Ethics approval and pharmaceutical production in place for clinical trial of NeuroSTAT®

On June 10, 2009 NeuroVive received ethical approval for the clinical study which will compare NeuroSTAT® with Novartis Sandimmune® in 58 healthy subjects. Production of NeuroSTAT® for the clinical study has passed all quality controls and release was obtained May 28.

CEO Eskil Elmér comments:

The clinical trial protocol has been developed and finalized in cooperation with one of the world's leading CRO's and external experts with experience from the U.S. and European regulatory authorities. The study, which will compare NeuroSTAT® with Novartis product Sandimmune® injection will include 58 healthy individuals with different gender and ethnic background. This study is one of the main components of the development of NeuroVive’s first pharmaceutical product for clinical use. If the study is successful it will open the opportunity to outlicense the product NeuroSTAT® for existing indications for i.v. cyclosporin-A (such as immunosuppression) and to make NeuroSTAT® available for clinical trials.

NeuroSTAT®

NeuroSTAT® is an intravenous cyclosporin-A lipid emulsion which is free from cremophore EL (castor oil) and alcohol. Cremophore EL has been reported to cause hypersensitivity reactions (anaphylaxis) in some patients being treated. The introduction of a cremophore EL-free intravenous cyclosporin-A lipid emulsion will provide a safer alternative to patients similar to the introduction of cremophor-free Pacitaxel (Taxol) and Propofol (Diprivan) products.

For more information contact:

Eskil Elmér
CEO and CSO, Neurovive Pharmaceutical AB (publ)

Phone: + 46 (0)46-288 01 10
eskil(punkt)elmer(snabel-a)neurovive(punkt)se

NeuroVive is involved in research and development into drugs which protect nerve cells. The company is now conducting clinical trials in humans with the product NeuroSTAT®, and its business also includes advanced research and development of other variants of cyclophilin-D-inhibiting cyclosporines and studying new ways of transporting these drugs across the blood-brain barrier to the central nervous system.

NeuroVive intends to license products to major pharmaceutical companies for registration and marketing. The company will derive its income partly from fixed payments and partly from ongoing royalty income from sales of licensed products.