating by European Authorities

Pasadena-based Genervon Biopharmaceuticals announced Tuesday that its very promising ALS treatment has successfully passed the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) phase.

ALS, or amyotrophic lateral sclerosis, is a progressive neurogenerative disease that affects nerve cells in the brain and spinal cord and could lead to a loss of the brain’s ability to initiate and control muscle movement. Genervon’s treatment for ALS is called the GM604.

In a press statement, Genervon said EMA’s COMP has issued a positive opinion saying GM604 has met the orphan drug designation criteria and is now awaiting final approval for Orphan Drug status across the European Union.

In 2014, the FDA granted the same orphan drug designation status for GM604 in the United States.

“We are pleased that the EMA’s Committee of expert scientists considers GM604 to be a promising and exciting treatment for ALS,” said Dorothy Ko, Genervon’s Chief Operations Officer. “Orphan Drug status will give a stronger basis for ALS sufferers across the European Union who are seeking to access GM604 treatment under EU member countries’ Compassionate Use or Individual Use under Temporary Authorization for Use.”

Genervon Biopharmaceuticals says it has been providing the treatment to individual ALS patients in 5 countries across 5 continents since June 2015 under their government health agencies’ Named-patient Special Access schemes.

Genervon will soon be sending out further details about its lessons learned from treating the broad base of international patients with GM604. The company is also looking forward to working with the EMA to benefit from the advantages of an Orphan Drug designation.

Genervon Biopharmaceuticals LLC has its headquarters office at 1055 E. Colorado Blvd. in Pasadena. To learn more about the company and GM604, visit www.genervon.com.