Upjohn Co. has halted Phase I clinical trials of Biopure Corp.'sblood substitute due to "transient" medical effects.
The trials of Biopure's Hemopure began on March 4 andstopped last week, said Biopure spokesman Andy Plesser.
Neither company would specify why the trials were stopped,adding that the results were preliminary and proprietary.
The Food and Drug Administration agreed that the trials behalted, said Plesser. Upjohn is conducting additional tests anddoing further data analysis for FDA review.
Hemopure, a reconstituted hemoglobin preparation purifiedfrom bovine blood, is Biopure's major product, said Plesser. Thecompany is also testing a related compound, Oxyglobin, inveterinary applications.
Upjohn, of Kalamazoo, Mich., has agreed to spend up to $154million with Biopure for clinical development of Hemopure.Upjohn will have worldwide marketing rights except forEurope. Biopure, a privately held company in Boston, isresponsible for manufacturing the product.
Upjohn spokesman John Lambrechts and Plesser said thecompanies expect the trials to resume after the review.
-- Carol Talkington Verser, Ph.D. Special to BioWorld
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