Table 2.

Mean ± SEM whole blood concentrations of rhTNF (ng/mL) following infusion with various dose levels of CYT-6091

Time, minDose administered, μg/m2
50100150200250300400500600
5 7.7 ± 0.117.2 ± 2.625.2 ± 1.347.6 ± 5.858.2 ± 16.462.6 ± 12.185.1 ± 11.9106.7 ± 9.7154.7 ± 34.7
15 5.2 ± 0.710.1 ± 1.516.5 ± 1.034.2 ± 5.643.8 ± 9.748.1 ± 13.674.9 ± 13.473.8 ± 15.8147.5 ± 22.8
30 4.0 ± 0.66.8 ± 1.011.4 ± 1.925.9 ± 6.924.4 ± 4.833.3 ± 9.858.4 ± 12.260.0 ± 16.2109.2 ± 16.1
60 2.5 ± 0.43.5 ± 0.36.5 ± 1.215.5 ± 4.721.7 ± 2.821.3 ± 6.746.5 ± 4.643.3 ± 13.390.2 ± 12.7
120 1.3 ± 0.31.7 ± 0.13.2 ± 0.78.4 ± 2.910.9 ± 1.510.9 ± 4.021.7 ± 4.524.6 ± 8.347.2 ± 3.4
180 0.9 ± 0.21.1 ± 0.11.8 ± 0.44.6 ± 1.34.7 ± 0.64.3 ± 1.411.8 ± 3.812.2 ± 3.824.0 ± 1.8
240 0.6 ± 0.10.7 ± 0.11.3 ± 0.33.1 ± 0.92.6 ± 0.42.4 ± 0.86.1 ± 1.68.9 ± 3.012.3 ± 1.1
480 0.2 ± 0.10.2 ± 0.00.4 ± 0.21.0 ± 0.20.8 ± 0.00.8 ± 0.41.6 ± 0.52.6 ± 0.62.6 ± 0.0
1,440 BDLBDLBDLBDLBDLBDL0.3 ± 0.11.2 ± 0.10.6 ± 0.0
Analysis (mean ± SD) of the pharmacokinetic parameters of CYT-6091 in man  
Dose of CYT-6091, μg/m2 Total dose, μg C max, ng/mL Terminal half-life, min AUC, min × ng/mL Volume of distribution, mL Clearance, mL/min
50 90 ± 57.7 ± 0.2120.7 ± 19.6611 ± 19218,686 ± 2,988155 ± 40
100 202 ± 3317.2 ± 4.6131.3 ± 21.0977 ± 6424,064 ± 8,308209 ± 48
150 270 ± 4925.2 ± 2.3127.0 ± 34.41,575 ± 41218,641 ± 2,845177 ± 67
200 314 ± 747.7 ± 9.9146.3 ± 22.23,789 ± 1,46512,063 ± 5,17490 ± 28
250 410 ± 6258.2 ± 16.4112.7 ± 27.23,888 ± 89011,355 ± 3,536107 ± 23
300 563 ± 4562.6 ± 21.0113.0 ± 46.24,403 ± 2,22313,241 ± 4,637159 ± 96
400 785 ± 14885.1 ± 20.7266.0 ± 79.09,297 ± 3,84516,265 ± 9,02197 ± 51
500 823 ± 153106.7 ± 16.7371.1 ± 13311,206 ± 4,35931,248 ± 27,13784 ± 53
600 1,208 ± 214154.7 ± 34.7160.5 ± 52.017,730 ± 2,92810,865 ± 5,66671 ± 24

Abbreviation: BDL, below the limit of detection.