NeuroVive: NeuroVive Doses Last Patient In Clinical Trial Of Cremophor(R)- Free Cyclosporine I.v. NeuroSTAT(R)

Main Category: Neurology / Neuroscience
Also Included In: Clinical Trials / Drug Trials
Article Date: 05 Nov 2009 - 3:00 PDT

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NeuroVive Pharmaceutical AB, of Lund, Sweden, announced that on November 3, 2009 it completed the clinical phase of its study investigating tolerability and pharmacokinetics of the cremophor®-free cyclosporine i.v. formula NeuroSTAT®.

CEO Eskil Elmér comments that "This study in 52 healthy subjects is a direct comparison of NeuroVive's injectable cyclosporine product NeuroSTAT® with Novartis's product Sandimmune® Injection. This is an important milestone in the development of NeuroVive's first pharmaceutical product for clinical use in patients with acute brain damage. Further, if the final analysis of the study is successful it will open the opportunity to develop or outlicense the product NeuroSTAT® for existing indications for intravenous cyclosporine A (such as immunosuppression). We expect to make NeuroSTAT® available for clinical trials and sales on a named-patient basis."

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."

Chairman Greg Batcheller comments "The completion of this trial represents an important step in the development of NeuroSTAT®. It sets the stage for a next round of financing that will eventually take us into clinical trials in traumatic brain injury patients in Europe and the US."

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

NeuroVive Pharmaceutical AB is a Swedish research and development company. NeuroVive's primary mission is to develop drugs which protect nerve cells. The company is currently conducting clinical trials in humans with the product NeuroSTAT®. In addition to introducing NeuroSTAT® as the first cyclophilin-D-inhibiting mitochondrial protectant, NeuroVive is researching and developing variants of cyclophilin-inhibiting cyclosporines and new ways of transporting these drugs across the blood-brain barrier to the central nervous system.

NeuroVive Pharmaceutical AB shares are listed on the Swedish trading platform AktieTorget (www.aktietorget.se). The AktieTorget market is focused on emerging, entrepreneurial businesses and offers an electronic trading system supplied by the OMX Nordic stock exchange in Stockholm, Sweden.

Source
NeuroVive Pharmaceutical AB

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