NeuroNova´s drug candidate sNN0029 for ALS/Lou Gehrig´s disease receives orphan drug designation by the FDA

Stockholm, Sweden, June 22, 2010 – NeuroNova, a privately held Swedish biopharmaceutical company pioneering treatments for disorders of the central nervous system, has received orphan drug designation by the US Food and Drug Administration (FDA) for its clinical candidate sNN0029 for patients with Amyotrophic Lateral Sclerosis (ALS), also referred to as Lou Gehrig´s Disease. This program is presently in clinical development phase I/II.

ALS is one of the most devastating diseases of the central nervous system and is characterized by progressive muscle weakness that may affect the limbs as well as muscles involved in speech and swallowing. The mean survival from diagnosis is 30 months with wide variation. The need for an effective treatment is very high.

NeuroNova´s drug candidate sNN0029 contains very low doses of the naturally occurring protein VEGF (Vascular Endothelial Growth Factor) which has been shown to cause improved muscle strength and prolonged survival in an animal model of ALS, using direct administration of VEGF into one of the fluid filled cavities of the brain. Disturbances in the ability to produce VEGF have been demonstrated in patients with ALS which further supports the hypothesis that sNN0029 administration may slow disease progression.

NeuroNova has licensed the use of VEGF for ALS from the Flanders Institute of Technology, Belgium, as well as from Genentech, Inc., a member of the Roche Group. NeuroNova and Genentech have earlier entered into a License and Option Agreement for the US, Canada and Mexico.

The ongoing phase I/II study is investigating the safety and tolerability of intracerebroventricular administration of sNN0029 to patients with ALS using an implanted catheter and pump. The first open part of the trial has been completed, and a second placebo-controlled, double-blind part of the same phase I/II study is ongoing. NeuroNova has earlier received orphan drug designation for this program by the European Medical Agency EMA.

For more information on this project, please contact:
Per Almqvist, NeuroNova AB Tel: +46 (0) 8 786 0900 Email: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

For more information on NeuroNova, please contact:
Ulf Ljungberg, NeuroNova AB Tel: +46 (0) 8 786 0900 Email: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it