ORTHO EPO CLINICAL RESULTS FOR PRE-DIALYSIS ANEMIA

Executive Summary

ORTHO EPO CLINICAL RESULTS FOR PRE-DIALYSIS ANEMIA, scheduled for publication in The New England Journal of Medicine, will show that erythropoietin (EPO) can be administered subcutaneously, as opposed to intravenously, without a loss in efficacy. University of Washington hematology division head John Adamson, MD, previewed the subcutaneous study results to a March 1 conference in Chicago co-sponsored by Communitech and Vector Securities. To date, most studies have used an intravenous route of administration for EPO but, Adamson said, "there is clearly no significant difference in the rate of response ]in hematocrit[ whether the patient receives 150 units/kg I.V. or 100 units/kg subcutaneously." The University of Washington researcher said "pharmacokinetic studies would suggest that subcutaneous doses will eventually be shown to be or will be more efficient on a dose per kilo basis -- at the same time giving a hematologic response." In Seattle, Adamson said, "we now have pre-dialysis patients receiving erythropoietin subcutaneously only twice a week and are maintaining a hemoglobin hematocrit in an acceptable range." Ortho has not yet filed a Product License Application for the blood growth factor product which it licenses from Amgen. In January, Ortho filed a preliminary injunction against its EPO partner for failure to file the PLA for the treatment of pre-dialysis and non-dialysis indications and supply Ortho with EPO as per their 1985 agreement ("The Pink Sheet" Feb. 6, T&G-8). Adamson commented on concerns about the use of EPO in pre-dialysis patients with declining renal function. The researcher said that "correcting the hematocrit with EPO has not resulted in an acceleration in the decline of renal function." He concludes that "consequently one of the reasons for not using EPO in ]pre-dialysis[ renal patients we can set aside." In another Ortho study underway at Vanderbilt University, patients with rheumatoid arthritis have been treated with EPO to reduce chronic anemia associated with inflammation. Of the 15 patients under study, "virtually all" experienced an increase in hematocrit, Adamson noted. "What has not been clear and what remains to be determined is whether these patients with rheumatoid arthritis have clinically benefited from having their hemoglobin come up," he remarked. Adamson suggested, however, that these patients may benefit from having their hematocrit "boosted" by EPO prior to elective surgery. Ortho is also studying EPO for autologous transfusions. In an Ortho-sponsored study on 180 patients, conducted at the Puget Sound Blood Center in Washington state, patients receiving EPO "had a hematocrit four points higher than placebo. This increase in hematocrit enabled 15 patients on EPO versus three on placebo to donate up to six units of blood." In addition, "the number of red blood cells per ml of blood was higher for those patients receiving EPO versus those patients receiving placebo," Adamson said.