A Phase 1 Safety Study of SANGUINATE™ In Patients With Acute Severe Anemia.

Data collection for each patient during the in-patient portion of the study will be required for up to a maximum of 14 days while under critical care, with additional collection of safety-related findings at 7 days and 14 days after the last infusion of SANGUINATE. Each patient will thus have up to 28 days participation in the trial.

A minimum of 100 subjects are to be enrolled and to receive at least one infusion of SANGUINATE, with 14-day follow-up after the last infusion.

Because of the life-threatening effects of severe anemia, it is expected that all patients in this trial will receive care within a critical care facility (may be called intensive care or some similar name), wherein all patients will have real-time monitoring of vital signs and ECG (e.g., by telemetry) before, during, and after all study drug infusions.

Inclusion criteria

• The patient would otherwise receive RBC transfusion for treatment of severe anemia but cannot (hemolytic/allosensitized or no compatible blood) or will not (religious/personal objection) receive RBCs
• Hemoglobin ≤ 5 g/dL, or hemoglobin ≤ 7 g/dL following a decline of ≥ 5 g/dL over less than 7 days
• Age ≥ 18 years
• Receiving or willing to receive supplemental iron therapy (unless contraindicated)
• Receiving or willing to receive erythropoiesis-stimulating agent (EPO) therapy
• Patient or legally authorized representative provided consent to participate
• Investigator determination that the patient is an appropriate candidate for study enrollment

Exclusion criteria

• Hemoglobin ≤ 2 g/dL
• Presence of severe trauma (e.g., Injury Severity Score (ISS)/New Injury Severity Score (NISS) Score ≥ 25)
• Unable to provide sufficient blood sample volume for screening assessments; or
• Pregnant; or
• Investigator determination that the patient is not an appropriate candidate for study enrollment