Printer Friendly

CORTECH ANNOUNCES FILING OF AMENDMENT TO BRADYCOR IND FOR TREATMENT OF BURN PATIENTS

 DENVER, Aug. 19 /PRNewswire/ -- Cortech Inc. (NASDAQ: CRTQ) has filed an amendment to its investigational new drug (IND) application for Bradycor(TM) with the U.S. Food and Drug Administration in order to initiate clinical trials in patients with moderate and severe burns, David K. Crossen, president and chief executive officer, announced today.
 This filing will allow Cortech to initiate a pilot double-blind, placebo-controlled study in burn patients. The study will be conducted in a small number of centers in the United States and will be designed to investigate the effect of Bradycor on mortality, organ dysfunction, edema (swelling) and other measures of outcome in these patients.
 Because burn patients vary greatly in their risk of death and organ dysfunction depending on the size of the burn and other factors, the study will use risk stratification and adjustment methodologies to account for the differences in risk. In this study, Bradycor will be administered as a continuous infusion for seven days.
 By filing this amendment, Cortech has laid the groundwork to initiate its third Phase II trial with Bradycor. If successful, the pilot study would be followed by additional studies to confirm its clinical benefit and safety in larger groups of patients.
 The company began enrollment of systemic inflammatory response syndrome (SIRS) patients with presumed sepsis in January; that 500-patient study is ongoing. The company also filed an amendment to the IND in May to investigate Bradycor in head injury patients. Despite reaching these milestones, Cortech can offer no assurance that its compound will progress to successful product launches or product revenues.
 Bradycor, also known as CP-0127, is a bradykinin antagonist that blocks the activity of bradykinin, a mediator produced in response to many forms of tissue injury including infections, trauma and burns. Once produced, bradykinin can cause low blood pressure or hypotension, vascular leak, tissue swelling or edema, pain and other symptoms of inflammation.
 Cortech is a Denver-based biopharmaceutical company that is developing a variety of therapies for inflammatory diseases, allergies and selected autoimmune diseases. Shares of the publicly traded company are listed as CRTQ on NASDAQ.
 -0- 8/19/93
 /CONTACT: David K. Crossen or Timothy C. Rodell of Cortech, 303-650-1200/
 (CRTQ)


CO: Cortech Inc. ST: Colorado IN: MTC SU:

BB -- DV002 -- 4224 08/19/93 10:03 EDT
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Aug 19, 1993
Words:380
Previous Article:TO BUSINESS EDITO
Next Article:DAVSTAR INDUSTRIES LTD. SIGNS MULTIYEAR DISTRIBUTION AGREEMENT FOR CEN-SLIDE(R) IN BRAZIL
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters