C. NOVYI FOR THE TREATMENT OF SOLID TUMORS IN HUMANS
The present invention provides, inter alia, methods for treating or ameliorating an effect of a solid tumor present in a human. These methods include administering intratumorally to the human a unit dose of C. novyi , preferably C. novyi NT, colony forming units (CFUs), which contains about 1×10 3 -1×10 7 CFUs suspended in a pharmaceutically acceptable carrier or solution. Methods for debulking a solid tumor present in a human, methods for ablating a solid tumor present in a human, a method for microscopically precise excision of tumor cells in a human, methods for treating or ameliorating an effect of a solid tumor that has metastasized to one or more sites in a human, unit doses of C. novyi , preferably C. novyi NT, CFUs, and kits for treating or ameliorating an effect of a solid tumor present in a human are also provided.
1 . A unit dose of C. novyi colony forming units (CFUs) for debulking or abalating a solid tumor present in a human, comprising about 1×10 3 -1×10 6 CFUs in a pharmaceutically acceptable carrier or solution.
2 . The unit dose of claim 1 , wherein the solid tumor is selected from the group consisting of soft tissue sarcoma, hepatocellular carcinoma, breast cancer, pancreatic cancer, and melanoma.
3 . The unit dose of claim 1 , wherein the solid tumor is leiomyosarcoma.
4 . The unit dose of claim 3 , wherein the solid tumor is retroperitoneal leiomyosarcoma.
5 . The unit dose of claim 1 , wherein the C. novyi CFUs are selected from the group consisting of vegetative and spore forms.
6 . The unit dose of claim 1 , wherein the C. novyi is C. novyi NT.
7 . The unit dose of claim 6 , wherein the unit dose comprises about 1×10 4 C. novyi NT spores in a pharmaceutically acceptable carrier or solution.
8 . The unit dose of claim 1 , wherein the unit dose is formulated for intratumoral administration.
9 . The unit dose of claim 1 , wherein the unit dose is effective to debulk or ablate the solid tumor without administration of additional anti-cancer agents.
10 . The unit dose of claim 1 , wherein the unit dose is effective to debulk or ablate the solid tumor by a single treatment.
11 . A unit dose of C. novyi colony forming units (CFUs) for microscopically precise excision of tumor cells in a human, comprising about 1×10 3 -1×10 6 CFUs in a pharmaceutically acceptable carrier or solution.
12 . The unit dose of claim 11 , wherein the unit dose is effective for microscopically precise excision of tumor cells without administration of additional anti-cancer agents.
13 . A kit for debulking or abalating a solid tumor present in a human, comprising a unit dose according to claim 1 and instructions for use of the kit.
14 . The kit of claim 13 , further comprising one or more antibiotics, which are effective to treat or alleviate an adverse side effect caused by the C. novyi CFUs.
15 . The kit of claim 13 , wherein the C. novyi CFUs are selected from the group consisting of vegetative and spore forms.
16 . The kit of claim 13 , wherein the C. novyi is C. novyi NT.
17 . The kit of claim 16 , wherein the unit dose comprises about 1×10 4 C. novyi NT spores in a pharmaceutically acceptable carrier or solution.
18 . The kit of 13 , further comprising 1-4 unit doses of the C. novyi CFUs for carrying out 1-4 treatment cycles.
19 . The kit of claim 17 , further comprising 1-4 unit doses of the C. novyi NT spores for carrying out 1-4 treatment cycles.