Claims for Patent: 10,076,555

Summary for Patent: 10,076,555

Title:	Methods of inducing melanogenesis in a subject
Abstract:	Described herein are methods and compositions for inducing melanogenesis in a human subject. The method comprises administering to a subject an alpha-MSH analogue, in an effective amount and time to induce melanogenesis by the melanocytes in epidermal tissue of subject without inducing homologous desensitization of the melanocortin-1 receptors.
Inventor(s):	Kleinig; Michael John (Brunswick, AU), Tice; Thomas R. (Indian Springs, AL), Staas; Jay K. (Marylene, AL)
Assignee:	Clinuvel Pharmaceuticals Limited (Melbourne, AU)
Application Number:	15/135,241
Patent Claims:	1. A method for inducing melanogenesis in a human subject comprising administering to the subject an alpha-MSH analogue in an effective amount and time to induce melanogenesis by melanocytes in epidermal tissue of the subject, wherein the alpha-MSH analogue is [Nle.sup.4, D-Phe.sup.7]-alpha-MSH, wherein the alpha-MSH analogue is administered in a delivery system that releases the alpha-MSH analogue in the subject for at least 2 days, and wherein the alpha-MSH analogue is administered at a level not exceeding 10 ng/ml in plasma of the subject for a period of at least 24 hours. 2. A method for reducing occurrence of UV radiation-induced skin damage in a human subject comprising administering to the subject an alpha-MSH analogue in an effective amount and time to induce melanogenesis by melanocytes in epidermal tissue of the subject, wherein the alpha-MSH analogue is [Nle.sup.4, D-Phe.sup.7]-alpha-MSH, wherein the alpha-MSH analogue is administered in a delivery system that releases the alpha-MSH analogue in the subject for at least 2 days, and wherein the alpha-MSH analogue is administered at a level not exceeding 10 ng/ml in plasma of the subject for a period of at least 24 hours. 3. The method of claim 1, wherein the delivery system comprises up to 20 mg of alpha-MSH analogue. 4. The method of claim 1, wherein the delivery system comprises from 5 mg of alpha-MSH analogue. 5. The method of claim 1, wherein the delivery system comprises from 10 mg to 20 mg of alpha-MSH analogue. 6. The method of claim 1, wherein the alpha-MSH analogue is released for at least 4 days. 7. The method of claim 1, wherein the alpha-MSH analogue is released for at least 6 days. 8. The method of claim 1, wherein the level is not exceeding 2 ng/ml in the plasma of the subject. 9. The method of claim 1, wherein the period is at least 2 days. 10. The method of claim 1, wherein the period is at least 4 days. 11. The method of claim 1, wherein the delivery system comprises from 5 to 60% of alpha-MSH analogue. 12. The method of claim 1, wherein the delivery system is administered subcutaneously. 13. The method of claim 1, wherein the delivery system is a rod or implant. 14. The method of claim 2, wherein the delivery system comprises up to 20 mg of alpha-MSH analogue. 15. The method of claim 2, wherein the delivery system comprises from 5 mg of alpha-MSH analogue. 16. The method of claim 2, wherein the delivery system comprises from 10 mg to 20 mg of alpha-MSH analogue. 17. The method of claim 2, wherein the alpha-MSH analogue is released for at least 4 days. 18. The method of claim 2, wherein the level is not exceeding 2 ng/ml in the plasma of the subject. 19. The method of claim 2, wherein the period is at least 4 days. 20. The method of claim 2, wherein the delivery system is administered subcutaneously. 21. The method of claim 1, wherein the delivery system comprises an extended release formulation. 22. The method of claim 2, wherein the delivery system comprises an extended release formulation.