Table 1.

Clinical Trial NCT Number, Site, Principal Investigator(s), Phase of Trial, Cancer Type and Treatment Outcome Using DeltaRex-G as Monotherapy for Chemoresistant Solid Malignancies

Clinical Trial NCT No.	Clinical Site	Principal Investigator(s)	Phase	Cancer Type	No. of Patients	Treatment Outcome
NCT00121745 Dose level: minus 3–minus 111	Rochester, MN	E. Galanis	phase 1	pancreatic adenocarcinoma, gemcitabine resistant	12	RECIST v1.0: 1 SD, 11 PD 0% 1-year OS
NCT00504998a Dose level 1–3 (S.P.C., H. Bruckner, M.A. Morse, N. Assudani, F.L.H., E.M. Gordon, unpublished data)12, 13, 14	Santa Monica, CA	S.P. Chawla	phase 1/2	pancreatic adenocarcinoma, gemcitabine resistant	20	RECIST v1.0: 1CR, 2 PR, 12 SD 28.6% 1-year OS 21.4% 1.5-year OS 1 alive in sustained remission, 10 years N.B.: gained orphan drug and fast track designation for pancreatic adenocarcinoma from the FDA
	Manhattan, NY	H.W. Bruckner
	Durham, NC	M.A. Morse
NCT00505713a Dose level 1–410, 15, 16	Santa Monica, CA	S.P. Chawla	phase 1/2	bone and soft tissue sarcoma, chemotherapy resistant	36	38.5% 1-year OS; 31% 2-year OS 2 alive, with no active disease, 10 years; NB: gained orphan drug designation for soft tissue sarcoma from the FDA
NCT00505271a Dose level 1–4 (unpublished data)	Santa Monica, CA	S.P. Chawla	phase 1/2	breast cancer, chemotherapy resistant	20	60% 1-year OS 1 alive, 10 years
	Manhattan, NY	H.W. Bruckner
NCT00572130a Dose level 1–215	Santa Monica, CA	S.P. Chawla	phase 2	osteosarcoma, chemotherapy resistant	22	27.3% 1-year OS 22.7% 2-year OS 1 alive in sustained remission, 10 years; N.B.: gained orphan drug designation for osteosarcoma from the FDA

cfu, colony forming units; OS, overall survival; CR, complete remission; PR, partial response; SD, stable disease.

^aDose level 1, 1 × 10e11 cfu 2–3 times per week; dose level 2, 2 × 10e11 cfu 3 times per week; dose level 3, 3 × 10e11 cfu 3 times per week; dose level 4, 4 × 10e11 cfu 3 times per week.