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KETOCYTONYX COMMENCES PHASE I STUDY FOR NEUROPROTECTANT KTX 0101
KetoCytonyx, Inc, a pharmaceutical development company focused on cell protection therapeutics, today announced that a Phase I clinical study has begun on KTX 0101, its lead therapeutic with a target indication of prevention of cognitive impairment in patients undergoing Coronary Artery Bypass Graft surgery. The Phase I study will enrol up to 20 healthy volunteers who will receive an intravenous infusion of KTX 0101 in a dose-escalation design up to the maximum dose of 300 mg/kg, which will be infused intravenously over 24 hours. The objective of the study is to assess tolerability and drug pharmacokinetics. Measurements of potential pharmacodynamic effects will also be obtained in the study. “The commencement of this clinical study is an important milestone for the development of KTX 0101 and for the Company,” commented Dr Keith Martin, President of KetoCytonyx. Pre-clinical studies, carried out by Shimizu Pharmaceuticals Co, Ltd and others, showed promising neuroprotectant effects. In the past 18 months KetoCytonyx has advanced development of KTX 0101 significantly with manufacturing process, dose and formulation development work. “Now that we have received approval for our clinical study from the UK regulatory agency, we plan to be in a position to assess neuroprotectant effects in patients undergoing CABG surgery early next year,” added Dr Martin. 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. It is estimated that 1-1.5 million CABG surgery procedures per year are conducted in North America and Europe. There are currently no therapeutics available to provide neuroprotection during and following the procedure, yet it is estimated in published papers that 26 86 per cent of patients experience some cognitive impairment. This can range from minor abnormalities to complete loss of short-term memory or, in up to 5 per cent of cases, stroke. NeuroInvest estimates the market for neuroprotectants in the CABG patients to be $1-2 billion.
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