Methods for stimulating hair growth by administering BMPs

• US 20060239951A1
• Filed: 03/30/2006
• Published: 10/26/2006
• Est. Priority Date: 03/30/2005
• Status: Abandoned Application

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Leslie, Kieron, Kilbourne, Edward J., Valentin, Alexandre, Wozney, John
• Application Number:
  US11/393,498
• Publication Number:
  US 20060239951A1
• Time in Patent Office: Days
• US Class Current: 424/70.140
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/13 Cyclosporins
• CPC Class Codes: A61K 38/1875 Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/08 for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 17/14 for baldness or alopecia
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 21/04 for myasthenia gravis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/18 : Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 27/02 : Ophthalmic agents
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 29/02 : without antiinflammatory effect
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/14 : of the thyroid hormones, e.g. T3, T4
• CPC Class Codes: A61P 5/40 : Mineralocorticosteroids, e.g. aldosterone; Drugs increasing or potentiating the activity of mineralocorticosteroids
• CPC Class Codes: A61P 7/00 : Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 7/04 : Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: A61P 7/06 : Antianaemics
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/14 : Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

Methods and compositions for stimulating hair growth and inhibiting immune system activity by administering BMPs are provided. The methods and compositions can be used for treating or preventing disorders resulting in loss of hair, as well as a wide range of autoimmune disorders.

Claims

1. A method of treating a hair loss disorder comprising:

(a) identifying a patient suffering from a hair loss disorder;

(b) administering a composition comprising a therapeutically effective amount of at least one BMP chosen from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and MP52/GDF-5; and

(c) allowing the at least one active agent to promote hair growth.

2. The method of claim 1, wherein the hair loss disorder is chosen from the group comprising:

alopecia areata, alopecia totalis, alopecia universalis, androgenic alopecia, telogen effluvium, anagen effluvium, and chemotherapy-induced alopecia.

3. The method of claim 1, wherein the composition comprises a therapeutically effective amount of BMP-2.

4. The method of claim 1, wherein the composition comprises a therapeutically effective amount of BMP-4.

5. The method of claim 1, wherein the composition comprises a therapeutically effective amount of BMP-2 and a therapeutically effective amount of BMP-4.

6. The method of claim 1, wherein the subject is a mammal.

7. The method of claim 1, wherein the subject is a human.

8. The method of claim 1, wherein the composition is administered by injection, intraosseously, intravenously, parenterally, percutaneously or extra-corporeally.

9. The method of claim 1, wherein the therapeutically effective amount of at least one BMP is chosen from about 0.05 to about 500 mg, from about 0.5 to about 50 mg, from about 1 to about 25 mg, and from about 5 to about 10 mg.

10. The method of claim 1, wherein the therapeutically effective amount of at least one BMP is administered at a concentration chosen from about 0.001 mg/ml to about 100 mg/ml, from about 0.01 mg/ml to about 50 mg/ml, from about 0.1 mg/ml to about 25 mg/ml, and from about 1 mg/ml to about 5 mg/ml.

11. The method of claim 1, wherein the therapeutically effective amount of at least one BMP is administered to the subject at intervals chosen from:

daily, weekly, monthly, bimonthly, tri-monthly, biannually, and annually.

12. The method of claim 1, wherein the therapeutically effective amount of at least one BMP is administered to the subject for a period of time chosen from:

about 1 to about 4 weeks, about 5 to about 24 weeks, about 25 to about 52 weeks, about 1 to about 2 years, about 2 to about 5 years, about 5 to about 10 years and about 10 to about 20 years.

13. The method of claim 2, wherein the hair loss disorder is alopecia areata, alopecia totalis, or alopecia universalis.

14. A method of treating a hair loss disorder comprising:

(a) identifying a patient suffering from a hair loss disorder;

(b) administering a composition comprising a therapeutically effective amount of at least one BMP chosen from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and MP52/GDF-5;

(c) administering a therapeutically effective amount of at least one compound chosen from the group consisting of prednisone, dexamethisone, hydrocortisone, cyclosporin A, pimecrolimus, tacrolimus, minoxidil, and finasteride; and

(d) allowing the active agents to promote hair growth.

15. A method of treating an autoimmune disorder comprising:

(a) identifying a patient suffering from an autoimmune disorder;

(b) administering a composition comprising a therapeutically effective amount of at least one BMP chosen from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and MP52/GDF-5; and

(c) allowing the at least one BMP to inhibit immune system activity.

16. The method of claim 15, wherein the autoimmune disorder is chosen from the group comprising:

ankylosing spondylitis, antiphospholipid syndrome, Addison'"'"'s Disease, autoimmune hemolytic anemia, autoimmune hepatitis, autoimmune lymphoproliferative syndrome (ALPS), autoimmune thrombocytopenic purpura (ATP), Behcet'"'"'s Disease, bulbous pemphigoid, cardiomyopathy, celiac disease, Dermatitis Herpetiformis, chronic fatigue immune dysfunction syndrome (CFIDS), chronic inflammatory demyelinating polyneuropathy (CIDP), cicatricial pemphigoid, systemic sclerosis (CREST Syndrome), cold agglutinin disease, Crohn'"'"'s Disease, cutaneous vasculitis, Degos'"'"' Disease, dermatomyositis, juvenile dermatbmyositis, discoid lupus erythematosus, essential mixed cryoglobulinemia, fibromyalgia, Goodpasture'"'"'s Syndrome, Graves'"'"' Disease, Guillain-Barre Syndrome, Hashimoto'"'"'s Thyroiditis, idiopathic pulmonary fibrosis, idiopathic thrombocytopenia purpura (ITP), immunoglobulin A nephropathy, inflammatory arthritis, insulin-dependent diabetes mellitus, juvenile arthritis, Kawasaki'"'"'s Disease, lichen planus, membranous glomerulonephritis, Mé

niè

re'"'"'s Disease, mixed connective tissue disease, multifocal motor neuropathy, multiple sclerosis, myasthenia gravis, osteoarthritis, pemphigus vulgaris, pernicious anemia, polyarteritis nodosa, polychondritis, polyglandular syndrome, polymyalgia rheumatica, polymyositis and dermatomyositis, primary agammaglobulinemia, primary biliary cirrhosis, psoriasis, psoriatic arthritis, Raynaud'"'"'s Phenomenon, Reiter'"'"'s Syndrome, rheumatic fever, rheumatoid arthritis, sarcoidosis, scleroderma, Sjö

gren'"'"'s Syndrome, Stiff-Man Syndrome, systemic lupus erthryomatosus, Takayasu arteritis, temporal arteritis/giant cell arteritis, ulcerative colitis, uveitis, vasculitis, vitiligo, and Wegener'"'"'s Granulomatosis.

17. The method of claim 15, wherein the composition comprises a therapeutically effective amount of BMP-2.

18. The method of claim 15, wherein the composition comprises a therapeutically effective amount of BMP-4.

19. The method of claim 15, wherein the composition comprises a therapeutically effective amount of BMP-2 and a therapeutically effective amount of BMP-4.

20. The method of claim 15, wherein the subject is a mammal.

21. The method of claim 15, wherein the subject is a human.

22. The method of claim 15, wherein the composition is administered by injection, intraosseously, intravenously, parenterally, percutaneously or extra-corporeally.

23. The method of claim 15, wherein the therapeutically effective amount of at least one BMP is chosen from about 0.05 to about 500 mg, from about 0.5 to about 50 mg, from about 1 to about 25 mg, and from about 5 to about 10 mg.

24. The method of claim 15, wherein the therapeutically effective amount of at least one BMP is administered at a concentration chosen from about 0.001 mg/ml to about 100 mg/ml, from about 0.01 mg/ml to about 50 mg/ml, from about 0.1 mg/ml to about 25 mg/ml, and from about 1 mg/ml to about 5 mg/ml.

25. The method of claim 15, wherein the therapeutically effective amount of at least one BMP is administered to the subject at intervals chosen from:

daily, weekly, monthly, bimonthly, tri-monthly, biannually, and annually.

26. The method of claim 15, wherein the therapeutically effective amount of at least one BMP is administered to the subject for a period of time chosen from:

about 1 to about 4 weeks, about 5 to about 24 weeks, about 25 to about 52 weeks, about 1 to about 2 years, about 2 to about 5 years, about 5 to about 10 years and about 10 to about 20 years.

27. The method of claim 16, wherein the autoimmune disorder is Crohn'"'"'s disease, inflammatory bowel disease, multiple sclerosis, psoriasis, rheumatoid arthritis, or systemic lupus erythematosus.

28. A method of treating an autoimmune disorder comprising:

(a) identifying a patient suffering from an autoimmune disorder;

(b) administering a composition comprising a therapeutically effective amount of at least one BMP chosen from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and MP52/GDF-5;

(c) administering a therapeutically effective amount of at least one compound chosen from the group consisting of cyclosporin A, pimecrolimus, tacrolimus, azathioprine, mycophenolate mofetil, rapamycin, CCI-779, methotrexate, leflunomide, interferon-β

, copaxone, budenoside, epidermal growth factor, sulfasalazine, 6-mercaptopurine, azathioprine, metronidazole, mesalamine, olsalazine, ciprofloxacin, and lignocaine; and

(d) allowing the BMPs to inhibit immune system activity.

29. A pharmaceutical composition comprising:

(a) at least one BMP chosen from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and MP52/GDF-5;

(b) a sterile solution of 0.5% sucrose, 2.5% glycine, 5 mM L-glutamic acid, 5 mM NaCl, and 0.01% polysorbate 80, at pH 4.50.

30. A pharmaceutical composition for promoting hair growth comprising:

(a) at least one BMP chosen from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and MP52/GDF-5; and

(b) at least one compound chosen from the group consisting of prednisone, dexamethisone, hydrocortisone, cyclosporin A, pimecrolimus, tacrolimus, minoxidil, and finasteride.

31. A pharmaceutical composition for inhibiting immune system activity comprising:

(a) at least one BMP chosen from the group consisting of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, and MP52/GDF-5,

(b) and at least one compound chosen from the group consisting of cyclosporin A, pimecrolimus, tacrolimus, azathioprine, mycophenolate mofetil, rapamycin, CCI-779, methotrexate, leflunomide, interferon-β

, copaxone, budenoside, epidermal growth factor, sulfasalazine, 6-mercaptopurine, azathioprine, metronidazole, mesalamine, olsalazine, ciprofloxacin, and lignocaine.