Abstract: The present invention relates to crystalline polymorphic forms of the di-sodium salt of N-(5-chlorosalicyloyl)-8-aminocaprylic acid, pharmaceutical compositions containing the same, methods of preparing the same, and methods for facilitating the delivery of active agents with the same.

Abstract: A method for use of a double-structured tissue implant or a secondary scaffold stand alone implant for treatment of tissue defects. The double-structured tissue implant comprising a primary scaffold and a secondary scaffold consisting of a soluble collagen solution in combination with a non-ionic surfactant generated and positioned within the primary scaffold. A method of use of a stand alone secondary scaffold implant or unit for treatment of tissue defects.

Abstract: A sustained-release drug composition consisting essentially of microparticles of hyaluronic acid having a high molecular weight or an inorganic salt thereof and a protein or peptide drug encased in said microparticles, wherein the average size of said microparticles ranges from 0.1 to 40 ?m.

Abstract: The present invention is directed to methods of ameliorating hippocampal dysfunction and improving or inhibiting decline in intelligence or cognitive or hippocampal-dependent memory of a subject and of increasing synthesis and release of neurotransmitters, neurite outgrowth, and levels of neurofilament proteins in the brain and CNS of a subject, comprising administering to the subject a uridine, an acyl derivative thereof, a uridine phosphate, uracil, or a salt thereof.

Abstract: The present invention relates to stable growth hormone (GH) compounds, which through the introduction of cysteine residues have disulphide bridges, which make the compounds resistant to proteolytic degradation.

Abstract: The present invention relates to novel porous matrix composites and formulations for controlled protein delivery and the uses therefor. The present invention also provides methods of synthesizing such protein delivery systems. The composites comprise affinity sites embedded in the matrix where the affinity sites are functionalized with nucleic acid aptamers having high affinity for proteins to be released. The aptamers function as binding affinity sites for the proteins to be released. In certain embodiments, release rates are controlled by tuning the binding affinity of the nucleic acid aptamers to the proteins at a desired level. In yet other embodiments, complementary oligonucleotides that hybridize with the aptamers are employed to trigger accelerated release of the proteins when desired. Various in situ injectable hydro gels functionalized with aptamers are provided for treating a condition and disease in a subject in need of a therapeutic protein.

Abstract: The instant disclosure relates to a wound dressing, which includes a plurality of hydrogel particles and a dressing. The hydrogel particles are granular colloids capable of absorbing and releasing the fluid, and the hydrogel particles are disposed to fill up the wound entirely. The dressing is covered on the wound to seal the hydrogel particles inside the wound. Thus, the wound dressing can maintain the appropriate balance of moisture in the wound environment to promote healing.

Abstract: The invention relates to 3-[4-(phenylaminooxalylamino)phenyl]hex-4-ynoic acids, and to physiologically compatible salts thereof. The invention relates to compounds of the formula I in which R1, R2, R3 and R4 are each defined as specified, and to physiologically compatible salts thereof. The compounds are suitable, for example, for treatment of diabetes.

Abstract: The present invention relates to the use of genetic markers to identify the response to growth hormone treatment in Growth Hormone Deficiency (GHD) or Turner Syndrome (TS) patients as well as a method of treating GHD or TS patients and kits for genotyping.

Abstract: The present invention relates to growth hormone conjugates comprising a bile acid residue, said conjugation may occur through wt or mutant amino acid residues. The growth hormone polypeptide may be wt human growth hormone or a growth hormone variant.

Abstract: The application relates to a composition comprising a hyperbranched polymer attached to a core and a biologically active moiety. The biologically active moiety is attached to the core by means of a substantially non-enzymatically cleavable linker L. The composition can be used to deliver the biologically active moiety to its target.

Abstract: The present invention provides novel conformationally-defined macrocyclic compounds that have been demonstrated to be selective modulators of the ghrelin receptor (growth hormone secretagogue receptor, GHS-R1a and subtypes, isoforms and variants thereof). Methods of synthesizing the novel compounds are also described herein. These compounds are useful as agonists of the ghrelin receptor and as medicaments for treatment and prevention of a range of medical conditions including, but not limited to, metabolic and/or endocrine disorders, gastrointestinal disorders, cardiovascular disorders, obesity and obesity-associated disorders, central nervous system disorders, genetic disorders, hyperproliferative disorders and inflammatory disorders.

Abstract: Methods are disclosed for treating sepsis and septic shock using a combination of ghrelin and growth hormone, and for using ghrelin to reduce organ and tissue injury and improve survival after combined radiation exposure and sepsis.

Abstract: The present invention relates to pharmaceutical compositions containing at least one protein active ingredient protected from digestive enzymes. Said pharmaceutical compositions contain said at least one protein active ingredient, in free form, as well as, for liquids, a system that buffers them to a pH greater than 4 and less than or equal to 8 or, for solids, a system that exerts, when they are placed a liquid medium, a buffer effect between a pH greater than 4 and a pH less than or equal to 8.

Abstract: A method for alleviating a symptom of chemotherapy in a subject comprises identifying a subject undergoing chemotherapy and then administering a therapeutically effective amount of a GH/IGF-1 Axis inhibitory composition to the subject. Typically, the levels of IGF-1 and/or GH in the subject are monitored as well as chemotherapy related symptoms. A method of alleviating oxidative damage, cellular damage including mutations, and insulin resistance in a subject is also provided.

Abstract: Disclosed herein are compositions and methods useful for the treatment of cancer, such as breast cancer. In some embodiments, the methods and compositions include human prolactin, or human prolactin in conjunction with a cytotoxic agent. In other embodiments, the methods and compositions include one or more of human prolactin, growth hormone and placental lactogen, or one or more of human prolactin, growth hormone and placental lactogen in conjunction with a cytotoxic agent. In some embodiments, the cytotoxic agent comprises a chemotherapeutic agent.

Abstract: Non-natural amino acids and polypeptides that include at least one non-natural amino acid, and methods for making such non-natural amino acids and polypeptides, are disclosed. The non-natural amino acids, by themselves or as a part of a polypeptide, can include at least one oxime, carbonyl, dicarbonyl, and/or hydroxylamine group. Methods for making, modifying, and purifying the non-natural amino acid polypeptides are also disclosed. Further, methods for using such non-natural amino acid polypeptides and modified non-natural amino acid polypeptides, including therapeutic, diagnostic, and other biotechnology uses, are disclosed.

Abstract: We disclose growth hormone [GH] fusion proteins that have increased in vivo stability and activity; nucleic acid molecules encoding said proteins and methods of treatment of growth hormone deficiency that use said fusion proteins. The GH fusion proteins comprise human GH covalently linked to the extracellular domain of Growth Hormone Receptor [GHR] either as a direct in-frame translational fusion or via a flexible peptide linker. The GH/GHR fusion proteins have exceptional pharmacokinetics and are potent growth hormone receptor agonists. The GH/GHR fusion proteins form head to tail dimers.

Abstract: The present invention provides methods and materials by which glycosylation of glycoproteins can be regulated. Methods include the monitoring and regulation of parameters such that a glycoprotein having a desired product quality is obtained.

Abstract: The present invention provides a method of increasing neural stem cell numbers or neurogenesis by using prolactin. The method can be practiced in vivo to obtain more neural stem cells in situ, which can in turn produce more neurons or glial cells to compensate for lost or dysfunctional neural cells. The method can also be practiced in vitro to produce a large number of neural stem cells in culture. The cultured stem cells can be used, for example, for transplantation treatment of patients or animals suffering from neurodegenerative diseases or conditions. In addition, since neural stem cells are a source for olfactory neurons, the present invention also provides methods of increasing olfactory neurons and enhancing olfactory functions.

Abstract: Disclosed is a preparation for transnasal application, which has improved fluidability. Specifically disclosed is a preparation for transnasal application, which comprises at least a complex comprising: a fluidability-improving component comprising a first crystalline cellulose (A) having specified powder properties, tricalcium phosphate (B) having specified powder properties, and a second crystalline cellulose (C) having specified powder properties or a starch (D) having specified powder properties; and a physiologically active substance.

Abstract: We describe modified growth hormone fusion proteins and dimers comprising said fusion proteins; nucleic acid molecules encoding said proteins and methods of treatment that use said proteins in the treatment of conditions that result from growth hormone excess.

Abstract: There is disclosed a composition formed by a reaction of at least one component A and at least one component B, wherein component A is selected from the group consisting of a compound comprising at least two thiol-groups and a disulfide derivative of a compound comprising at least two thiol groups, and wherein component B is a compound comprising at least two vinyl groups, for the manufacture of an implant for the treatment of a bone fracture. Advantages include that the adhesive patch formed by the composition will be solid in body fluid upon curing and will exhibit excellent mechanical strength. Advantages include that the composition is biocompatible, the material can be applied in small and inaccessible areas, the process requires less surgeon training, it solves drawback with open surgery, and it is possible to use cost effective materials and methods in the process.

Abstract: The disclosure relates to treating muscle wasting-associated disorders in a patient, using a therapeutically effective amount of an antagonist of Fbxo40, wherein the antagonist reduces the expression, level or activity of Fbxo40. The Fbxo40 antagonist increases muscle mass, or prevents, limits or reduces muscle mass loss, in the patient. The Fbxo40 antagonist can be a low molecular weight (LMW) compound, a protein, an antibody, or an inhibitory nucleic acid, such as a siRNA. The disclosure also relates to methods of screening for antagonists of Fbxo40, and methods of diagnosing or monitoring levels of muscle mass maintenance, loss or increase.

Abstract: The invention provides a pharmaceutical composition comprising a mixture of: (a) an active macromolecular principle; and (b) a non-conjugated bile acid or salt; and (c) an additive chosen from propyl gallate, butyl hydroxy anisole (BHA) and analogues and derivatives thereof, or mixtures thereof.

Abstract: A use of an inhalable powder formulation for preventing or treating an NMDA receptor hypofunction-related disease, a method for preventing or treating an NMDA receptor hypofunction-related disease in a subject, which comprises administering a therapeutically effective amount of an inhalable powder formulation comprising growth hormone (GH) to the subject in need thereof, and an inhalable powder formulation for preventing or treating an NMDA receptor hypofunction-related disease comprising GH as an active ingredient are provided.

Abstract: Methods and compositions for the use of long-acting hematopoietic factor protein analogs for accelerating hematopoietic recovery in subjects who have been or will be exposed to radiation are disclosed.

Abstract: Modified bovine somatotropin polypeptides and uses thereof are provided.

Abstract: Modified porcine somatotropin polypeptides and uses thereof are provided.

Abstract: A polypeptide and polynucleotides encoding same comprising one carboxy-terminal peptide (CTP) of chorionic gonadotrophin attached to an amino terminus of a growth hormone and two carboxy-terminal peptides (CTP) of chorionic gonadotrophin attached to a carboxy terminus of a growth hormone are disclosed. Pharmaceutical compositions comprising the polypeptide and polynucleotides of the invention and methods of using same are also disclosed.

Abstract: Pharmaceutical compositions comprising pegylated growth hormone at pH 7 or below are provided.

Abstract: It is provided a pharmaceutical composition stably containing ghrelin or its derivative, which is an endogenous growth hormone secretagogue (GHS) to a growth hormone secretagogue-receptor (GHS-R), comprising a aqueous solution containing the ghrelins having pH range of 2 to 7, wherein the aqueous solution having pH range of 2 to 7 is a buffer solution, especially, glycine hydrochloride buffer, acetate buffer, citrate buffer, lactate buffer, phosphate buffer, citric acid-phosphate buffer, phosphate-acetate-borate buffer or phthalate buffer, and the concentration of the ghrelins in the solution is from 0.03 nmol/mL to 6 ?mol/mL.

Abstract: The invention discloses particulate complexes composed of chitosan, poly-glutamic acid, and at least one bioactive agent, wherein equal moles of the positively charged chitosan and the negatively charged poly-glutamic acid substrate form an electrostatic network enabling improved loading the bioactive agent.

Abstract: The invention relates to biopolymer-gel based depot systems for prolonged and/or controlled release delivery of biologically active agents, methods for the manufacture of the biopolymer based gel-depots which include a biologically active agent, and uses of such biopolymer gel-depots in therapy. The biopolymer-gel based depot systems comprise a biocompatible polyaminosaccharide and/or protein; a biocompatible phosphate and/or sulphonamide compound; a biologically active agent; an aqueous insoluble alkaline earth metal phosphate; and a biocompatible glycan and/or proteoglycan.

Abstract: This invention relates to a conjugate of a polymer moiety and an interferon-? moiety, an erythropoietin moiety, or a growth hormone moiety.

Abstract: We describe modified growth hormone fusion proteins and dimers comprising said fusion proteins; nucleic acid molecules encoding said proteins and methods of treatment that use said proteins in the treatment of conditions that result from growth hormone excess.

Abstract: Methods and assays are disclosed for treating subjects with 22q13 deletion syndrome or SHANK3 deletion or duplication, mutation or reduced expression, where the methods comprise administering to the subject insulin-like growth factor 1 (IGF-1), IGF-1-derived peptide or analog, growth hormone, an AMPAkine, a compound that directly or indirectly enhances glutamate neurotransmission, including by inhibiting inhibitory (most typically GABA) transmission, or an agent that activates the growth hormone receptor or the insulin-like growth factor 1 (IGF-1) receptor, or a downstream signaling pathway thereof

Abstract: The present invention relates to polypeptide compound optimized for subcutaneous administration, exemplified by growth hormone conjugates having a linker providing non-covalent binding to albumin.

Abstract: Disclosed herein are an in situ-forming, bioadhesive hydrogel and the medical uses thereof. Being formed by in situ crosslinking through an enzymatic reaction, the hydrogel has an advantage over conventional bioadhesive hydrogels in terms of biocompatibility. In addition, the in situ-forming bioadhesive hydrogel has excellent biocompatibility and mechanical strength and has excellent tissue adhesiveness thanks to modification with/without dopa derivatives. The hydrogel finds a variety of applications in the biomedical field, including bioadhesives or hemostats, implant substances for tissue regeneration and augmentation, carriers for delivering biologically active materials or drugs, etc.

Abstract: The present invention relates to methods of predicting the level of response to treatment with growth hormone in an individual having Growth Hormone Deficiency (GHD) or Turner Syndrome (TS).

Abstract: The present invention provides novel calcium phosphate nanoparticles suitable for efficient encapsulation of biologically active molecules. The invention further provides pharmaceutical compositions comprising these nanoparticles, as well as methods of making such nanoparticles and using them as carriers for therapeutic delivery of biologically active macromolecules.

Abstract: The invention relates to a method of co-administering a peptide or protein drug with an enzyme-resistant PGA-complexone compound orally so to mitigate enzyme attack in the gastrointestinal tract of an animal subject.

Abstract: Disclosed are in situ-forming injectable hydrogel and medical uses thereof. In the in situ-forming injectable hydrogel two or more homogeneous or heterogeneous polymers are bonded to each other by a dehydrogenation reaction between phenol or aniline moieties on adjacent polymers, wherein a polymer backbone is grafted with a phenol or aniline moiety using a linker. In contrast to conventional hydrogel, the in situ-forming injectable hydrogel is superior in terms of in vivo stability and mechanical strength thanks to the introduction of a water-soluble polymer as a linker which leads to an improvement in the reactivity of phenol or aniline moieties. Having the advantage of superior bio stability and mechanical strength, the hydrogel finds a variety of applications in the biomedical field.

Abstract: The present invention relates biomedically useful compositions containing bioactive agents and biodegradable carbohydrate polyethers that exhibit reverse thermogelation properties in aqueous media. The microstructure structure and properties of the carbohydrate polyethers can be conveniently controlled with respect to functionality, molecular weight, polydispersity index, microstructure and tertiary structure, they can be customized for use in a variety of biomedical applications including drug delivery, cell delivery, surgical procedures and the like.

Abstract: Methods of treating a lysosomal storage disorder and methods of increasing cellular uptake of a lysosomal enzyme using ?2 agonists or therapeutic agents that increase expression of receptors for a lysosomal enzyme.

Abstract: The present invention is directed generally to recombinant methods for making a desired polypeptide. These method(s) yield a polypeptide product containing reduced levels of isoform impurities thereof. In particular, the present invention is directed to (1) a recombinant method for preparing growth hormone with reduced isoform impurities thereof and (2) a recombinant method for preparing a growth hormone antagonist, such as pegvisomant, and its protein intermediate, also having reduced isoform impurities thereof. More specifically, the isoform impurities that are decreased by methods of the present invention are the trisulfide and des-phe isoform impurities of growth hormone and growth hormone antagonist (or its intermediate), respectively.

Abstract: The present invention relates to a method of stimulating the motility of the gastrointestinal system in a subject in need thereof, wherein the subject suffers from maladies (i.e., disorders or diseases) of the gastrointestinal system. The method comprises administering to a subject in need thereof a therapeutically effective amount of a growth hormone secretagogue compound or a pharmaceutically acceptable salt, hydrate or solvate thereof. The growth hormone secretagogue can be co-administered with a laxative, a H2 receptor antagonist, a serotonin 5-HT4 agonist, an antacid, an opioid antagonist, a proton pump inhibitor, a motilin receptor agonist, dopamine antagonist, a cholinergic agonist, a cholinesterase inhibitor, somatostatin, octreotide, or any combination thereof.

Abstract: Modified growth hormone polypeptide and uses thereof are provided.

Abstract: A formulation delivery system is disclosed. When configured as a pro-liposome oral tablet, the tablet comprises a blend of at least one Iiposome forming ingredient, at least one active ingredient and at least one co-disintegrant. After ingestion at least a portion of the tablet disintegrates in a portion of an alimentary system to provide one or more in situ Iiposome encapsulated active ingredients. A method of producing the pro-liposome oral tablet and a method of therapeutically dosing with the pro-liposome oral tablet are further disclosed. The formulation delivery system may be configured as any one of a pro-liposome oral tablet, sublingual tablet, caplet, capsule and aerosol.

Abstract: The present invention relates to crystalline polymorphic forms of the di-sodium salt of N-(5-chlorosalicyloyl)-8-aminocaprylic acid, pharmaceutical compositions containing the same, methods of preparing the same, and methods for facilitating the delivery of active agents with the same.