LUND, SWEDEN -- (Marketwire) -- 11/05/09 --
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.
Eskil Elmér, MD, PhD
CEO and CSO,
Neurovive Pharmaceutical AB
Biomedical Center, BMC D10
SE-221 84 Lund, Sweden
Tel.: +46 (0)733-919601
eskil.elmer@neurovive.com
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