VistaGen Therapeutics, Inc. announced publication of preclinical data suggesting that AV-101, its lead drug candidate for treatment of neurological disorders, may be useful for treating Parkinson’s disease. The data from studies conducted by VistaGen and collaborators in Dr. Sophie Erhardt’s laboratory at the Karolinska Institute in Sweden appeared in the peer-reviewed Journal of Neuropharmacology*. VistaGen is a platform-enabled biopharmaceutical company applying embryonic stem cell technologies to discover, develop and commercialize small molecule drugs and protein therapeutics for diabetes and neurological disorders.
AV-101 is a first-in-class prodrug that regulates critical glutamate signaling pathways in the brain, including those associated with the stimulation of neurons that produce dopamine. In the reported studies, animal models were used to measure the activity of dopaminergic (DA) neurons in the brain following the systemic administration of AV-101 (4-chlorokynurenine), which is converted in the brain into 7-chlorokynurenic acid, one of the most potent and selective regulators of the glycine-site of the NMDA receptor.
Treatment with AV-101 was found to increase the “firing rate” and “burst firing” activity of DA neurons by 27% and 61%, respectively. These are two key indicators of DA neuron function that are associated with the large release of dopamine that is critical to many important neuronal signaling events in the brain. Reduced production of dopamine is characteristic of Parkinson’s disease, and is a major cause of the symptoms of the disease.
“Besides observing that AV-101 can stimulate the activity of neurons that produce dopamine, preliminary data suggest that AV-101 also may activate additional, quiescent DA neurons. We have not seen this type of dual activity in any other drug,” said H. Ralph Snodgrass, Ph.D., VistaGen’s President and CEO. “We are on track to submit an IND to the FDA in the first quarter of 2008 for clinical development of AV-101 for treatment of neuropathic pain and epilepsy. With the publication of these latest study results, we hope to extend our clinical studies to include Parkinson’s disease.”
Close to four million persons worldwide currently suffer from Parkinson’s disease with an estimated $2 billion spent on drug therapy annually.
