Cortech Inc. on Thursday filed an amendment with the FDA toits investigational new drug (IND) application for Bradycor.
The amendment covers proposed clinical trials on Bradycor fortreating patients with moderate and severe burns.
The proposed study, a double-blinded, placebo-controlledPhase II trial, is designed to investigate the effect of Bradycoron mortality, organ dysfunction, edema and other measures ofoutcome in burn patients.
This will be the third indication for which Cortech of Denver isdeveloping Bradycor. The compound, also known as CP-0127, isan antagonist to bradykinin, a mediator produced in responseto many types of tissue injury, including infection, trauma andburns.
Cortech (NASDAQ:CRTQ) began enrolling systemic inflammatoryresponse syndrome (SIRS) patients with presumed sepsis in aclinical trial in January; that 500-patient study is ongoing. Thecompany also filed an amendment to the IND on May 10 toinvestigate Bradycor in head injury patients.
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