Method for inducing a sustained immune response

Abstract

A method for inducing a sustained immune response in humans or animal patient suffering from human immunodeficiency virus (HIV) acquired immune deficiency syndrome (AIDS, autoimmune disease, cancer, inflammation, and neurodegenerative diseases comprises daily administration to such patients a single oral tablet, rapidly dissolving film, capsule, liquid or cream dose of an Immediate release naltrexone composition comprising between about 0.01 to about 10 mg of naltrexone. In order to provide a benefit the naltrexone must be an Immediate release composition comprising between about 0.01 and about 10 mg of naltrexone.

What is claimed is: 
     
         1 . A method for inducing sustained immune response in a mammalian subject in need thereof, comprising administering to the subject an immediate release pharmaceutical composition comprising naltrexone or a solvate, hydrate, enantiomer, diastereomer, N-oxide or pharmaceutically acceptable salt thereof in an amount between about 0.01 mg and about 10.0 mg. 
     
     
         2 . The method of  claim 1 , wherein the pharmaceutical composition comprises the enantiomer. 
     
     
         3 . The method of  claim 2 , wherein the pharmaceutical composition further comprises a second active agent. 
     
     
         4 . The method of  claim 3 , wherein the second active agent comprises an anti-cancer agent. 
     
     
         5 . The method of  claim 4 , wherein the anti-cancer agent is selected from the group consisting of abarelix, aldesleukin, alemtuzumab, alitretinoin, allopurinol, altretamine, amifostine, anastrozole, arsenic trioxide, asparaginase, azacitidine, BCG Live, bevacuzimab, fluorouracil, bexarotene, bleomycin, bortezomib, busulfan, calusterone, capecitabine, camptothecin, carboplatin, carmustine, celecoxib, cetuximab, chlorambucil, cisplatin, cladribine, clofarabine, cyclophosphamide, cytarabine, dactinomycin, darbepoetin alfa, daunorubicin, denileukin, dexrazoxane, docetaxel, doxorubicin (neutral), doxorubicin hydrochloride, dromostanolone propionate, epirubicin, epoetin alfa, erlotinib, estramustine, etoposide phosphate, etoposide, exemestane, filgrastim, floxuridine fludarabine, fulvestrant, gefitinib, gemcitabine, gemtuzumab, goserelin acetate, histrelin acetate, hydroxyurea, ibritumomab, idarubicin, ifosfamide, imatinib mesylate, interferon alfa-2a, interferon alfa-2b, irinotecan, lenalidomide, letrozole, leucovorin, leuprolide acetate, levamisole, lomustine, megestrol acetate, melphalan, mercaptopurine, 6-MP, mesna, methotrexate, methoxsalen, mitomycin C, mitotane, mitoxantrone, nandrolone, nelarabine, nofetumomab, oprelvekin, oxaliplatin, paclitaxel, palifermin, pamidronate, pegademase, pegaspargase, pegfilgrastim, pemetrexed disodium, pentostatin, pipobroman, plicamycin, porfimer sodium, procarbazine, quinacrine, rasburicase, rituximab, sargramostim, sorafenib, streptozocin, sunitinib maleate, talc, tamoxifen, temozolomide, teniposide, VM-26, testolactone, thioguanine, 6-TG, thiotepa, topotecan, toremifene, tositumomab, trastuzumab, tretinoin, ATRA, uracil mustard, valrubicin, vinblastine, vincristine, vinorelbine, zoledronate, and zoledronic acid. 
     
     
         6 . The method of  claim 1 , wherein the need is selected from the group consisting of treating or preventing viral infection, treating or preventing cancer, treating or preventing an autoimmune and inflammatory disease, treating or preventing a disorder of the central nervous system, treating or preventing a cardiovascular disorder, modulating telomers, and inhibiting angiogenesis. 
     
     
         7 . The method of  claim 6 , wherein the pharmaceutical composition comprises the enantiomer. 
     
     
         8 . The method of  claim 7 , wherein the need is treating or preventing a cardiovascular disorder. 
     
     
         9 . The method of  claim 8 , wherein the cardiovascular disorder is chosen from the group consisting of myocardial infarction, stroke, thrombosis, hypertension, heart failure, cardiomyopathy, myocarditis, vascular stenosis, restenosis, atherosclerosis and arterial hyperplasia, and said administering is once in a 24 hour period. 
     
     
         10 . The method of  claim 9 , wherein the amount is between about 1.0 mg and about 8.0 mg, about 0.05 mg and about 6.0 mg, or about 0.05 mg and about 4.5 mg. 
     
     
         11 . The method of  claim 7 , wherein the need is treating or preventing a disorder of the central nervous system. 
     
     
         12 . The method of  claim 11 , wherein the disorder of the central nervous system is selected from the group consisting of schizophrenia, schizoaffective disorders, schizophreniform disorders, delusional syndromes, psychotic conditions related to taking of psychoactive substances, psychotic conditions not related to taking psychoactive substances, affective disorder, bipolar disorder, mania, depression, anxiety disorders, stress reactions, consciousness disorders, coma, delirium, delirium of alcoholic aetiology, aggression, psychomotor agitation, conduct disorders, sleep disorders, withdrawal syndromes, addiction, pain syndromes, intoxication with psychoactive substances, cerebral circulatory disorders, psychosomatic disorders, conversion disorders, dissociative disorders, urination disorders, autism, developmental disorders, nocturia, stuttering, tics, cognitive disorders, Alzheimer's disease, and Parkinson disease. 
     
     
         13 . The method of  claim 11 , where the amount is between about 0.01 mg and about 10.0 mg, about 0.01 mg and about 8.0 mg, about 0.01 mg and about 6.0 mg, and about 0.01 mg and about 4.5 mg. 
     
     
         14 . The method of  claim 7 , wherein the need is modulating telomers. 
     
     
         15 . The method of  claim 2 , wherein said administering is once in a 24 hour period. 
     
     
         16 . The method of  claim 2 , wherein the mammalian subject is a human. 
     
     
         17 . The method of  claim 2 , wherein said pharmaceutically acceptable salt thereof is a hydrochloride salt. 
     
     
         18 . The method of  claim 2 , wherein said immediate release pharmaceutical composition releases the enantiomer or pharmaceutically acceptable salt thereof completely within about 60 minutes. 
     
     
         19 . The method of  claim 2 , wherein said administering is chosen from the group consisting of oral, sublingual, subcutaneous, intramuscular, intravenous, topical, local, intratracheal, intranasal, transdermal and rectal administration. 
     
     
         20 . The method of  claim 2 , wherein said immediate release pharmaceutical composition is in the form of a capsule or tablet.