Do not make unauthorized copies. Figure 4 . Low Dose Vigil Phase I Ewing’s Patients: ELISPOT response status. Gray lines indicates time points off treatment. Eighty patients in total (54 females, aged 13-84 / 26 males, aged 12-76) entered into Phase I trial involving 19 solid tumor cancers. Four hundred sixty-four (464) Vigil injections were administered and no ≥ Grade 3 toxic events attributed to Vigil have been observed. Dose administered ranged from 1 x 10 6 cells/injection to 2.5 x 107 cells/injection via intradermal injection once a month for a minimum of 4 months. The prolonged survival shown in Figure 5 involving predominantly advanced stage, heavily pretreated patients is greater than historical expectation (Senzer, Barve et al. 2013) . Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 25 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document.