DNA-damaging agents such as topoisomerase I inhibitors have taken on added importance as agents that enhance DNA damage response (DDR) defects and inhibitors in tumors. Limitations of camptothecin analogs include their side effects such as myelosuppression and diarrhea, their relatively short half-lives, and the fact that they are substrates of efflux pump proteins. There is thus a need for novel approaches for the use of camptothecin analogs in the treatment of cancers. The present application relates to conjugates of camptothecin analogs comprising a sortilin-targeting peptide and a cleavable linker, and salts thereof. These conjugates were shown to exhibit more potent antitumor effects than corresponding unconjugated camptothecin analogs in a mouse model of Sortilin-expressing colorectal cancer. The present application also relates to pharmaceutical compositions comprising the conjugates or salts thereof, as well as to methods and uses of the conjugates, salts thereof or pharmaceutical compositions for the treatment of Sortilin-expressing cancers.
05 - Pharmaceutical, veterinary and sanitary products
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Pharmaceutical preparations for the treatment of
lipodystrophy, obesity, wasting, growth hormone deficiency,
cognitive impairment and traumatic brain injury.
4.
DRUG CONJUGATE COMPOUNDS FOR STIMULATING THE ANTITUMOR IMMUNE RESPONSE
Despite significant progresses made in the treatment of cancers with the development of immune checkpoint inhibitors (ICI), several cancers exhibit resistance to these agents. Certain tumors are considered immunologically cold tumors usually respond poorly to cancer immunotherapies such as immune checkpoint blockade (ICB) therapy, and thus there is a need to develop novel approaches for the treatment of such cancers. The present application discloses methods and uses for enhancing the anti-tumor immune response in a subject suffering from a Sortilin-expressing cancer and/or treating a subject suffering from a Sortilin-expressing cancer, such as a cancer resistant to an immunotherapy, through the administration of conjugate compounds comprising a Sortilin-targeting agent conjugated to an anticancer agent. Combination therapies comprising the conjugate compounds and an immunotherapy such as ICB are also disclosed.
A61K 47/62 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07D 305/14 - Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms condensed with carbocyclic rings or ring systems
C07K 7/08 - Linear peptides containing only normal peptide links having 12 to 20 amino acids
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
5.
METHODS AND SORTILIN BINDING CONJUGATE COMPOUNDS FOR TARGETING CANCER STEM CELLS
The present application relates to methods and uses of conjugates comprising antitumor agents (e.g., chemotherapeutic agents) conjugated to peptide compounds targeting Sortilin-expressing cancer stem cells (CSCs), in embodiments for the treatment of poor prognosis cancers refractory to standard antitumor therapies associated the presence of Sortilin-expressing CSCs, and for preventing or treating cancer relapse or recurrence.
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
05 - Pharmaceutical, veterinary and sanitary products
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(1) Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury.
7.
LOW-DOSE PHARMACEUTICAL COMPOSITIONS OF GHRH ANALOGS AND USES THEREOF
A pharmaceutical composition comprising a GHRH molecule or a pharmaceutically acceptable salt thereof is described, as well as uses thereof and a kit for preparing such a pharmaceutical composition. In an embodiment, GHRH molecule or pharmaceutically acceptable salt thereof is trans-3-hexenoyl-GHRH(1-44)-NH2 or a pharmaceutically acceptable salt thereof. In an embodiment, a pharmaceutical composition comprising about 1.23 to about 1.32 mg of a GHRH molecule such as trans-3-hexenoyl-GHRH(1-44)-NH2 at a concentration of about 7.5 mg/mL or more, as well as uses thereof and a kit for preparing such a pharmaceutical composition, are described. Uses of such a pharmaceutical composition to obtain plasmatic levels of e.g., trans-3-hexenoyl-GHRH(1-44)-NH2 that are bioequivalent to administration of 2 mg of trans-3-hexenoyl-GHRH(1-44)-NH2 at a concentration of 1 mg/mL in a subject are also described.
The present disclosure relates to compositions comprising a solubilizing agent and a peptide compound and/or a conjugate compound, processes, methods and uses thereof for treatment of cancer or aggressive cancer. For example, the conjugate compounds can comprise the formula of A-(B)n, wherein A is a peptide compound; and B is at least one therapeutic agent, and the peptide compounds can comprise compounds of formula X1X2X3X4X5GVX6AKAGVX7NX8FKSESY (I) (SEQ ID NO: 1) (X9)nGVX10AKAGVX11NX12FKSESY (II) (SEQ ID NO: 2) YKX13LRRX14APRWDX15PLRDPALRX16X17L (III) (SEQ ID NO: 3) YKX18LRR(X19)nPLRDPALRX20X21L (IV) (SEQ ID NO: 4) IKLSGGVQAKAGVINMDKSESM (V) (SEQ ID NO: 5) IKLSGGVQAKAGVINMFKSESY (VI) (SEQ ID NO: 6) IKLSGGVQAKAGVINMFKSESYK (VII) (SEQ ID NO: 7) GVQAKAGVINMFKSES Y (VIII) (SEQ ID NO: 8) GVRAKAGVRNMFKSESY (IX) (SEQ ID NO: 9) GVRAKAGVRN(Nle)FKSESY (X) (SEQ ID NO: 10) YKSLRRKAPRWDAPLRDPALRQLL (XI) (SEQ ID NO: 11) YKSLRRKAPRWDAYLRDPALRQLL (XII) (SEQ ID NO: 12) YKSLRRKAPRWDAYLRDPALRPLL (XIII) (SEQ ID NO: 13) wherein X1 to X21 and n can have various different values and wherein at least one protecting group and/or at least one labelling agent is optionally connected to said peptide compound at an N- and/or C-terminal end.
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 9/00 - Medicinal preparations characterised by special physical form
The present application relates to methods and uses of conjugates comprising antitumor agents (e.g., chemotherapeutic agents) conjugated to peptide compounds targeting Sortilin-expressing cancer stem cells (CSCs), in embodiments for the treatment of poor prognosis cancers refractory to standard antitumor therapies associated the presence of Sortilin-expressing CSCs, and for preventing or treating cancer relapse or recurrence.
A61K 47/66 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid the modifying agent being a pre-targeting system involving a peptide or protein for targeting specific cells
123456789n10111213141516171819n202112121 and n can have various different values and wherein at least one protecting group and/or at least one labelling agent is optionally connected to said peptide compound at an N- and/or C-terminal end.
A61K 47/62 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
A61K 47/66 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid the modifying agent being a pre-targeting system involving a peptide or protein for targeting specific cells
C07K 14/00 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof
C07K 14/195 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury.
05 - Pharmaceutical, veterinary and sanitary products
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS. Providing medical assistance and medical information in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS.
05 - Pharmaceutical, veterinary and sanitary products
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS (1) Providing medical assistance namely instructions on drug administration and assessment of insurance coverage in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS; providing medical information in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS
05 - Pharmaceutical, veterinary and sanitary products
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS Providing medical assistance and medical information in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS
05 - Pharmaceutical, veterinary and sanitary products
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat and liver fat; pharmaceutical preparations for the prevention and treatment of HIV-1 infection; pharmaceutical preparations. Providing medical assistance and medical information in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and HIV-1 infection and related health conditions.
05 - Pharmaceutical, veterinary and sanitary products
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat and liver fat; pharmaceutical preparations for the prevention and treatment of HIV-1 infection Providing medical assistance namely instructions on drug administration in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and treatment of HIV-1 infection; providing medical information in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and HIV-1 infection and related health conditions
05 - Pharmaceutical, veterinary and sanitary products
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat and liver fat; pharmaceutical preparations for the prevention and treatment of HIV-1 infection; (1) Providing medical assistance namely instructions on drug administration and assessment of insurance coverage in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS; providing medical information in the field of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment, traumatic brain injury, visceral adipose tissue, ectopic fat, liver fat and for the treatment of HIV/AIDS" and related health conditions
05 - Pharmaceutical, veterinary and sanitary products
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Pharmaceutical preparations for the treatment of lipodystrophy. (1) Providing medical assistance and medical information in the field of lipodystrophy.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury.
40.
Formulations of growth hormone releasing factor (GRF) molecules with improved stability
A61K 47/48 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
41.
FORMULATIONS OF GROWTH HORMONE RELEASING FACTOR (GRF) MOLECULES WITH IMPROVED STABILITY
Stabilized solid and liquid pharmaceutical formulations comprising a GRF molecule as active ingredient, such as GRF analogs including those comprising an N-terminal-attached hydrophobic moiety, such as [trans-3-hexenoyl]hGHRH (1-44) amide, are disclosed. The formulation comprises a GRF molecule or a pharmaceutically acceptable salt thereof and a β- cyclodextrin which is not conjugated to the GRF molecule or salt thereof. Also disclosed is the use of the formulation for the treatment of various conditions, methods of preparing the formulation, as well as kits containing it. Methods of stabilizing (e.g., with respect to chemical stability) such GRF molecules, as well as methods of inhibiting their deamidation at Asn8, are also disclosed.
Peptide compounds derived from human melanotransferrin, and compositions thereof, are described. Uses of these peptide compounds, for example to modulate angiogenesis and/or cell migration, and/or to treat angiogenesis-related disorders (e.g., cancer), are also described.
Growth Hormone-releasing Factor (GRF) analogs wherein lysine-21, leucine-22 and leucine-23 are deleted are described herein. These analogs retain GRF activity. The uses of said analogs for example as a GRF receptor agonist, e.g. to induce growth hormone secretion in a subject or biological system are also described.
Improved methods for determining normal IGF-1 levels in HIV infected subjects, based on a determination of the log of IGF-1 values obtained in blood-derived samples from a population of HIV-infected subjects, are disclosed. Also disclosed are methods of determining whether a given HIV-infected subject exhibits a normal IGF-1 level, based on a comparison of either the IGF-1 value or the log of the IGF-1 value obtained from a blood-derived sample of the subject with a normative IGF-1 range determined using the exponentiation of the log of IGF-1 values or the log of IGF- values obtained in blood-derived samples from a population of age- and gender-matched HIV- infected subjects. Such methods are useful for example to monitor GH stimulation therapy in HIV- infected subjects.
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
45.
USE OF (HEXENOYL TRANS-3)HGRF(1-44)NH2 AND RITONAVIR IN COMBINATION THERAPY
A combination therapy is described comprising the protease inhibitor Ritonavir and the growth hormone releasing factor (GRF) analogue (hexenoyl trans-3)hGRF(1-44)NH2 (TH9507), for the treatment of HIV- associated lipodystrophy. Human growth hormone may modulate cytochrome P450 (CYP) enzyme activity. Therefore, the potential impact of tesamorelin on CYP3A activity was investigated by examining its effect on the pharmacokinetics (PK) of ritonavir (a CYP3 A-inhibitor), a drug that is potentially administered concomitantly with tesamorelin. This study showed that the impact of tesamorelin on CYP3A activity appears to be minimal. Ritonavir may be co-administered with tesamorelin, without changing the dosing regimen.
A combination therapy is described comprising the CYP-metabolized compound Simvastatin and the growth hormone releasing factor (GRF) analogue (hexenoyl trans-3)hGRF(l-44)NH2 (tesamorelin), for the treatment of HIV- associated lipodystrophy. Human growth hormone may modulate cytochrome P450 (CYP) enzyme activity. Therefore, the potential impact of tesamorelin on CYP3A activity was investigated by examining its effect on the pharmacokinetics (PK) of simvastatin ( a CYP3A-substrate), a drug that is potentially administered concomitantly with tesamorelin. This study showed that the impact of tesamorelin on CYP3 A activity appears to be minimal. Simvastatin may be co-administered with tesamorelin, without changing the dosing regimen.
A61K 38/16 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof
A61K 31/366 - Lactones having six-membered rings, e.g. delta-lactones
C07K 14/60 - Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
C07K 17/02 - Peptides being immobilised on, or in, an organic carrier
A61K 38/27 - Growth hormone [GH], i.e. somatotropin
47.
BIFUNCTIONAL FUSION PROTEINS OF THE ALPHA-MELANOCYTE STIMULATING HORMONE (ALPHA-MSH) AND ATRIAL NATRIURETIC PROTEIN (ANP) AND USES IN HYPERTENSION AND ACUTE KIDNEY INJURY
A bifunctional hormone exhibiting an alpha-MSH activity and a natriuretic peptide activity is described. The bifunctional hormone comprises for example a first domain having alpha-MSH related hormonal activity covalently linked to a second domain having natriuretic peptide related hormonal activity. The bifunctional hormone of the present invention is useful for example for the prevention and/or treatment of renal related diseases or conditions, such as acute renal failure (ARF) or acute kidney injury (AKI).
The invention relates to use of a GH secretagogue (e.g. GRF or an analog thereof) for (1) altering a lipid parameter in a subject; (2) altering a body composition parameter in a subject, (3) treating a condition characterized by deficient or decreased bone formation in a subject (4) improving daytime vigilance and/or cognitive function in a subject, (5) improving a metabolic condition in a subject, (6) improving anabolism in a catabolic condition in a subject, and/or (7) improving and/or reconstituting immune function in a subject.
Stabilized solid and liquid pharmaceutical formulations comprising a GHRH molecules as active ingredient, and more particularly GHRH analogs including [trans-3-hexenoyl]hGHRH (1-44) amide, are disclosed. The formulation comprises an anionic surfactant and a non-reducing sugar, and has a pH of about 4.0 to about 7.5. Also disclosed is the use of the formulation for the treatment of various conditions, methods of preparing the formulation, as well as kits containing it.
05 - Pharmaceutical, veterinary and sanitary products
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Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury; pharmaceutical preparations for the treatment of malnutrition, for the improvement of immune function, and for the improvement of bone mineral density
05 - Pharmaceutical, veterinary and sanitary products
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Pharmaceutical preparations; pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury.
05 - Pharmaceutical, veterinary and sanitary products
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(1) Pharmaceutical preparations for the treatment of lipodystrophy, obesity, wasting, growth hormone deficiency, cognitive impairment and traumatic brain injury.
A pharmaceutical composition comprising a GHRH molecule or a pharmaceutically acceptable salt thereof is described, as well as uses thereof and a kit for preparing such a pharmaceutical composition. In an embodiment, GHRH molecule or pharmaceutically acceptable salt thereof is trans-3-hexenoyl-GHRH(1-44)-NH2 or a pharmaceutically acceptable salt thereof. In an embodiment, a pharmaceutical composition comprising about 1.23 to about 1.32 mg of a GHRH molecule such as trans-3-hexenoyl-GHRH(1-44)-NH2 at a concentration of about 7.5 mg/mL or more, as well as uses thereof and a kit for preparing such a pharmaceutical composition, are described. Uses of such a pharmaceutical composition to obtain plasmatic levels of e.g., trans-3-hexenoyl-GHRH(1-44)-NH2 that are bioequivalent to administration of 2 mg of trans-3-hexenoyl-GHRH(1-44)-NH2 at a concentration of 1 mg/mL in a subject are also described.
The present application relates to methods and uses of conjugates comprising antitumor agents (e.g., chemotherapeutic agents) conjugated to peptide compounds targeting Sortilin-expressing cancer stem cells (CSCs), in embodiments for the treatment of poor prognosis cancers refractory to standard antitumor therapies associated the presence of Sortilin-expressing CSCs, and for preventing or treating cancer relapse or recurrence.
A61K 47/66 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid the modifying agent being a pre-targeting system involving a peptide or protein for targeting specific cells
The invention relates to use of a GH secretagogue (e.g. GRF or an analog thereof) for (1) altering a lipid parameter in a subject; (2) altering a body composition parameter in a subject, (3) treating a condition characterized by deficient or decreased bone formation in a subject (4) improving daytime vigilance and/or cognitive function in a subject, (5) improving a metabolic condition in a subject, (6) improving anabolism in a catabolic condition in a subject, and/or (7) improving and/or reconstituting immune function in a subject.
