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- Nachgewiesen in: USPTO Patent Grants
- Sprachen: English
- Patent Number: 10617,723
- Publication Date: April 14, 2020
- Appl. No: 14/781273
- Application Filed: March 28, 2014
- Assignees: BIOMED VALLEY DISCOVERIES, INC. (Kansas City, MO, US), THE JOHNS HOPKINS UNIVERSITY (Baltimore, MD, US)
- Claim: 1. A method for debulking or ablating a solid tumor present in a human comprising administering intratumorally to the human a unit dose of C. novyi colony forming units (CFUs) comprising 1×10 3 -1×10 5 CFUs suspended in a pharmaceutically acceptable carrier or solution, wherein the C. novyi is effective to debulk or ablate the solid tumor without administration of additional anti-cancer agents.
- Claim: 2. The method according to claim 1 , wherein the solid tumor is selected from the group consisting of soft tissue sarcoma, hepatocellular carcinoma, breast cancer, pancreatic cancer, and melanoma.
- Claim: 3. The method according to claim 1 , wherein the solid tumor is leiomyosarcoma.
- Claim: 4. The method according to claim 3 , wherein the solid tumor is retroperitoneal leiomyosarcoma.
- Claim: 5. The method according to claim 1 , wherein the unit dose comprises about 1×10 3 -1×10 4 C. novyi CFUs.
- Claim: 6. The method according to claim 1 , wherein the C. novyi CFUs are selected from the group consisting of vegetative and spore forms.
- Claim: 7. The method according to claim 1 , wherein the C. novyi is C. novyi NT.
- Claim: 8. The method according to claim 7 , wherein the unit dose comprises 1×10 3 -1×10 5 C. novyi NT spores.
- Claim: 9. The method according to claim 7 , wherein the unit dose comprises about 1×10 3 -1×10 4 C. novyi NT spores.
- Claim: 10. The method according to claim 1 , wherein the administering step comprises injecting the unit dose at a single location into the tumor.
- Claim: 11. The method according to claim 1 , wherein the administering step comprises injecting the unit dose at multiple unique locations into the tumor.
- Claim: 12. The method according to claim 1 , wherein the administering step comprises injecting the unit dose at 1-5 unique locations into the tumor.
- Claim: 13. The method according to claim 1 , wherein the administering step comprises injecting the unit dose at 5 or more unique locations into the tumor.
- Claim: 14. The method according to claim 1 further comprising administering a plurality of treatment cycles to the human, each treatment cycle comprising injecting one unit dose of the C. novyi CFUs into the solid tumor.
- Claim: 15. The method according to claim 14 , wherein 2-10 treatment cycles are administered.
- Claim: 16. The method according to claim 14 , wherein 2-4 treatment cycles are administered.
- Claim: 17. The method according to claim 14 , wherein an interval between each treatment cycle is about 5-100 days.
- Claim: 18. The method according to claim 14 , wherein an interval between each treatment cycle is about 7 days.
- Claim: 19. The method according to claim 8 further comprising administering IV fluids to the human before, during, and/or after each administration of the C. novyi NT spores.
- Claim: 20. The method according to claim 8 further comprising administering a plurality of treatment cycles to the human, each treatment cycle comprising injecting one unit dose of the C. novyi NT spores into the solid tumor.
- Claim: 21. The method according to claim 20 , wherein 2-4 treatment cycles are administered.
- Claim: 22. The method according to claim 1 further comprising administering IV fluids to the human before, during, and/or after each administration of the C. novyi.
- Claim: 23. The method according to claim 1 further comprising providing the human with a first course of antibiotics for a period of time and at a dosage that is effective to treat or alleviate an adverse side effect selected from the group consisting of infections, vomiting, hematochezia, fever, and combinations thereof caused by the C. novyi.
- Claim: 24. The method according to claim 23 , wherein the antibiotics are administered for two weeks post C. novyi administration.
- Claim: 25. The method according to claim 23 , wherein the antibiotics are selected from the group consisting of amoxicillin, clavulanate, metronidazole, and combinations thereof.
- Claim: 26. The method according to claim 23 further comprising providing the human with a second course of antibiotics for a period of time and at a dosage that is effective to treat or alleviate an adverse side effect selected from the group consisting of infections, vomiting, hematochezia, fever, and combinations thereof caused by the C. novyi.
- Claim: 27. The method according to claim 26 , wherein the second course of antibiotics is initiated after completion of the first course of antibiotics and is carried out for 1-6 months.
- Claim: 28. The method according to claim 26 , wherein the second course of antibiotics is initiated after completion of the first course of antibiotics and is carried out for 3 months.
- Claim: 29. The method according to claim 26 , wherein the antibiotic used in the second course is doxycycline.
- Claim: 30. The method according to claim 1 , further comprising administering to the human an anti-cancer agent selected from the group consisting of chemotherapy, radiation therapy, immunotherapy, and combinations thereof, after the C. novyi have acted to debulk or ablate the solid tumor.
- Claim: 31. The method according to claim 30 , wherein the immunotherapy comprises administering to the human an immune checkpoint inhibitor.
- Claim: 32. The method according to claim 1 , wherein the solid tumor is resistant to a therapy selected from the group consisting of chemotherapy, radiation therapy, immunotherapy, and combinations thereof.
- Claim: 33. The method according to claim 30 , wherein the chemotherapy comprises administering to the human an agent selected from the group consisting of an anti-metabolite, a microtubule inhibitor, a DNA damaging agent, an antibiotic, an anti-angiogenesis agent, a vascular disrupting agent, a molecularly targeted agent, and combinations thereof.
- Claim: 34. The method according to claim 30 , wherein the chemotherapy comprises administering to the human an agent selected from the group consisting of gemcitabine, taxol, adriamycin, ifosfamide, trabectedin, pazopanib, abraxane, avastin, everolimus, and combinations thereof.
- Claim: 35. The method according to claim 1 , wherein the solid tumor is refractory to standard therapy or the solid tumor is without an available standard therapy.
- Claim: 36. The method according to claim 1 , wherein the unit dose of C. novyi induces a potent localized inflammatory response and an adaptive immune response in the human.
- Claim: 37. A method for microscopically precise excision of tumor cells in a human comprising administering intratumorally to the human a unit dose of C. novyi NT colony forming units (CFUs) comprising 1×10 3 -1×10 5 CFUs suspended in a pharmaceutically acceptable carrier or solution, wherein the C. novyi is effective for microscopically precise excision of the tumor cells without administration of additional anti-cancer agents.
- Claim: 38. A method for debulking or ablating a solid tumor that has metastasized to one or more sites in a human comprising administering intratumorally to the human a unit dose of C. novyi NT colony forming units (CFUs) comprising 1×10 3 -1×10 5 CFUs suspended in a pharmaceutically acceptable carrier or solution, wherein the C. novyi is effective to debulk or ablate the solid tumor without administration of additional anti-cancer agents.
- Claim: 39. The method according to claim 38 , wherein at least one site is distal to the original solid tumor.
- Claim: 40. A method for debulking a solid tumor present in a human comprising administering intratumorally to the human a unit dose of C. novyi CFUs comprising 1×10 3 -1×10 5 CFUs suspended in a pharmaceutically acceptable carrier or solution, wherein the C. novyi is effective to debulk the solid tumor without administration of additional anti-cancer agents.
- Claim: 41. The method according to claim 40 , wherein the solid tumor is selected from the group consisting of soft tissue sarcoma, hepatocellular carcinoma, breast cancer, pancreatic cancer, and melanoma.
- Claim: 42. A method for debulking a solid tumor present in a human comprising administering intratumorally to the human one to four cycles of a unit dose of C. novyi NT spores comprising 1×10 3 -1×10 5 spores per cycle, each unit dose of C. novyi NT being suspended in a pharmaceutically acceptable carrier or solution, wherein the C. novyi is effective to debulk the solid tumor without administration of additional anti-cancer agents.
- Claim: 43. A method for debulking or ablating a solid tumor present in a human comprising administering intratumorally to the human one to four cycles of a unit dose of C. novyi NT spores comprising 1×10 3 -1×10 5 spores per cycle, each unit dose of C. novyi NT spores being suspended in a pharmaceutically acceptable carrier or solution, wherein the C. novyi is effective to debulk or ablate the solid tumor without administration of additional anti-cancer agents.
- Claim: 44. A method for ablating a solid tumor present in a human comprising administering intratumorally to the human a unit dose of C. novyi CFUs comprising 1×10 3 -1×10 4 CFUs suspended in a pharmaceutically acceptable carrier or solution, wherein the C. novyi is effective to ablate the solid tumor without administration of additional anti-cancer agents leaving a margin of normal tissue.
- Claim: 45. The method according to claim 44 , wherein the tumor is a sarcoma.
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- Primary Examiner: Tichy, Jennifer M. H.
- Attorney, Agent or Firm: Bryan Cave Leighton Paisner LLP
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