ACTH FOR TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS
Provided herein are methods of treatment of Amyotrophic Lateral Sclerosis comprising administration of adrenocorticotropic hormone (ACTH), or fragment, analog, complex or aggregate thereof, or any combination thereof, to an individual in need thereof.
1 . Use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, for treating an individual diagnosed with, suspected of having, or predisposed to Amyotrophic Lateral Sclerosis (ALS), wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered as a first dose and one or more subsequent doses.
2 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of claim 1 , wherein the ALS is sporadic ALS, or familial type ALS.
3 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of claim 1 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered in early stage ALS upon onset of muscle weakness in the limbs and/or slurred and nasal speech.
4 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of claim 1 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered upon detection of a mutation in the SOD1 gene.
5 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of claim 1 , wherein the first dose of ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, comprises a dose between about 10 IU and about 150 IU, and the one or more subsequent doses of ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered about every day, about every 2 days, about every 5 days, about every week, about every two weeks, about every three weeks, about every month, about every two months, or any combination thereof.
6 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of claim 1 , wherein the first dose of ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, comprises a dose between about 10 IU and about 150 IU, and the one or more subsequent doses of ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, are between about 20%-80% of the first dose.
7 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of claim 1 , wherein the doses of ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, are administered every 2 days.
8 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of claim 1 , wherein the doses of ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, are administered every 7 days.
9 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a ACTH 1-39 peptide having the formula:
H-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-
1 2 3 4 5 6 7 8 9 10
Lys-Pro-Val-Gly-Lys-Lys-Arg-Arg-Pro-Val-
11 12 13 14 15 16 17 18 19 20
Lys-Val-Try-Pro-Asp-Gly-Ala-Glu-Asp-Gln-
21 22 23 24 25 26 27 28 29 30
Leu-Ala-Glu-Ala-Phe-Pro-Leu-Glu-Phe-OH
31 32 33 34 35 36 37 38 39
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
10 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a ACTH 1-13 peptide (alpha-MSH) having the formula:
H-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-
1 2 3 4 5 6 7 8 9 10
Lys-Pro-Val
11 12 13
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
11 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a ACTH 1-24 peptide having the formula:
H-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-
1 2 3 4 5 6 7 8 9 10
Lys-Pro-Val-Gly-Lys-Lys-Arg-Arg-Pro-Val-
11 12 13 14 15 16 17 18 19 20
Lys-Val-Try-Pro
21 22 23 24
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
12 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a ACTH 1-17 peptide having the formula:
H-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-
1 2 3 4 5 6 7 8 9 10
Lys-Pro-Val-Gly-Lys-Lys-Arg-
11 12 13 14 15 16 17
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
13 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a ACTH 4-10 peptide of formula:
Met-Glu-His-Phe-Arg-Trp-Gly
4 5 6 7 8 9 10
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
14 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a ACTH 4-9 peptide analog of formula:
Met-Glu-His-Phe-D-Lys-Phe-OH
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
15 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a fragment of formula:
Ac-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-Lys-
Pro-Val
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
16 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a fragment of formula:
H-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-Lys-
Pro-Val
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
17 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a fragment of formula:
D-Ala-Gln-Tyr-Phe-Arg-Trp-Gly-NH 2 .
or a fragment, complex, aggregate, or analog thereof, or any combination thereof.
18 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered as an ACTH preparation.
19 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered as a prodrug.
20 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered as a modified release formulation.
21 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered as an immediate release formulation.
22 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered intramuscularly.
23 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered subcutaneously.
24 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is administered orally.
25 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a porcine ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof.
26 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a human ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof.
27 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 8 , wherein the ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof, is a recombinant ACTH peptide or fragment, analog, complex or aggregate thereof, or any combination thereof.
28 . The use of adrenocorticotropic hormone (ACTH) peptide, or fragment, analog, complex or aggregate thereof, or any combination thereof, of any one of claims 1 - 27 , further comprising administration of a second therapeutic agent selected from riluzole, ceftriaxone, methylcobalamine, Aeolus 10150, edaravone, hepatocyte growth factor (HGF), insulin growth factor (IGF), Atorvastatin, Lithium carbonate, Avanier 07-ACR-123 (Zenvia®), SB-509, Talampanel, Thalidomide, Arimoclomol, Olanzapine, KNS-760704, memantine, tamoxifen, ONO-2506PO, MCI-186, pioglitazone, ALS-357, creatine monohydrate, TCH346, Botulinum toxin type B, tauroursodeoxycholic acid, Dronabinol, coenzyme Q10, YAM80, Olesoxime, escitalopram (Lexapro®), sodium phenylbutyrate, ISIS 333611, granulocyte stimulating factor, neuronal growth factor (NGF), brain-derived neutrophic factor (BDNF), neutrophin 3 (NT3), basic fibroblast growth factor (bFGF), R(+) pramipexole dihydrochloride monohydrate, Sodium Valproate, AVP-923, sNN0029, Antithymocyte globulin, cyclosporin, corticosteroids, modafinil, or anti-CD40L, wherein the second therapeutic agent is administered sequentially or simultaneously.