Phase I/II Results With Somatogen's rHb1.1

Phase I/II trial results of Somatogen's recombinant hemoglobin product rHb1.1 suggest that the product is safe and effective for use as a blood substitute. The results, from a trial in 18 patients who received the product during elective orthopedic surgery, will also form the basis for the design of Phase II trials which Somatogen will carry out with its development partner Eli Lilly.

14 of the 18 patients were administered a single intravenous dose of rHb1.1, with the highest dose being 25.6g, while the remaining four patients received saline. The patients were observed for a 24-hour period while they remained in hospital, and again at days two and seven of their recovery. No impairment of renal functions was observed, nor were there any serious gastrointestinal complaints (observed in the Phase I study) which required pharmacological intervention.

Somatogen and Lilly have begun Phase II trials of the product, in the form of two parallel programs designed to measure the safety of rHb1.1 in doses up to 100g, at Duke University in the USA.