Printer Friendly

CORTECH AMENDS IND TO INITIATE A PHASE II BRADYCOR TRIAL IN HEAD TRAUMA

 DENVER, May 10 /PRNewswire/ -- Cortech Inc. (NASDAQ: CRTQ) has filed an amendment to its investigational new drug (IND) application in order to initiate Phase II studies in head trauma patients, announced David K. Crossen, president and chief executive officer, today.
 Cortech began its first Phase II study with Bradycor(TM), known internally as CP-0127, in January 1993. That trial is a 500 patient multi-center study in patients with sepsis and the systemic inflammatory response syndrome (SIRS). Today's filing with the U.S. Food and Drug Administration (FDA) addresses the use of the compound in a second set of patients, those who have experienced head trauma.
 Bradycor 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, tissue swelling or edema, pain and other symptoms of inflammation. Because patient outcome and recovery in head trauma is frequently dependent on the degree of tissue swelling, the company believes a bradykinin antagonist may improve the outcome in these patients.
 The initial clinical trial in head trauma will be a small pilot study designed to measure the effect of Bradycor on intracranial pressure (ICP) and other measures of brain edema. If successful, this study would be followed by additional studies to confirm its clinical benefit and safety in larger groups of patients.
 In a Phase I study in normal volunteers completed in August 1992, Bradycor was shown to be safe with continuous intravenous infusions of up to three days at a wide range of doses. While Bradycor's Phase I safety results are encouraging, the successful completion of a Phase I safety study does not predict the outcome of a Phase II clinical trial. No assurance can be given at this time that the company's therapeutic approaches will lead to successful product launches and product revenues.
 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- 5/10/93
 /CONTACT: David K. Crossen of Cortech, 303-650-1200/
 (CRTQ)


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

MC -- DV011 -- 6528 05/10/93 13:53 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:May 10, 1993
Words:379
Previous Article:APRIL TRAFFIC REPORTED FOR MESA AIRLINES
Next Article:HUGHES SUPPLY, INC. ANNOUNCES THE ACQUISITION OF THE CAUSEY COMPANIES
Topics:


Related Articles
CORTECH STARTS PHASE II SIRS/SEPSIS STUDY
CORTECH RELEASES FIRST QUARTER RESULTS
TO BUSINESS EDITO
CORTECH ANNOUNCES FILING OF AMENDMENT TO BRADYCOR IND FOR TREATMENT OF BURN PATIENTS
CORTECH ANNOUNCES FILING FOR ADDITIONAL PHASE II SIRS/SEPSIS STUDY
CORTECH PRESENTS PHASE II SEPSIS TRIAL DATA
CORTECH ANNOUNCES POSITIVE RESULTS OF PHASE 2 HEAD TRAUMA TRIAL
CORTECH RECAPS 1994 ACTIVITIES
CORTECH BEGINS ENROLLMENT IN PHASE II TRAUMATIC BRAIN INJURY TRIAL
CoCensys to Initiate Large Phase II Trial in Migraine

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