Critical Therapeutics launches Phase I clinical trial of anti-inflammatory compound

Cambridge, Mass., June 17, 2003 Critical Therapeutics, Inc. (CTI), a private biopharmaceutical company developing novel therapeutic products for critical care medicine, today announced the initiation of a dose-escalating Phase I clinical trial of its ethyl pyruvate compound, CTI-01.

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 Universit

Contact: Scott Solomon
Sharon Merrill Associates, Inc.

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