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Executive Summary

SOMATOGEN RECOMBINANT HEMOGLOBIN BLOOD SUBSTITUTE to be studied by the U.S. Navy under an R&D contract to investigate lipid encapsulation of the company's product. The objective of the investigation is to see if the new delivery system will increase circulation half-life and extend shelf-life. Boulder, Colo.-based Somatogen announced the signing of a three-year contract with the Office of Naval Research on Oct. 30. The encapsulation process will be carried out by a West Coast company under a separate Navy contract. Somatogen will handle all phases of animal, pre-clinical and clinical trials and the final characterization of lipid encapsulated recombinant hemoglobin (rLEH). The Navy is coordinating the combined research efforts. Somatogen said the "primary goal" of the Navy contract is to "determine whether rLEH mimics additional characteristics of red blood cell hemoglobin." Preliminary studies conducted by the Navy have indicated that encapsulating the blood substitute may increase the product's half-life in the human circulatory system. A successful rLEH product would require no refrigeration, thus providing the military with a suitable blood substitute product for field use. Other potential applications, for the product, the company said, could include on-scene treatment of trauma, surgical blood replacement and certain types of anemia, such as chronic severe anemia associated with chemotherapy or AIDS. Independent of the Navy contract, Somatogen is developing its blood substitute product, which is based on genetically engineered free hemoglobin (rHgb). SGE-1.1 is slated to enter clinicals by early 1991. A pre-IND meeting with FDA has been scheduled for Nov. 5. Somatogen's product would compete with several companies that are developing hemoglobin-based blood substitutes. One barrier to successful development of these red blood-cell derived products has been evidence of renal and hepatic toxicities in limited clinical trials. To address the toxicity issue, FDA's Blood Products Advisory Committee met in a March 14 closed session that resulted in a draft consensus statement with recommendations for more preclinical and Phase I safety studies for red cell substitutes derived from hemoglobin ("The Pink Sheet" March 19, T&G-13). The FDA also has issued its own "points to consider" first draft on safety evaluation of hemoglobin-based oxygen carriers (see story below). Somatogen, which was one of about 10 companies to make presentations at the closed session, says it believes its recombinant product overcomes many of the potential problems. The firm sees advantages over the red blood-cell derived blood substitutes in the elimination of transmission of blood-borne infectious diseases; the elimination of need for typing and cross-matching; improved oxygen delivery with custom-delivery rate capabilities; longer shelf-life; and unlimited supply. Privately held Somatogen, founded in 1985 by President and CEO Charles Scoggin from the University of Colorado, has raised $21.8 mil. to date, most recently extending its capital pool with a$15.7 mil. private placement in late March 1990. The money from the offering is being used in part to fund a new pilot production facility, which is expected to be on-line by early 1991, and expanded research and administrative offices.

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