Compositions to improve the therapeutic benefit of suboptimally administered chemical compounds including substituted hexitols such as dianhydrogalactitol and diacetyldianhydrogalactitol

1. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises a drug combination comprising:

(a) dianhydrogalactitol or diacetyldianhydrogalactitol; and

(b) an additional therapeutic agent selected from the group consisting of:

(i) topoisomerase inhibitors;

(ii) fraudulent nucleosides;

(iii) fraudulent nucleotides;

(iv) thymidylate synthetase inhibitors;

(v) signal transduction inhibitors;

(vi) cisplatin or platinum analogs;

(vii) alkylating agents;

(viii) anti-tubulin agents;

(ix) antimetabolites;

(x) berberine;

(xi) apigenin;

(xii) amonafide;

(xiii) vinca alkaloids;

(xiv) 5-fluorouracil;

(xv) curcumin;

(xvi) NF-κB inhibitors;

(xvii) rosmarinic acid;

(xviii) mitoguazone; and

(xix) tetrandrine.

2. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises:

(a) dianhydrogalactitol or diacetyldianhydrogalactitol; and

(b) a therapeutic agent subject to chemosensitization selected from the group consisting of:

(i) topoisomerase inhibitors;

(ii) fraudulent nucleosides;

(iii) fraudulent nucleotides;

(iv) thymidylate synthetase inhibitors;

(v) signal transduction inhibitors;

(vi) cisplatin or platinum analogs;

(vii) alkylating agents;

(viii) anti-tubulin agents;

(ix) antimetabolites;

(x) berberine;

(xi) apigenin;

(xii) amonafide;

(xiii) vinca alkaloids;

(xiv) 5-fluorouracil;

(xv) curcumin;

(xvi) NF-κB inhibitors;

(xvii) rosmarinic acid;

(xviii) mitoguazone; and

(xix) tetrandrine;

wherein the dianhydrogalactitol or diacetyldianhydrogalactitol acts as a chemosensitizer.

3. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises:

(a) dianhydrogalactitol or di acetyl dianhydrogalactitol; and

(b) a therapeutic agent subject to chemopotentiation selected from the group consisting of:

(i) topoisomerase inhibitors;

(ii) fraudulent nucleosides;

(iii) fraudulent nucleotides;

(iv) thymidylate synthetase inhibitors;

(v) signal transduction inhibitors;

(vi) cisplatin or platinum analogs;

(vii) alkylating agents;

(viii) anti-tubulin agents;

(ix) antimetabolites;

(x) berberine;

(xi) apigenin;

(xii) amonafide;

(xiii) vinca alkaloids;

(xiv) 5-fluorouracil;

(xv) curcumin;

(xvi) NF-κB inhibitors;

(xvii) rosmarinic acid;

(xviii) mitoguazone;

(xix) tetrandrine; and

(xx) biotherapeutics;

wherein the dianhydrogalactitol or diacetyldianhydrogalactitol acts as a chemopotentiator.

4. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises a therapeutic agent that is dianhydrogalactitol or diacetyldianhydrogalactitol and the composition also comprises a diluent, wherein the diluent is selected from the group consisting of:

(i) an emulsion;

(ii) N-methylformamide (NMF);

(iii) DMF;

(iv) ethanol;

(v) benzyl alcohol;

(vi) dextrose-containing water for injection;

(vii) Cremophor;

(viii) cyclodextrin; and

(ix) PEG.

5. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises a therapeutic agent that is dianhydrogalactitol or diacetyldianhydrogalactitol and the composition also comprises a solvent system, wherein the solvent system is selected from the group consisting of:

(i) an emulsion;

(ii) N-methylformamide (NMF);

(iii) DMF;

(iv) ethanol;

(v) benzyl alcohol;

(vi) dextrose-containing water for injection;

(vii) Cremophor;

(viii) cyclodextrin; and

(ix) PEG.

6. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises a therapeutic agent that is dianhydrogalactitol or diacetyldianhydrogalactitol and the composition also comprises an excipient, wherein the excipient is selected from the group consisting of:

(i) mannitol;

(ii) albumin;

(iii) EDTA;

(iv) sodium bisulfite;

(v) benzyl alcohol;

(vi) a carbonate buffer; and

(vii) a phosphate buffer.

7. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises a therapeutic agent that is dianhydrogalactitol or diacetyldianhydrogalactitol and wherein the dianhydrogalactitol or diacetyldianhydrogalactitol is incorporated into a dosage form selected from the group consisting of:

(i) tablets;

(ii) capsules;

(iii) topical gels;

(iv) topical creams;

(v) patches;

(vi) suppositories; and

(vii) lyophilized dosage fills.

8. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises a therapeutic agent that is dianhydrogalactitol or diacetyldianhydrogalactitol and the composition also comprises a drug delivery system selected from the group consisting of:

(i) nanocrystals;

(ii) bioerodible polymers;

(iii) liposomes;

(iv) slow release injectable gels; and

(v) microspheres.

9. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises a therapeutic agent that is dianhydrogalactitol or diacetyldianhydrogalactitol and the dianhydrogalactitol or diacetyldianhydrogalactitol is present in the composition in a drug conjugate form selected from the group consisting of:

(i) a polymer system;

(ii) polylactides;

(iii) polyglycolides;

(iv) amino acids;

(v) peptides; and

(vi) multivalent linkers.

10. A composition to improve the efficacy and/or reduce the side effects of suboptimally administered drug therapy, wherein the composition possesses increased efficacy or reduced side effects for cancer therapy, wherein the composition comprises a therapeutic agent that is dianhydrogalactitol or diacetyldianhydrogalactitol and the dianhydrogalactitol or diacetyldianhydrogalactitol is in the form of a prodrug system, wherein the prodrug system is selected from the group consisting of:

(i) the use of enzyme sensitive esters;

(ii) the use of dimers;

(iii) the use of Schiff bases;

(iv) the use of pyridoxal complexes; and

(v) the use of caffeine complexes.