Methods and compositions for delivery of catecholic butanes for treatment of diseases
AssigneeErimos Pharmaceuticals LLC
InventorsJonathan Heller, Neil Frazer, Amy Tsui Collins
Life of this patent
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Abstract
The present invention provides kits, methods and compositions for the treatment of diseases, such as, for example, non-cancer proliferative diseases, neurodegenerative diseases, diabetes and hypertension. The compositions herein contain a substantially pure preparation of at least one catecholic butane, including, for example, NDGA Compounds in a pharmaceutically acceptable carrier or excipient by various routes of administration.
Claims95
A pharmaceutical composition for treatment of a disease in a subject comprising at least one catecholic butane other than NDGA, and a pharmaceutically acceptable carrier or excipient, wherein the composition is formulated for delivery by a route other than by direct injection into or topical application onto an affected tissue, and wherein the disease is other than a malignant, pre-malignant or benign tumor and other than HIV, HPV or HSV infection and other than diabetes or psoriasis.
The pharmaceutical composition of claim 12, wherein the host transcription factor is Sp1.
The pharmaceutical composition of claim 12, wherein the disease results from or is associated with an infection selected from the group consisting of HBV infection, EBV infection, HTLV infection, JC virus infection, Varicella-zoster virus infection, adenovirus infection and parvovirus infection.
A pharmaceutical composition for treatment of diabetes in a subject comprising at least one catecholic butane, and a pharmaceutically acceptable carrier or excipient, wherein the composition is formulated for delivery by a route other than by direct injection into or topical application onto an affected tissue, wherein the catecholic butane has the formula:
- wherein both of R1 and R2 are —OCH3 and both of R3 and R4 are —OCH3;
- or R1 and R2 are independently —OCH3 or an unsubstituted or substituted amino acid residue, and R3 and R4 are independently —OCH3 or an unsubstituted or substituted amino acid residue, with the proviso that at least one of R1, R2, R3 and R4 is an unsubstituted or substituted amino acid residue;
- and
- wherein R5, and R6 independently are —H or an alkyl;
- or a salt thereof.
A pharmaceutical composition for treatment of psoriasis in a subject comprising tetra-dimethylglycinyl NDGA, and a pharmaceutically acceptable carrier or excipient, wherein the composition is formulated for delivery by a route other than by direct injection into or topical application onto an affected tissue.
A method of treatment of a disease in a subject comprising the steps of
- (a) providing a composition comprising at least one catecholic butane other than NDGA, and a pharmaceutically acceptable carrier;
- and
- (b) administering the composition to the subject by a route other than by direct injection into or topical application onto an affected tissue;
- wherein the disease is other than a tumor, diabetes or psoriasis, and other than HIV, HPV or HSV infection.
A method of treatment of diabetes in a subject comprising the steps of
- (a) providing a composition comprising at least one catecholic butane, and a pharmaceutically acceptable carrier;
- and
- (b) administering the composition to the subject;
- wherein the catecholic butane has the formula:
- wherein both of R1 and R2 are —OCH3 and both of R3 and R4 are —OCH3;
- or R1 and R2 are independently —OCH3 or an unsubstituted or substituted amino acid residue, and R3 and R4 are independently —OCH3 or an unsubstituted or substituted amino acid residue, with the proviso that at least one of R1, R2, R3 and R4 is an unsubstituted or substituted amino acid residue;
- and
- wherein R5, and R6 independently are —H or an alkyl;
- or a salt thereof.
A method of treatment of psoriasis in a subject comprising the steps of
- (a) providing a composition comprising a substantially pure preparation of tetra-dimethylglycinyl NDGA, and a pharmaceutically acceptable carrier or excipient;
- and
- (b) applying the composition to the subject.
A method of reducing serum triglyceride in a subject comprising the steps of:
- (a) providing a composition that comprises a substantially pure preparation of at least one NDGA derivative;
- and
- (b) administering an effective amount of the composition to the subject, whereby the serum triglyceride level in the subject is reduced, wherein the NDGA derivative has a formula:
- wherein R1, R2, R3 and R4 independently represent —OH, a lower alkoxy, a lower acyloxy, or an unsubstituted or substituted amino acid residue or salt thereof, but are not each —OH simultaneously;
- and R5, and R6 independently represent —H or an alkyl.
A method of reducing serum glucose in a subject comprising the steps of
- (a) providing a composition that comprises a substantially pure preparation of at least one NDGA derivative;
- and
- (b) administering an effective amount of the composition to the subject whereby serum glucose level in the subject is reduced, wherein the NDGA derivative has a formula:
- wherein both of R1 and R2 are —OCH3 and both of R3 and R4 are —OCH3;
- or R1 and R2 are independently —OCH3 or an unsubstituted or substituted amino acid residue, and R3 and R4 are independently —OCH3 or an unsubstituted or substituted amino acid residue, with the proviso that at least one of R1, R2, R3 and R4 is an unsubstituted or substituted amino acid residue;
- and
- wherein R5, and R6 independently are —H or an alkyl;
- or a salt thereof.
A method of reducing serum non-esterified fatty acid in a subject comprising the steps of
- (a) providing a composition that comprises a substantially pure preparation of at least one NDGA derivative;
- and
- (b) administering an effective amount of the NDGA derivative to the subject whereby serum non-esterified fatty acids in the subject are reduced, wherein the NDGA derivative has a formula:
- wherein R1, R2, R3 and R4 independently represent —OH, a lower alkoxy, a lower acyloxy, or an unsubstituted or substituted amino acid residue or salt thereof, but are not each —OH simultaneously;
- and R5, R6 independently represent —H or an alkyl.
A method of reducing low density lipoprotein cholesterol (LDL-C) in a subject comprising the steps of
- (a) providing a composition that comprises a substantially pure preparation of at least one NDGA derivative;
- and
- (b) administering an effective amount of the composition to the subject LDL-C level in the subject is reduced, wherein the NDGA derivative has a formula:
- wherein R1, R2, R3 and R4 independently represent —OH, a lower alkoxy, a lower acyloxy, or an unsubstituted or substituted amino acid residue or salt thereof, but are not each —OH simultaneously;
- and R5, R6 independently represent —H or an alkyl.
A method of treatment of hypertension in a subject comprising the steps of
- (a) providing a composition that comprises a substantially pure preparation of at least one NDGA derivative, and
- (b) administering an effective amount of the composition to the subject, whereby hypertension in the subject is reduced, such as vascular systolic and diastolic systemic and pulmonary hypertension, wherein the NDGA derivative has a formula:
- wherein R1, R2, R3 and R4 independently represent —OH, a lower alkoxy, a lower acyloxy, or an unsubstituted or substituted amino acid residue or salt thereof, but are not each —OH simultaneously;
- and R5, R6 independently represent —H or an alkyl;
- provided further that the NDGA derivative is not 3-O-methyl NDGA.
A method of treatment of Alzheimer's disease in a subject in need of treatment comprising the steps of:
- (a) providing a composition that comprises at least one NDGA derivative having the formula:
- wherein R1, R2, R3 and R4 independently represent —OH, a lower alkoxy, a lower acyloxy, an unsubstituted or substituted amino acid residue or salt thereof, but are not each —OH simultaneously, and R5 and R6 independently represent —H or an alkyl;
- and
- (b) administering an effective amount of the composition to the subject.
Dependencies are inferred from the claim text.