Page 35 of Attachment H 
TABLE 2 
L- AS PARAG INAS E - CLINICAL TOXICITY 
Oettgen, H. F. et ai., Cancer , 25:253 (1970) 
Sloan-Kettering Experience 1967-69 
Enzyme Source: Worthington 19 Lots 
Squibb 16 
Bayer 18 
Merck 6 
Dosage: 200, 1000, 5000 I.U.Ag I.V. 
35 I.U./mg 
Y 
360 I.U./mg 
Duration: 4 weeks 
Patients: 274 (131 children, 143 adults) 
Batches accepted for use if pyrogen assay m rabbits showed 
mean, temperature rise of *1.5°C in 3 rabbits. Temperatures 
of this magnitude induced by endotoxin doses 2-3 orders of 
magnitude below lethal doses. Good correlation between 
pyrogenicity in rabbits and febrile reactions in patients. 
[ 471 ] 
