SILVESTROL, SILVESTROL ANALOGS AND USES THEREOF

• US 20140255432A1
• Filed: 07/27/2012
• Published: 09/11/2014
• Est. Priority Date: 07/27/2011
• Status: Abandoned Application

• Current Assignee: Ohio State Innovation Foundation (Ohio State University)
• Original Assignee: Ohio State Innovation Foundation (Ohio State University)
• Inventors: Baiocchi, Robert A., Lucas, David M., Patton, John Thomas Jr., Kinghorn, Douglas, Grever, Michael
• Application Number:
  US14/235,371
• Publication Number:
  US 20140255432A1
• Time in Patent Office: Days
• US Class Current: 424/174.1
• CPC Class Codes: A61K 2039/55511 Organic adjuvants
• CPC Class Codes: A61K 2239/31 characterized by the route of administration
• CPC Class Codes: A61K 2239/38 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/35 having six-membered rings with one oxygen as the only ring hetero atom
• CPC Class Codes: A61K 31/357 having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
• CPC Class Codes: A61K 39/39 characterised by the immunostimulating additives, e.g. chemical adjuvants
• CPC Class Codes: A61K 39/461 characterised by the cell type used
• CPC Class Codes: A61K 39/464838 Viral antigens
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Disclosed herein are treatment methods, vaccination methods, compositions, co-therapeutic methods, combination therapeutic compositions and kits comprising silvestrol and silvestrol analogs alone or in combination with therapeutic and preventative therapies. Disclosed herein are also methods, compositions and kits that can be used to treat cancer, viral infections, to modulate the immune system or as preventative therapies.

Claims

1-42. -42. (canceled)

43. A composition comprising:

silvestrol or a silvestrol analog;

a anti-cancer agent; and

a pharmaceutically acceptable carrier.

44. The composition of claim 43, wherein the silvestrol or silvestrol analog is silvestrol.

45. The composition of claim 43, wherein the silvestrol or silvestrol analog is a silvestrol analog.

46. The composition of claim 45, wherein the silvestrol analog is a compound of Formula (I) or a salt or prodrug thereof or a compound (including stereoisomers within the dioxanyl group) of formula (i) or a salt or prodrug thereof.

47. The composition of claim 43, wherein the anti-cancer agent is an antibody, a preventive vaccine, a therapeutic vaccine, a cytokine, a biologic fusion construct, a nucleic acid constructs (i.e.:

DNA-based vaccines or immune modulatory products), a receptor ligand, a cytokine or receptor antagonist, or an adoptively transferred cell (NK, T cells, DCs).

48. The composition of claim 43, wherein the composition further comprises one or more immunomodulatory agents.

49. The composition of claim 48, wherein the one or more immunomodulatory agents is a cytokine, immune system adjuvant, fusion protein, an antibody, a preventive vaccine, a therapeutic vaccine, a cytokine, a biologic fusion construct, a nucleic acid constructs (i.e.:

DNA-based vaccines or immune modulatory products), a receptor ligand, a cytokine or receptor antagonist, or an adoptively transferred cell (NK, T cells, DCs).

50. A method comprising the step of administering a composition comprising silvestrol or a silvestrol analog, and a pharmaceutically acceptable carrier, wherein the composition is administered in a dosage and frequency less than 0.5 mg/kg/day.

51. The method of claim 50, where in the subject has been diagnosed with a cancer prior to administration.

52. The method of claim 50, wherein the silvestrol or silvestrol analog is silvestrol.

53. The method of claim 50, wherein the silvestrol or silvestrol analog is a silvestrol analog.

54. The method of claim 50, wherein the silvestrol analog is a compound of Formula (I) or a salt or prodrug thereof or a compound (including stereoisomers within the dioxanyl group) of formula (i) or a salt or prodrug thereof.

55. The method of claim 50, wherein the composition further comprises one or more immunomodulatory agents.

56. The method of claim 55, wherein the one or more immunomodulatory agents is a cytokine, immune system adjuvant, fusion protein, an antibody, a preventive vaccine, a therapeutic vaccine, a cytokine, a biologic fusion construct, a nucleic acid constructs (i.e.:

DNA-based vaccines or immune modulatory products), a receptor ligand, a cytokine or receptor antagonist, or an adoptively transferred cell (NK, T cells, DCs).

57. The method of claim 55, wherein one or more immunomodulatory agents potentiates an antibody-dependent cell-mediated cytoxicity (“

ADCC”

) response in the subject.

58-128. -128. (canceled)