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Executive Summary

UPJOHN "LAZAROID" TIRILAZAD TO BE INCLUDED IN NASCIS III study to look at the effectiveness of steroid treatment for acute spinal injury under a protocol recently submitted to the National Institutes of Health. The protocol for the third National Acute Spinal Cord Injury Study was submitted to NIH by principal investigator Michael Bracken, Yale University, and awaits approval. Although the protocol is subject to change, the proposed randomized, double-blind trial is expected to include two arms of varying dosages of Upjohn's Solu-Medrol (methylprednisolone) and one with Solu-Medrol and tirilazad. As proposed, the trial would include approximately 500 patients from 14 centers. Patients age 14 years or older with spinal cord injuries suffered within the previous 12 hours, but no other serious injuries, would be eligible for entry into the trial. Results from NASCIS II, published in the May 17 New England Journal of Medicine, showed that in patients with acute spinal cord injury, methylprednisolone treatment with a bolus injection of 30 mg per kilogram of body weight given over 15 minutes followed 45 minutes later by a maintenance dose of 5.4 mg per kilogram of body weight administered over the next 23 hours "improves neurologic recovery" when initiated in the first eight hours after injury. The earlier NASCIS I trial, published in 1984, compared a 1,000-mg infusion of methylprednisolone sodium succinate with a 100-mg dose of methylprednisolone given as a bolus and daily thereafter during the next 10 days and found no significant differences in outcome. Phase I trials of tirilazad, a 21-amino steroid formerly known as U-74,006F, were completed in late 1989, and the drug is on FDA's fast-track, expedited approval program for treatment of head injuries ("The Pink Sheet," Oct. 16, 1989, p. 8). Over 100 head injury patients have been enrolled in a 10-center Phase II trial involving 120-150 patients that began in late 1989. During a Nov. 9 technology transfer meeting at NIH, Upjohn VP-Clinical Development and Medical Affairs Lawrence Olanoff reported that the company is currently conducting pilot Phase II trials, begun last spring, in anticipation of supplying tirilazad during the NASCIS III study. Currently, eight subjects with spinal cord injuries are enrolled in the three-center trial with a protocol target of 16 patients. Upjohn is also conducting a Phase II placebo-controlled efficacy study with tirilazad in 120 hemmorhagic stroke patients. That 12-center Canadian study began in the spring of 1989. Thus far, 17 patients have been enrolled at the first of three dosage levels. When 30 patients have received the drug and 10 have received placebo, the trial will progress to the second of three drug levels. As a secondary endpoint, the study looks at information on the effect of tirilazad in reducing cerebral vasospasm, which causes chronic neurological deficits in some stroke patients. Olanoff said after the meeting that upon completing the Phase II trials, Upjohn is looking to supply tirilazad in a definitive Phase III study program in hemorrhagic stroke patients with the cooperation of the NIH. A second, Phase II pilot trial of tirilazad in ischemic stroke patients is slated to begin in January 1991, pending FDA approval of an IND. Upjohn plans to submit the IND at the end of November. The proposed trial would test the drug in roughly 100 subjects in four U.S. centers.

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