A Phase II pilot study of Cortech Inc.'s CE-1037, a parenteralelastase inhibitor, for acute respiratory distress syndrome has beensuspended after partner Hoechst Marion Roussel said safety concernswith the drug surfaced in recent animal studies.
Joseph Turner, chief financial officer with Denver-based Cortech,said Hoechst Marion Roussel, of Frankfurt, Germany, also has endedtheir collaboration on CE-1037, returning all rights to the product.
Turner did not know details of the preclinical studies Thursday.Frankfurt-based Hoechst AG, parent of Hoechst Marion Roussel,took over development of CE-1037 in 1995 when the German drugmaker acquired Marion Merrell Dow, of Kansas City, Mo.
No adverse events have occurred in any clinical trials with CE-1037,Turner added. Patients were being enrolled in the Phase II trial foracute respiratory distress syndrome when it was suspended. A reviewof the preclinical safety data will be conducted before deciding howto proceed.
Another Phase II trial of the elastase inhibitor for cystic fibrosis hasbeen completed and results are being analyzed.
Turner said Cortech received $1 million in 1996 from Hoechst insupport of the CE-1037 program.
Two months ago SmithKline Beecham plc, of London, suspended aPhase II trial of Cortech's Bradycor after safety concerns were raisedin rat studies being conducted for the pharmaceutical firm by anoutside contract research organization.
As with CE-1037, Bradycor, a bradykinin inhibitor, was notassociated with any adverse reactions among patients in any clinicaltrial. The Phase II study of Bradycor for prevention of brain damagefrom head injuries was nearly completed when it was stopped.
Turner said the trial, which had enrolled 130 of 160 patients, will notbe resumed. Bradycor's performance will be evaluated based on thedata already collected and results are expected in the first quarter of1997.
The preclinical safety problems with Bradycor remain unexplained,he added.
Cortech's stock (NASDAQ:CRTQ) closed Thursday down $0.188 to$1.437. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.