The primary aim of the trial is to determine the safety and tolerability of the anti-inflammatory compound over a range of doses in healthy volunteer subjects. The trial will be conducted at the Clinical Pharmacology Research Unit at Parexel, Northwick Park Hospital in the United Kingdom. CTI's Phase I trial marks the first time the compound will be administered intravenously to humans.
"This study encompasses the achievement of several milestones," said CTI President and CEO Paul Rubin, M.D. "It marks CTI's first clinical trial in the Company's brief history and is especially notable because CTI-01 was discovered by Mitch Fink M.D., one of the company's founders. The speed and efficiency which with which we have advanced CTI-01 into human trials reflects the dedication and initiative of our entire team."
CTI-01 is a cytoprotective compound that reduces vascular and organ damage following severe insults to the body such as surgical and non-surgical trauma, pancreatitis or overwhelming infection. The small molecule has demonstrated potent anti-inflammatory and tissue protection activity in multiple animal treatment models of disease including pancreatitis, vascular reperfusion injury, hepatitis and endotoxemia. CTI-01 has the potential to prevent and reverse complications in patients undergoing serious operations or multi-organ failure associated with life- threatening acute conditions including shock, myocardial infarction, acute pancreatitis, burns, stroke or acute drug allergies.
Approximately $180 billion is spent each year to treat patients with these life threatening conditions, according to a study conducted by researchers at the University of Pittsburgh School of Medicine and Johns Hopkins University School of Medicine.
To assess the anti-inflammatory and anti – cytokine properties of CTI-01, subjects will be administered endotoxin, a cell wall lipopolysaccharide of Gram-negative bacteria that has been shown to induce an inflammatory response in humans and other species.
"This Phase I study gives us a glimpse into the potential anti-inflammatory effects of this compound," said Walter Newman, Ph.D., CTI's chief scientific officer. "The trial allows us to evaluate earliest responses activated after exposure to endotoxin as a surrogate marker to identify promising agents with potential as anti-inflammatory drugs."
About Critical Therapeutics Critical Therapeutics, Inc. is a privately held biopharmaceutical company focused on critical care medicine. CTI's mission is the discovery, development and commercialization of novel therapies for the treatment of acute trauma, cardiopulmonary disease and infectious and inflammatory illness. In addition to CTI-01, the Company's current research and development portfolio includes the following therapeutic targets: HMGB-1, a pro-inflammatory substance identified as a mediator of TNF-associated tissue damage; and development of small molecule and vagal nerve stimulation approaches to treat inflammation. More information about CTI is available at http://www.criticaltherapeutics.com