[May 03, 2016]

GM604 to Be Granted "Orphan Drug" Status in Europe

Genervon Biopharmaceuticals today announced that its very promising ALS treatment has successfully passed the EMA's (News - Alert) "COMP" phase. The Committee for Orphan Medicinal Products (COMP) has issued a positive opinion that Genervon's GM604 has met the orphan drug designation criteria and is now awaiting final approval for Orphan Drug status across the European Union. "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, Chief Operations Officer at Genervon. "As well as adding weight to the 2014 decision by the FDA to grant the same orphan drug designation status in the United States, Orphan Drug status will give a stronger basis for ALS sufferers across the EU who are seeking to access GM604 treatment under EU member countries' Compassionate Use or Individual Use under Temporary Authorization for Use (ATU)."

GM604 is an endogenous embryonic stage signaling master regulator of the human nervous system. It is novel and may be curative for ALS. Genervon's innovative hypothesis, drug discovery, drug development and clinical trials for GM604 have been in progress for the last 20 years. http://www.genervon.com/genervon/PR20160429.php

Since June 2015 Genervon Biopharmaceuticals has been providing GM604 upon the requests of individual ALS patients in 5 countries across 5 continents under their government health agencies' Named-patient Special Access schemes. Genervon has completed the randomized double-blinded GALS-001 trial with GM604 in ALS patients and submitted all clinical trial reports to the FDA. While a phase 3 trial is being planned, Genervon's team remains absolutely committed to finding a faster way of demonstrating the safety and effectiveness of GM604 and getting it to ALS patients who simply can't wait-out the 3 to 5 years needed for Phase 3 trials.

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 European Medicines Agency to benefit from the advantages of an Orphan Drug designation.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160503005834/en/

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