In the control group, the average number of platelets before the treatment was 272.71 (176-525) × 109/L, while after the treatment it was 205.00 (85-357) × 109/L, representing a a drop of 67.71 × 109/L (p = 0.05). Drop in the number of platelets in the control group of patients
was statistically significant, while the number of platelets in the experimental group remained the same (Table 4). In the IP6 + Inositol group, the red bloood cell counts were 4.23 (3.56-5.22) × 1012/L and the hemoglobin level was 127.00 (110-151) g/L before treatment, while after the treatment the erythrocytes were 4.48 (4.08-4.78) × 1012/L and the hemoglobin level was 135.86 g L, representing an increase of 0.25 in the number of erythrocytes and 8.86 g/L in the hemoglobin level, although not significant. In the control group of patients the average number of erythrocytes before the treatment amounted to 4.45 × 1012/L, and find more 4.03 × 1012/L after the
treatment, while the hemoglobin level prior to treatment was 122.00 (103-142) g/L and 119.43 (106-135) g/L after treatment, which represented a decrease of 0.4 in the average number of erythrocytes and decrease of 2.57 in the hemoglobin level. Changes in red blood cell counts and in the hemoglobin levels are not statistically significant for either group. These relations are evident from the Table 4. There were no significant changes in AMN-107 in vitro tumor markers CEA and CA 15-3 during the treatment in both groups. For CEA, preoperative average value in the IP6 + Inositol group was 3.01 ng/mL (1.0-6.7), and postoperative value was 3.15 ng/mlL (1.5-6.9), which amounted to a nonsignificant average increase of 0.14 ng/mL (p = 0.39). In the control group of patients, preoperative average value for CEA was 2.40 ng/mL (1.2-5.3), while the postoperative average mafosfamide CEA value was 2.48 ng/mL, representing an average increase
of 0.08 ng/mL (p = 0.87) (Table 5). Preoperative average value of CA 15-3 in the IP6 + Inositol group was 13.05 U/mL (9.2-16.3), postoperative 13.80 U/mL (10.3-17.2), which was an increase of 0.75 U/mL (p = 0.08). In the control group, the average preoperative value for CA 15-3 was 26.27 U/mL ((12.7-49.6) and postoperative value was 27.41 U/ml (11.9-62), representing an increase of 1.14 U/mL (p = 0.86) (Table 5). Table 5 Values of Tumor Markers CEA and CA15-3 Tumor Markers Placebo Group (Mean ± SD) IP6 + Inositol Group (Mean ± SD) CEA (ng/mL) Before Treatment 2.40 ± 1.53 3.01 ± 1.80 After Treatment 2.48 ± 1.27 3.15 ± 1.85 p value 0.87 0.39 CA 15-3 (kU/L) Before Treatment 26.27 ± 15.20 13.05 ± 2.35 After Treatment 27.41 ± 17.28 13.80 ± 2.67 p value 0.86 0.08 Other laboratory parameters that were monitored during the treatment (LDH, AST, ALT, AP, bilirubin, urea, creatinine, and electrolytes) were stable in both groups of patients and there were no deviations from the ICG-001 clinical trial reference value.