Clinical trial commences with the cremophor-free cyclosporine i.v. NeuroSTAT®

On June 24, 2009, NeuroVive commenced clinical trials of NeuroSTAT® by screening the first trial subjects.

CEO Eskil Elmér comments:

This study in healthy subjects is a direct comparison of NeuroVive’s product NeuroSTAT® with Novartis product Sandimmune® injection, and is an important component in the development of NeuroVive’s first pharmaceutical product for clinical use in patients with acute brain damage. 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 and sales on a named-patient basis.

The study will be conducted by one of the world's leading CRO's, and will include 58 healthy individuals with different gender and ethnic background. The clinical part of the trial includes two dosings (NeuroSTAT® and Sandimmune, respectively) for each individual. The results of the study are expected in the autumn after the analysis of blood samples and statistical processing.

The study is entitled: "A study to compare the bioavailability and pharmacokinetics of cyclosporine after intravenous administration of NeuroSTAT®, a Cremophor® EL-free lipid emulsion, and Sandimmune® injection (a suspension of cyclosporine in Cremophor® EL) in healthy volunteers"

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 Paclitaxel (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.