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. Author manuscript; available in PMC: 2011 Dec 15.
Published in final edited form as: Clin Cancer Res. 2010 Sep 27;16(24):6139–6149. doi: 10.1158/1078-0432.CCR-10-0978

Table 2.

Mean ± SEM Whole Blood Concentrations of rhTNF (ng/ml) Following Infusion with Various Dose Levels of CYT-6091

Time (min) Dose Administered (μg/m2)
50 100 150 200 250 300 400 500 600
5
7.7 ± 0.1 17.2 ± 2.6 25.2 ± 1.3 47.6 ± 5.8 58.2 ± 16.4 62.6 ± 12.1 85.1 ± 11.9 106.7 ± 9.7 154.7 ± 34.7
15
5.2 ± 0.7 10.1 ± 1.5 16.5 ± 1.0 34.2 ± 5.6 43.8 ± 9.7 48.1 ± 13.6 74.9 ± 13.4 73.8 ± 15.8 147.5 ± 22.8
30
4.0 ± 0.6 6.8 ± 1.0 11.4 ± 1.9 25.9 ± 6.9 24.4 ± 4.8 33.3 ± 9.8 58.4 ± 12.2 60.0 ± 16.2 109.2 ± 16.1
60
2.5 ± 0.4 3.5 ± 0.3 6.5 ± 1.2 15.5 ± 4.7 21.7 ± 2.8 21.3 ± 6.7 46.5 ± 4.6 43.3 ± 13.3 90.2 ± 12.7
120
1.3 ± 0.3 1.7 ± 0.1 3.2 ± 0.7 8.4 ± 2.9 10.9 ± 1.5 10.9 ± 4.0 21.7 ± 4.5 24.6 ± 8.3 47.2 ± 3.4
180
0.9 ± 0.2 1.1 ± 0.1 1.8 ± 0.4 4.6 ± 1.3 4.7 ± 0.6 4.3 ± 1.4 11.8 ± 3.8 12.2 ± 3.8 24.0 ± 1.8
240
0.6 ± 0.1 0.7 ± 0.1 1.3 ± 0.3 3.1 ± 0.9 2.6 ± 0.4 2.4 ± 0.8 6.1 ± 1.6 8.9 ± 3.0 12.3 ± 1.1
480
0.2 ± 0.1 0.2 ± 0.0 0.4 ± 0.2 1.0 ± 0.2 0.8 ± 0.0 0.8 ± 0.4 1.6 ± 0.5 2.6 ± 0.6 2.6 ± 0.0
1440 BDL BDL BDL BDL BDL BDL 0.3 ± 0.1 1.2 ± 0.1 0.6 ± 0.0
BDL= Below the limit of detection.

Analysis (Mean ± S.D.) of the Pharmacokinetic Parameters of CYT-6091 in Man

Dose of CYT-6091 (μg/m2) Total Dose (μg) Cmax (ng/mL) Terminal Half Life (min) AUC (min*ng/mL) Volume of Distribution (mL) Clearance (mL/min)

50
90 ± 5 7.7 ± 0.2 120.7 ± 19.6 611 ± 192 18686 ± 2988 155 ± 40
100
202 ± 33 17.2 ± 4.6 131.3 ± 21.0 977 ± 64 24064 ± 8308 209 ± 48
150
270 ± 49 25.2 ± 2.3 127.0 ± 34.4 1575 ± 412 18641 ± 2845 177 ± 67
200
314 ± 7 47.7 ± 9.9 146.3 ± 22.2 3789 ± 1465 12063 ± 5174 90 ± 28
250
410 ± 62 58.2 ± 16.4 112.7 ± 27.2 3888 ± 890 11355 ± 3536 107 ± 23
300
563 ± 45 62.6 ± 21.0 113.0 ± 46.2 4403 ± 2223 13241 ± 4637 159 ± 96
400
785 ± 148 85.1 ± 20.7 266.0 ± 79.0 9297 ± 3845 16265 ± 9021 97 ± 51
500
823 ± 153 106.7 ± 16.7 371.1 ± 133 11206 ± 4359 31248 ± 27137 84 ± 53
600 1208 ± 214 154.7 ± 34.7 160.5 ± 52.0 17730 ± 2928 10865 ± 5666 71 ± 24