A formulation, a pharmaceutical composition or a therapeutic combination for use in a method for treating, ameliorating, preventing, reversing or decreasing the severity or duration of:
- neuropathic pain,
- inflammation-induced neuropathic pain,
- wherein optionally the inflammation-induced neuropathic pain comprises a Toll-like receptor 4 (TLR4)-mediated inflammation-induced neuropathic pain,
- nerve or CNS inflammation,
- wherein optionally the nerve or CNS inflammation comprises a TLR4-mediated nerve or CNS inflammation,
- allodynia,
- wherein optionally the allodynia comprises a TLR4-mediated allodynia,
- a post nerve or tissue injury pain or neuropathic pain,
- wherein optionally the post nerve or tissue injury pain or neuropathic pain is generated or caused by, or is a sequelae to, trauma, chemotherapy, arthritis, diabetes, or viral infection,
- post-surgical pain or neuropathic pain,
- chemotherapeutic-induced peripheral neuropathy (CIPN), wherein optionally the CIPN is a cisplatin-induced CIPN or allodynia,
- a neurodegenerative disease or condition, optionally a chronic or progressive neurodegenerative disease or condition, optionally Alzheimer's disease or a Chronic Traumatic Encephalopathy (CTE) or a related tauopathy, a traumatic brain injury (TBI), a posttraumatic stress disorder, a traumatic war neurosis, or a post-traumatic stress syndrome (PTSS),
- a primary headache, optionally a migraine or a cluster headache, and/or
- hyperalgesia,
- wherein the formulation or a therapeutic combination comprises one of, all or several of:
- (i) an ApoA-I Binding Protein (APOA1BP, AIBP, or AI-BP) polypeptide compound or composition, or a compound that increases expression or activity of, or encodes, a APOA1BP polypeptide or nucleic acid, or a polypeptide or peptide having an APOA1BP activity, or an APOA1BP-stimulating compound or composition;
- (ii) the formulation or pharmaceutical composition of (i), wherein the compound that increases expression or activity of, or encodes, a APOA1BP polypeptide is a nucleic acid that expresses or encodes a APOA1BP polypeptide or a polypeptide having a APOA1BP polypeptide activity,
- and optionally a APOA1BP-stimulating compound or composition increases or or activates the activity of a APOA1BP promoter or transcriptional regulatory sequence or motif,
- and optionally the nucleic acid that expresses or encodes a APOA1BP polypeptide or a polypeptide having a APOA1BP polypeptide activity is contained in an expression vehicle, vector, recombinant virus, or equivalent, and optionally the vector or virus is or comprises an adenovirus vector or an adeno-associated virus (AAV) vector, a retrovirus, a lentiviral vector, a herpes simplex virus, a human immunodeficiency virus (HIV), or a synthetic vector,
- and optionally the AAV vector comprises or is:
- an adeno-associated virus (AAV), or an adenovirus vector,
- an AAV serotype or variant AAV5, AAV6, AAV8 or AAV9, AAV-DJ or AAV-DJ/8™ (Cell Biolabs, Inc., San Diego, Calif.),
- a rhesus-derived AAV, or the rhesus-derived AAV AAVrh.10hCLN2,
- an AAV capsid mutant or AAV hybrid serotype,
- an organ-tropic AAV, or a cardiotropic AAV, or a cardiotropic AAVM41 mutant,
- wherein optionally the AAV is engineered to increase efficiency in targeting a specific cell type that is non-permissive to a wild type (wt) AAV and/or to improve efficacy in infecting only a cell type of interest,
- and optionally the hybrid AAV is retargeted or engineered as a hybrid serotype by one or more modifications comprising:
- 1) a transcapsidation, 2) adsorption of a bi-specific antibody to a capsid surface, 3) engineering a mosaic capsid, and/or 4) engineering a chimeric capsid;
- (iii) an ApoA-I Binding Protein (APOA1BP, AIBP, or AI-BP)-inducing compound or composition;
- (iv) the formulation or pharmaceutical composition of any of (i) to (iii), wherein the an ApoA-I Binding Protein (APOA1BP, AIBP, or AI-BP) polypeptide or protein is a human or a mammalian APOA1BP, or a AIBP1 or a AIBP2, or a recombinant, peptidomimetic or a synthetic APOA1BP, or a bioisostere of an ApoA-I Binding Protein (APOA1BP, AIBP, or AI-BP);
- (v) the formulation or pharmaceutical composition of any of (i) to (iv), formulated for administration in vivo;
- or formulated for enteral or parenteral administration, or for oral, intravenous (IV) or intrathecal (IT) administration,
- wherein optionally the formulation or pharmaceutical composition, or the recombinant, peptidomimetic or a synthetic APOA1BP, or bioisostere of APOA1BP, or nucleic acid encoding the APOA1BP, or vector having contained therein a nucleic acid encoding the APOA1BP, is carried in a nanoparticle, a particle, a micelle or a liposome or lipoplex, a polymersome, a polyplex or a dendrimer, which optionally can further comprise or express a cell or CNS penetrating moiety or peptide or a CNS targeting moiety or peptide;
- or
- (vi) the formulation or pharmaceutical composition of any of (i) to (v), formulated for as a nanoparticle, a liposome, a tablet, a pill, a capsule, a gel, a geltab, a liquid, a powder, an emulsion, a lotion, an aerosol, a spray, a lozenge, an aqueous or a sterile or an injectable solution, or an implant, wherein optionally the implant is an intrathecal implant,
- and wherein the formulation or a therapeutic combination is administered to an individual or patient in need thereof.