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 DENVER, Dec. 21 /PRNewswire/ -- Cortech Inc. (Nasdaq: CRTQ) today recapped its 1994 accomplishments and discussed certain decisions it has made to modify its development programs for 1995.
 In summary, in 1994 the company completed two Phase 2 trials for its lead bradykinin antagonist, Bradycor(TM), in the indications of sepsis and head trauma, respectively. While the initial Phase 2 trial in sepsis did not show a clinically meaningful improvement in the primary endpoint of 28-day survival among the entire study population, the data did show a statistically significant improvement in this outcome in treated patients with pure Gram-negative infections. The company also obtained statistically significant results in its pilot Phase 2 head trauma study.
 On other fronts, Cortech advanced two additional lead compounds toward clinical trials and has taken actions to focus its activities on its most promising opportunities.
 Products Under Development
 Cortech completed enrollment in its first Phase 2 study in April 1994. In that trial, 504 patients with systemic inflammatory response syndrome (SIRS) and presumed sepsis received placebo or one of three doses of Bradycor via a three-day intravenous infusion. In the primary data analysis, announced July 21, the drug did not demonstrate a clinically meaningful reduction in overall risk-adjusted 28-day survival -- the trial's primary endpoint. However, prospectively defined analyses of the trial data showed that the drug effected a statistically significant improvement in risk-adjusted 28-day survival in the subgroup of patients with pure Gram-negative infections.
 All of the efficacy analyses of the initial Phase 2 sepsis trial's data have now been completed, and the data show a strong trend toward improvement in 7-day mortality in all treated patients and trends toward improvement in 28-day mortality in treated patients in some certain other subgroups. However, with the exception of the Gram-negative subgroup, none of these trends achieved statistical significance. Bradycor showed no adverse effect on survival in any of the analyzed subgroups and, to date, no safety issues have been raised in any of the Bradycor trials.
 A single-center, pilot Phase 2 trial in patients with head trauma yielded statistically significant improvements in three measurements. The 20-patient, single-blind, placebo-controlled study demonstrated that patients who received Bradycor for seven days showed statistically significant: 1) reduction in peak intracranial pressure (ICP); 2) protection against deterioration of neurological function as measured by the Glasgow Coma Score; and 3) decreased surgery required to relieve increased ICP. A full presentation of the head trauma trial data is scheduled to be made April 24 at The American Association of Neurological Surgeons' Annual Meeting in Orlando, Fla.
 Based on the data acquired to date and its currently available resources, Cortech has made a number of decisions in regard to its Bradycor development program.
 First, Cortech will expand its second, ongoing Phase 2 SIRS/sepsis trial. In the second trial, begun in May, patients receive placebo or Bradycor for seven days (versus three days in the earlier study). The study was originally designed for 100 patients, but has been expanded to enroll up to 250 in order to increase the likelihood of confirming the encouraging results seen in the first trial. Cortech now anticipates completing enrollment around the end of the first quarter of 1995 with data expected to be announced around mid-year. The company does not anticipate initiating any new sepsis trials without first securing additional resources.
 Second, the company expects to proceed with a multi-center trial in patients with head trauma. Design of the trial is underway, and Cortech anticipates beginning enrollment early in 1995.
 Third, the company has elected to stop enrollment in its ongoing burns trial due to slow patient enrollment and in order to focus its resources elsewhere.
 Fourth, at this time the company is continuing enrollment in its multiple trauma trial. A further determination regarding the future conduct of this trial will be based upon trial progress and will take into consideration factors of timing and efficient application of company resources.
 Last, the company will not initiate a study in the near-term for patients with pancreatitis, another indication that potentially could be treated with a bradykinin antagonist. While preclinical data in this indication have been encouraging, Cortech's management intends to focus its efforts and resources for advancing Bradycor on head trauma and sepsis for the near-term.
 Cortech filed an Investigational New Drug application (IND) in the third quarter to begin clinical trials with CE-1037, its lead elastase inhibitor, which is being developed in conjunction with Marion Merrell Dow Inc. The company anticipates having Phase 1 safety study data by mid-1995.
 Cortech anticipates that the development agreement with Marion Merrell Dow will be renewed, and Cortech will continue to manage development of the compound. The initial target indication is acute respiratory distress syndrome (ARDS) with testing for genetic emphysema and cystic fibrosis to follow.
 During 1994, Cortech completed a royalty buyout with the Research Foundation of the State University of New York (RFSUNY) for CE-1037, which was discovered as a result of a joint research project between the university and Cortech. Under the buyout agreement, Cortech will receive all royalties due from Marion Merrell Dow (8 to 10 percent) should CE-1037 be marketed.
 Cortech now anticipates filing an IND in the first quarter of 1995 for its lead antigen-specific immunomodulator, Sulfasim(TM). This compound has been designed for the potential prevention and treatment of sulfamethoxazole allergies in AIDS patients. The company anticipates commencing Phase 1/2 studies in the second quarter of 1995 and completing enrollment by year's end.
 In light of its revised clinical development plans for Bradycor and the prioritization of pipeline projects, Cortech has been working to reduce its staffing levels. In total, through attrition and elimination of outside contractors and selected permanent positions, the company has achieved an overall contraction in staff of 39 full-time equivalents, or approximately 19 percent of total employment, over the past four months. The company believes that its staffing level of 169 employees is appropriate for the current programs.
 CEO Search
 In March 1994, Cortech's President and Chief Executive Officer, David Crossen, resigned and Paul Jerde, a member of Cortech's board since 1987, has been serving as acting chief executive officer since. The board of directors is conducting a search for a permanent chief executive officer.
 The Company
 Cortech is a Denver-based biopharmaceutical firm that is developing three novel classes of drugs for the treatment of inflammatory and immunologic disorders. Cortech cannot offer any assurances that early test results predict ongoing or future trial successes or that any of its products will be successfully developed or commercialized.
 -0- 12/21/94
 /CONTACT: Paul J. Jerde, vice chairman and acting CEO, or Joseph L. Turner, VP Finance and Administration and CFO, or Timothy C. Rodell, M.D., executive VP, Operations and Product Development, 303-650-1200, all of Cortech/

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

BB-MO -- DVFNS1 -- 6889 12/21/94 07:34 EST
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Publication:PR Newswire
Date:Dec 21, 1994

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