• Biopure (Cambridge, Massachusetts) reported that the U.S. Naval Medical Research Center (NMRC) has submitted to the FDA an investigational new drug application to conduct a two-stage clinical trial of the company’s oxygen therapeutic Hemopure [hemoglobin glutamer -250 (bovine)] for the out-of-hospital treatment of trauma patients. Under a research agreement with Biopure, the NMRC has primary responsibility for designing, seeking FDA acceptance of and directing the trial, Restore Effective Survival in Shock (RESUS). The objective of the single-blinded, multicenter, randomized, controlled, Phase IIb/III study is to assess the safety and efficacy of Hemopure, as compared to standard treatment, in reducing morbidity and mortality in severely injured patients experiencing hemorrhagic shock in the out-of-hospital setting, where blood is not available for transfusion. Patients would be randomized to receive either Hemopure or standard therapy at the scene of the injury and during transport to the hospital.
• GeneGo (St. Joseph, Michigan), a provider of databases, software and services in systems biology, said that it has received a Phase I SBIR grant from the National Institute of General Medical Science for development of methodologies intended for reconstruction of functional networks affected in common human diseases. In Phase I, GeneGo will generate and test novel algorithms enabling comparison of disease related OMICs datasets of different origin, based on networks topology and content. The company will test its approach on disease datasets in collaboration with the Van Andel Research Institute (Grand Rapids, Michigan).