Table 1.

Clinical studies using RBC prepared with the S-303 treatment process

S-303 treatment processa	Phase	Number of subjects enrolled	Number of subjects receiving S-303 RBCs	Primary endpoint	Reference
First generation	1A	43	21	24 h recovery: 78.9% (test) and 83.9% (control)	33
First generation	1B	28	28	24 h recovery: 81.1% (test)	33
First generation	1C	part A 29 part B 11	40	part A: 24 h recovery: 81.7% (test) and 84.5% (control) part B: tolerability of full-unit transfusion	33
First generation	3	148/200c	74	incidence of myocardial infarction, renal failure, death: 21.6% (test) and 20.5% (control)	34
First generation	3	26/50c	17	mean Hb transfused (g Hb/kg/day): 1.3 (test) and 0.9 (control)	35
Interim modified	1	28	28	24 h recovery: 79.8% (test) and 84.5% (control)	36
Second generation	1	27	26	24 h recovery: 88.0% (test) and 90.1% (control)	37

^aThe first-generation process used 0.2 mmol/l S-303 and 2 mmol/l GSH, a compound adsorption device (CAD) and Esol as the additive solution. An interim modified process was a precursor to the second generation process during optimization to reduce the potential for immune response. The modified process used 0.2 mmol/l S-303 and 20 mmol/l GSH (monosodium salt plus one equivalent of NaOH to pH9) and AS-3 (Nutricel) as the additive solution. The second-generation process used 0.2 mmol/l S-303 and 20 mmol/l GSH (monosodium salt, pH 7), a diluent solution and AS-5 (Optisol) as the additive solution.

^cThe phase III clinical trials were halted prematurely. The studies had planned to enroll 200 cardiovascular (CV) surgery patients and 50 chronically transfused patients however the CV surgery patient study had sufficient power to demonstrate noninferiority.