NeuroNova´s drug candidate sNN0029 for ALS/Lou Gehrig´s disease receives orphan designation by the European Medicines Agency
Stockholm, Sweden, February 8, 2010 – NeuroNova, a privately held Swedish biopharmaceutical company pioneering treatments for disorders of the central nervous system, has received orphan designation by the European Medicines Agency 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 wholly owned 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 presently being initiated.
Per Almqvist, NeuroNova AB Tel: +46 (0) 8 786 0900 Email: firstname.lastname@example.org
Ulf Ljungberg, NeuroNova AB Tel: +46 (0) 8 786 0900 Email: email@example.com
NeuroNova (www.neuronova.com) is a Swedish bio-pharmaceutical company based in Stockholm, Sweden. NeuroNova has two drug candidates in clinical development for Parkinson’s disease and ALS. NeuroNova believes that therapeutic neurogenesis and neuroprotection can revolutionize the treatment of several currently incurable neurodegenerative diseases, including Parkinson’s disease, Alzheimer’s disease, amyotrophic lateral sclerosis (ALS) and Huntington´s disease.