Cortech Announces Extension of Suspension of Clinical Trials Of Bradykinin AntagonistDENVER, Nov. 4 /PRNewswire/ -- Cortech, Inc. (Nasdaq: CRTQ) today announced that it now expects a further delay prior to any re-initiation by SmithKline Beecham of the Phase II clinical trials of SB-238592 (Bradycor(TM)), a bradykinin bradykinin /brady·ki·nin/ (-ki´nin) a nonapeptide kinin formed from HMW kininogen by the action of kallikrein; it is a very powerful vasodilator and increases capillary permeability; in addition, it constricts smooth muscle and antagonist, for the treatment of traumatic brain injury Traumatic brain injury (TBI), traumatic injuries to the brain, also called intracranial injury, or simply head injury, occurs when a sudden trauma causes brain damage. TBI can result from a closed head injury or a penetrating head injury and is one of two subsets of acquired brain . The delay will allow the completion and analysis of additional animal tests. Cortech announced on October 23, 1996 that the trials had been suspended in response to the results obtained from a small pharmacokinetic study in rats in which unexplained mortality was seen. A toxicology study in rats was immediately conducted which failed to demonstrate any adverse effects. These data appeared to suggest that the results of the initial pharmacokinetic study were due to a technical issue in the preparation or administration of the dosing solutions rather than an effect of the drug substance itself. However, the initial pharmacokinetic study has now been duplicated, and an adverse effect on rats has again been observed, although no mortality occurred. A careful comparison of the methods used in the respective studies has revealed procedural differences that may ultimately be shown to factor in the results, but which require further evaluation before any conclusions can be drawn. Until this effect is more fully understood, the clinical trials will remain suspended. The North American trial has enrolled approximately 130 out of an intended 160 patients, and SmithKline Beecham is continuing to evaluate the best course for advancing the development of the drug. The suspension of the trials was not based on any adverse findings in the human clinical studies. Cortech is a Denver-based biopharmaceutical research firm focused on the discovery and early development of novel classes of drugs for the treatment of inflammatory disorders. SOURCE Cortech Inc.
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/CONTACT: Joseph L. Turner, CFO See Chief Financial Officer. of Cortech, 303-665-1200/ (CRTQ) CO: Cortech Inc. ST: Colorado IN: MTC mtc - A Modula-2 to C translator. ftp://rusmv1.rus.uni-stuttgart.de/soft/Unixtools/compilerbau/mtc.tar.Z. SU: AW-NL -- LAM035 -- 3612 11/04/96 07:00 EST http://www.prnewswire.com |
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