NeuroNova initiates a first-in-human study with a potential treatment for patients with ALS

Stockholm, Sweden and Leuven, Belgium, December 1, 2008 - NeuroNova, a privately held Swedish biopharmaceutical company pioneering treatments for disorders of the central nervous system, has received regulatory approval by the Federal Agency for Medicines and Health Products in Belgium to initiate a first-in-human study with the drug product sNN0029 in patients with Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig´s disease).

ALS is one of the most devastating diseases of the central nervous system and is characterized by progressive degeneration of motor neurons in the brain and spinal cord. This leads to muscle weakness that affects the limbs as well as muscles involved in speech and swallowing. The mean survival from diagnosis is 30 months. The need for an effective treatment is very high.

NeuroNova´s drug product sNN0029 contains the naturally occurring protein VEGF (Vascular Endothelial Growth Factor). Researchers of VIB in Leuven, Belgium have shown that administration of this protein caused improved muscle strength and prolonged survival in an animal model of ALS. These preclinical studies used direct administration of the protein VEGF into one of the fluid filled cavities of the animals´ brains (intracerebroventricular administration). Disturbances in the ability to produce VEGF have been demonstrated in patients with ALS which further supports the hypothesis that treatment with the drug product sNN0029 may slow disease progression. NeuroNova has licensed the use of VEGF for ALS from VIB, and has performed the additional preclinical development required to initiate clinical trials.

The first-in-human study will investigate the safety and tolerability of intracerebroventricular administration of sNN0029 to patients with ALS using an implanted catheter and pump. If the treatment is demonstrated to be safe and well tolerated, subsequent studies will focus on therapeutic efficacy. "We are excited to initiate clinical testing of our drug product, and we hope it may offer prolonged survival to patients with this devastating disease", says Markus Jerling, Chief Medical Officer at NeuroNova. "There is an immense need for an effective treatment in ALS, and the preclinical data for sNN0029 looks very promising", says Wim Robberecht, Professor of Neurology at the University Hospital Leuven, Belgium, where the clinical trial will be conducted.

For more information on this project, please contact:

Markus Jerling, NeuroNova AB Tel: +46 (0) 8 786 0900, markus.jerling@neuronova.com

Anders Haegerstrand, NeuroNova AB Tel: +46 (0) 8786 0900, anders.haegerstrand@neuronova.com ulf.ljungberg@neuronova.com

Wim Robberecht, VIB, UZ Leuven Tel: +32 16 33 07 70 ( +32 486 09 85 69)

For more information on NeuroNova, please contact:

Ulf Ljungberg, NeuroNova AB Tel: +46 (0) 8 786 0900, ulf.ljungberg@neuronova.com

For more information on VIB (Flanders´ Institute of Biotechnology), please contact:

VIB communication service: Tel: +32 9 244 66 11

NeuroNova (www.neuronova.com) is a Swedish bio-pharmaceutical company based in Stockholm, Sweden. NeuroNova has two drug candidates nearing clinical development for Parkinson's disease and ALS. NeuroNova works with neurogenesis and neuroprotection for the treatment of several currently incurable neurodegenerative diseases, including Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis (ALS) and Huntington's disease.

Note for the editor

The fundamental preclinical VEGF research was done by Diether Lambrechts, Wim Robberecht and Peter Carmeliet of the VIB Vesalius Research Center, K.U.Leuven, under direction of Peter Carmeliet (www.vib.be/Research/EN/Research+Departments/Vesalius+Research+Center, www.vib.be/Research/EN/Research+Departments/Vesalius+Research+Center/Peter+Carmeliet )