Biological agent compositions

• US 5,840,319 A
• Filed: 10/15/1997
• Issued: 11/24/1998
• Est. Priority Date: 10/08/1992
• Status: Expired due to Term

• Current Assignee: Supratek Pharma, Inc.
• Original Assignee: Alexander V. Kabonov, Eugenii S. Severin, Peter G. Sveshnikov, Valery Y.U. Alakhov
• Inventors: Sveshnikov, Peter G., Severin, Eugenii S., Kabonov, Alexander V., Alakhov, Valery Yu
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): FAULKNER, DIEDRA SARRAE
• Application Number:
  US08/951,079
• Time in Patent Office: 405 Days
• Field of Search: 424/400, 424/422, 424/450, 514/772.5, 514/772.6, 514/772.7
• US Class Current: 424/400
• CPC Class Codes: A61K 9/1075 Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers A61K9/0026 takes precedence

Abstract

Novel pharmaceutical compositions comprising a chemotherapeutic agent and a polyether block copolymer, and methods of treatment using the compositions.

Claims

1. A method of treating a subject, wherein the subject has resistance to a biological agent, the method comprising administering a composition comprising the biological agent and a micelle forming copolymer composition having a CMC of no more than about 0.5% wt/vol at 37°

C. in an isotonic aqueous solution.

2. The method of claim 1, wherein the copolymer composition has a CMC of no more than about 0.05% wt/vol at 37°

C. in an isotonic aqueous solution.

3. The method of claim 2, wherein the copolymer composition has a CMC of no more than about 0.01% wt/vol at 37°

C. in an isotonic aqueous solution.

11. A method of treating a cancer comprising administering to an animal in need of treatment an anti-cancer effective amount of the composition of claim 1.

12. A method of treating a microbial infection comprising administering to an animal in need of treatment an antimicrobial effective amount of the composition of claim 1.

13. A method of inhibiting or preventing tumor metastases comprising administering at tumor metastasis inhibiting or preventing amount of the composition of claim 1.

14. A method of treating cancer comprising administering an anticancer effective amount of the composition of claim 1.

15. The method of treating cancer of claim 14, wherein the cancer is a leukemia, breast cancer, ovarian cancer, pancreatic cancer, lung cancer, myoloma, melanoma, glioma or astrocytoma.

16. The method of treating cancer of claim 15, wherein the cancer is a Hodgkin'"'"'s lymphoma, non-Hodgkin'"'"'s lymphoma, acute lymphocytic lymphoma, acute mylocytic lymphoma, acute non-lymphatic leukemia, Karposi'"'"'s sarcoma, small-cell lung cancer, non-small cell lung cancer or glial astrocytoma.

4. A method of treating a subject, wherein the subject has resistance to a biological agent, the method comprising administering a composition comprising the biological agent and a copolymer comprising an A-type linear polymeric segment, the repeating units of which contribute an average Hansch-Leo fragmental constant of about -0.4 or less, joined at one end to a B-type linear polymeric segment, the repeating units of which contribute an average Hansch-Leo fragmental constant of about -0.4 or more.

5. The method of claim 4, wherein the hydrophobe weight percentage of the polyether block copolymer of the administered composition is at least about 50%.

6. The composition of claim 5, wherein the hydrophobe weight percentage of the polyether block copolymer of the administered composition is at least about 60%.

7. The composition of claim 4, wherein the hydrophobe molecular weight of the polyether block copolymer of the administered composition is at least about 900.

8. The composition of claim 7, wherein the hydrophobe molecular weight of the polyether block copolymer of the administered composition is at least about 1700.

9. The composition of claim 8, wherein the hydrophobe molecular weight of the polyether block copolymer of the administered composition is at least about 2000 and the hydrophobe weight percentage is at least about 20%.

10. The composition of claim 9, wherein the hydrophobe molecular weight of the polyether block copolymer of the administered composition is at least about 2300 and the hydrophobe weight percentage is at least about 20%.

17. A composition to overcome multidrug resistance in cancer cells to cytotoxic drugs, comprising an effective amount of at least one cytotoxic drug from the group consisting of anthracycline and drugs related to multidrug resistance solubilized in non-toxic, pharmaceutically acceptable polymeric micelles.

18. A method to overcome multidrug resistance in cancer cells to cytotoxic drug in the treatment of cancer with the cytotoxic drugs, comprising administering to a patient in chemotherapy an effective amount of at least one cytotoxic drug solubilized in non-toxic, pharmaceutically acceptable polymeric micelles.