KetoCytonyx Reports Positive Phase I Study of Neuroprotectant: KTX 0101 Shows Strong Safety and Preliminary Positive Pharmacodynamic Effects.

LONDON -- KetoCytonyx, Inc., a pharmaceutical development company focused on cell protection therapeutics, today announced the successful completion of a Phase I clinical study of KTX 0101, its lead therapeutic targeting prevention of cognitive impairment in patients undergoing coronary artery bypass graft (CABG) surgery.

Twenty healthy volunteers were enrolled into this dose-escalation study. KTX 0101 was found to be well tolerated by all volunteers with no serious adverse events reported. Drug pharmacokinetics were as predicted.

In addition, statistically significant changes, compared to placebo, seen in the electroencephalogram (EEG) recording indicated that KTX 0101 had a pharmacodynamic effect on the central nervous system. This effect is similar to that seen in patients when hypothermia was used to provide neuroprotection for patients undergoing CABG surgery and following head injury. Hypothermia has been reported to improve functional outcome following traumatic brain injury.

Dr. Keith Martin, President of KetoCytonyx, commented: "We are very pleased with the results of our first clinical study, which show that KTX 0101 was very well tolerated at all dose levels. The effect on the EEG recorded from the central nervous system also provides the first data in man to suggest a potential neuroprotectant effect. We are now planning the further clinical development of KTX 0101 to confirm safety and proof of principle as a neuroprotectant in Phase I b and Phase II studies."

Prof. Stanton Newman, Member of the KetoCytonyx Scientific Advisory Board, added: "The demonstration that the infusion of KTX 0101 has a significant effect on the EEG suggests that KetoCytonyx approach to neuroprotection for patients undergoing coronary artery bypass surgery holds great promise."

About KTX 0101

KTX 0101 (sodium beta-hydroxybutyrate) is one of a series of ketone bodies, key components of normal metabolic pathways. KTX 0101 acts as a "superfuel", an alternative energy system for cells when ischaemia reduces ATP production, as happens in CABG surgery for example. In addition to providing ketone bodies to the mitochondria to keep the cells alive, the ketone bodies also suppress free radical production and thereby increase the cell's ability to protect itself from damage.

About KetoCytonyx, Inc.

KetoCytonyx, Inc. is a pharmaceutical product development company dedicated to providing metabolic therapeutics based on the manipulation of fundamental metabolic pathways to protect cells in a wide range of acute and chronic neurodegenerative conditions. Using its core ketone body technology, the company is currently focused on developing products for prevention of cognitive impairment following cardiothoracic and orthopaedic surgery and for disease modification/symptom reduction in Parkinson's Disease with a new series of orally active compounds. KetoCytonyx was founded in November 2001 and closed Series A financing of $4.7 million from BTG, an intellectual property and technology commercialisation company, in March 2003.