Abstract: Provided are methods relating to the use of CDP-therapeutic agent conjugates for the treatment of a disease or disorder, e.g., autoimmune disease, inflammatory disease, central nervous system disorder, cardiovascular disease, or metabolic disorder. Also provided are CDP-therapeutic agent conjugates, particles comprising CDP-therapeutic agent conjugates, and compositions comprising CDP-therapeutic agent conjugates.

Abstract: Peptide fragments having amino acid sequences corresponding to portions of a thymosin beta 4, a thymosin beta 10 and/or a thymosin beta 15 amino acid sequence are provided, as well as methods of treatment utilizing same.

Abstract: A method of treating or preventing cognitive impairment deficits in subjects with age-associated cognitive decline or a dementing illness includes administering to the subject a therapeutically effective amount of amylin, an amylin agonist, or an amylin derivative to treat the cognitive impairment or deficit.

Abstract: A method for aiding in categorising or determining prognosis in a patient with cancer, for example breast cancer (or, for example, hepatocellular, bladder or gastric cancer) or in selecting a therapeutic strategy for a patient with cancer, for example breast cancer (or, for example, hepatocellular, bladder or gastric cancer), the method comprising the step of assessing the level of LMTK3 nucleic acid, protein or activity in a sample obtained from the patient and/or assessing the patient's genotype for LMTK3, optionally at position rs8108419 (in intron 2 of the LMTK3 gene) and/or position rs9989661 (in intron 15 of the LMTK3 gene). The method may further comprise the step of assessing the level of ERa nucleic acid, protein or activity in a sample obtained from the patient, particularly in the case of breast cancer.

Abstract: Biodegradable polymeric microparticle compositions containing one or more active agents, especially those useful for treating or preventing one or more diseases or disorders of the eye, and methods of making and using thereof, are described. In a preferred embodiment, the microparticle compositions contain one or more active agents useful for managing elevated intraocular pressure (IOP) in the eye. Relatively hydrophilic, and preferably carboxylated, polymeric materials such as PLGA are used for a drug such as timolol maleate, which is relatively water soluble, to increase drug loading. Higher molecular weight polymers, as well as the ratio of LA (which has a longer degradation time, up to one to two years) to GA (which has a short degradation time, as short as a few days to a week), are used to provide release over a longer period of time.

Abstract: Methods and compositions for treating psychiatric diseases and disorders are disclosed. The methods provided generally involve the administration of an amylin or an amylin agonist to a subject in order to treat psychiatric diseases and disorders, and conditions associated with psychiatric diseases and disorders.

Abstract: The present invention is related to the peptide Des-[Asp1]-[Ala1]-Angiotensin-(1-7) (Ala1-Arg2-Val3-Tyr4-Ile5-His6-Pro7) and/or its related compounds as vasodilating and cardioprotective agents to be used in mammals. This invention also comprises the production of compositions containing Des-[Asp1]-[Ala1]-Angiotensin-(1-7) and/or its related compounds and its use in methods for treating and preventing diseases.

Abstract: The present invention is embodied by a composition capable of chaperoning a typically non-orally available therapeutic or diagnostic agent through the environment of the digestive tract such that the therapetuic or diagnostic agent is bioavailable. The composition may or may not be targeted to specific cellular receptors, such as hepatocytes. Therapeutic agents include, but are not limited to, insulin, calcitonin, serotonin, and other proteins. Targeting is accomplished with biotin or metal based targeting agents.

Abstract: A method for locally controlled release of an effective amount of PTH(1-34) by a hyaluronic acid based hydrogel that can injected intra-articularly for the treatment of osteoarthritis is provided.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: Polypeptides and polynucleotides encoding same comprising at least one carboxy-terminal peptide (CTP) of chorionic gonadotrophin attached to a carboxy terminus of a coagulation factor and not to an amino terminus are disclosed. Pharmaceutical compositions comprising the polypeptides and polynucleotides of the invention and methods of using same are also disclosed.

Abstract: A spray-drying apparatus includes a drying chamber that has a first end, a second end, and at least one side wall extending between the first and second ends to define an interior of the drying chamber having a center axis. A nozzle can be positioned at the first end of the drying chamber and be configured to atomize liquid and spray the atomized liquid into the interior of the drying chamber at a maximum spray pattern angle relative to the center axis. A heating device can be provided to heat the liquid prior to introduction into the drying chamber.

Abstract: Polymer and drug containing compositions and method of preparing such compositions are disclosed. The dispersed phase formulation has a polymer, a pharmaceutically or biologically active agent and a small fraction of low pKa acid additive. Stable, filter sterilizable, non-gelling solutions containing GnRH analogues at least at levels typically used in sustained release formulations and a method of increasing solubility of a high level of a GnRH analogue or a freeze-dried antgonist of GnRH in a polymer containing solution are also disclosed. The amount of the acid additive in the polymer solution is such that it is sufficient to increase the solubility of the high level of the GnRH analogue in the polymer solution without affecting the release characteristics of the microspheres prepared therefrom.

Abstract: Compositions and methods for inducing the deposition of elastin in skin by administering compositions including a mineralocorticoid, such as, for example, aldosterone and, optionally, a secondary active agent for enhancing or modulating the effect of the mineralocorticoid are described herein.

Abstract: The present invention was accomplished for the purpose of developing a method for effectively treating and/or preventing synucleinopathies, and is based on a discovery that an adiponectin receptor agonist suppresses ? (alpha)-synuclein aggregation, tau phosphorylation and a decrease in proteasomal activity. The method of the present invention for treating and/or preventing neurodegenerative diseases includes a step of administering an effective dose of at least one effective element selected from a group consisting of: adiponectin as an adiponectin receptor agonist; a compound inducing expression of adiponectin; globular adiponectin; and a compound inducing expression of globular adiponectin. The present invention further provides a screening method of the adiponectin receptor agonist for treating and/or preventing neurodegenerative diseases.

Abstract: A method and a composition for decreasing ghrelin levels and/or decreasing ghrelin/unacylated ghrelin ratio in a subject, the method comprising administering an effective amount of unacylated ghrelin, a fragment thereof, an analog thereof and/or pharmaceutically acceptable salts thereof to the subject wherein a reduction in ghrelin levels and/or a reduction in ghrelin/unacylated ghrelin ratio is beneficial to the subject. Also, use of ghrelin level and/or ghrelin/unacylated ghrelin ratio as biomarkers for determining a subject's likelihood of responding to and/or benefiting from administration of unacylated ghrelin.

Abstract: Provided are a means for the prevention and treatment of obesity and/or insulin resistance and, particularly, pharmaceutical drugs for the treatment of obesity and/or insulin resistance under the influence of FSTL3. Specifically, provided is an insulin resistance improving drug comprising an FSTL3 inhibitor as an active ingredient, particularly, the insulin resistance improving drug, wherein the FSTL3 inhibitor is one of (A) a substance specifically binding to FSTL3 to inhibit or suppress a function of FSTL3, (B) an inhibitor for expression of FSTL3, and (C) a competitor of FSTL3.

Abstract: The present invention encompasses methods, compositions, and devices for treating an ocular disease, disorder or condition in a mammal. The invention includes polypeptides that possess anti-inflammatory, anti-apoptotic, immune modulatory and anti-tumorigenic properties, and their application in the treatment of eye disease, particularly diseases of the retina. In particular aspects, the invention includes administration of a therapeutic polypeptide such as a stanniocalcin family member protein for the treatment of an eye disease. Also included are fusion proteins and cells stimulated or modified to express the therapeutic polypeptides as set forth herein.

Abstract: The present invention relates generally to novel GIP analogs and GIP hybrid polypeptides with selectable properties, useful as agents for the treatment and prevention of metabolic diseases and disorders, for example those which can be alleviated by control plasma glucose levels, insulin levels, and/or insulin secretion, positive inotropic effects, reduction of catabolic effects, slowing of gastric emptying. Such conditions and disorders include, but are not limited to, hypertension, dyslipidemia, cardiovascular disease, eating disorders, critical care, insulin-resistance, obesity, and diabetes mellitus of any kind, including type 1, type 2, and gestational diabetes.

Abstract: A hair regrowth system consisting of sensitization, growth, and maintenance kits for alopecia areata and related alopecia balding conditions. Graduated doses of specific engineered and or extracted haptens are included in a sensitization kit for initiating immune system response in hairless areas. A growth kit containing topical hormones to increase papilla size and vigor and a maintenance kit to sustain immune system response and papilla size and vigor for the long term are included in some embodiments.

Abstract: The present invention provides optical agents comprising optically functional cross linked supramolecular structures and assemblies useful for tandem optical imaging and therapy. Supramolecular structures and assemblies of the present invention include optically functional shell-cross linked micelles wherein optical functionality is achieved via incorporation of one or more linking groups that include one or more photoactive moieties. The present invention further includes imaging and therapeutic methods using one or more optical agents of the present invention including optically functional shell cross-linked micelles having an associated therapeutic agent.

Abstract: This invention relates to tryptophan hydroxylase inhibitors, compositions comprising them, and methods of their use for the treatment, management and/or prevention of metastatic bone disease.

Abstract: A method for manufacturing a drug-delivery composition includes providing at least one pharmaceutically active compound, a dry powder comprising at least a polymer, and an aqueous solution. The dry powder, the pharmaceutically active compound and the aqueous solution are mixed to form a paste-like or semi-solid drug-delivery composition, wherein the aqueous solution is added in an amount of less than or equal to twice the total dry mass of the dry powder.

Abstract: A method of introducing a physiologically-active agent into the circulatory system of a mammal is disclosed herein. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent being administered to a patient in need of treatment. In particular, the drug delivery system is designed for pulmonary drug delivery such as by inhalation, for delivery of the active agents such as proteins and peptides to the pulmonary circulation in a therapeutically effective manner avoiding degradation of the active agents in peripheral and vascular tissue before reaching the target site.

Abstract: A novel use of a neuropeptide for treating brain injury in a subject in need thereof is provided. The present invention also provides various amenable routes of administering urocortin, that is, via injection intracerebroventricularly and intraperitoneally, and via intravenous bolus administration.

Abstract: The present invention provides a method of increasing neural stem cell numbers or neurogenesis by using a pheromone, a luteinizing hormone (LH) and/or a human chorionic gonadotrophin (hCG). 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 or suspected of having neurodegenerative diseases or conditions.

Abstract: The present invention relates to PYY derivatives comprising a serum albumin binding side chain, wherein said derivative has a half-life of at least 7 hours as determined by Assay (IV) described herein as well as compositions comprising said derivative and its use in therapy.

Abstract: The invention provides novel pyrimidine derivatives of formula I, to methods of preparing such compounds, to pharmaceutical compositions containing such compounds, and to methods for using such compounds in treatment of diseases including cancer; wherein R1, R2, R3, R4, R5, L, A, D, E, Z, and Y are as defined in the specification.

Abstract: A method is disclosed which is useful for elevating blood thyroid hormone levels in avian species (especially poultry species such as chickens, turkeys, ducks, quail, etc.) by implantation, injection, or supplementation of feed or water with thyroid hormones or thyroid-active substances (e.g., L-thyroxine, triiodothyronine, defatted and dessicated thyroid) to induce molting in order to extend egg production.

Abstract: The present invention provides Oxyntomodulin peptide analogues useful in the treatment of diabetes and/or obesity.

Abstract: The present invention provides therapeutic agents and compositions comprising elastin-like peptides (ELPs) and therapeutic proteins. In some embodiments, the therapeutic protein is a GLP-1 receptor agonist, insulin, or Factor VII/VIIa, including functional analogs. The present invention further provides encoding polynucleotides, as well as methods of making and using the therapeutic agents. The therapeutic agents have improvements in relation to their use as therapeutics, including, inter alia, one or more of half-life, clearance and/or persistance in the body, solubility, and bioavailability.

Abstract: The present invention includes methods and compositions related to diagnosis of bladder cancer, including the presence of bladder cancer and/or the type or stage of bladder cancer. In specific embodiments, the expression of one, two, three, four, five, or more miRNAs of the invention are associated with detection of bladder cancer, typing of bladder cancer, or staging of bladder cancer. Kits and microarrays are encompassed in the invention.

Abstract: A composition for reconstruction, replacement or repair of damaged or diseased biological tissue comprising an extracellular matrix (ECM) composition that includes an ECM scaffold component derived from a mammalian source and at least one additional bioactive component selected from the group consisting of a statin and a chitin derivative.

Abstract: The invention relates to polypeptides comprising an amino acid sequence which is an analogue of pramlintide, pharmaceutical compositions comprising these polypeptides, and these polypeptides for use as medicaments.

Abstract: The present invention provides particular anti-inflammatory factors, compositions containing them, methods of making, identifying, and/or characterizing them, and methods of using them. In some embodiments, provided factors are expressed by human bone marrow stromal cells (MSC). In some embodiments, provided factors are characterized by an ability, when contacted with mammalian leukocytes in culture, to alter production of at least one inflammatory or anti-inflammatory agent by the mammalian leukocytes. In some embodiments, provided factors include GALNT1 polypeptides, LGALS3BP polypeptides, MFAP5 polypeptides, PENK polypeptides and/or HAPLN1 polypeptides. In some embodiments, provided factors are useful in the inhibition of inflammatory agents, in the promotion of anti-inflammatory agents, and/or for the treatment of subjects suffering from or susceptible to a disease, disorder or condition characterized by inflammation.

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: A method of introducing a physiologically-active agent into the circulatory system of a mammal is disclosed herein. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent being administered to a patient in need of treatment. In particular, the drug delivery system is designed for pulmonary drug delivery such as by inhalation, for delivery of the active agents such as proteins and peptides to the pulmonary circulation in a therapeutically effective manner avoiding degradation of the active agents in peripheral and vascular tissue before reaching the target site.

Abstract: A chimeric therapeutic polypeptide of a pre-existing therapeutic polypeptide is disclosed, as are a method of enhancing folded stabilization and a pharmaceutical composition of the glycosylated chimer. The pre-existing and chimeric polypeptides have substantially the same length, substantially the same amino acid residue sequence, and exhibit at least one tight turn containing a sequence of four to about seven amino acid residues in which at least two amino acid side chains extend on the same side of the tight turn and are within less than about 7 ? of each other. The chimeric therapeutic polypeptide has the sequon Aro-(Xxx)n-(Zzz)p-Asn-Yyy-Thr/Ser (SEQ ID NO:001) within that tight turn sequence such that the side chains of the Aro, Asn and Thr/Ser amino acid residues project on the same side of the turn and are within less than about 7 ? of each other. That sequon is absent from the pre-existing therapeutic polypeptide.

Abstract: In certain aspects, the present invention provides compositions and methods for decreasing FSH levels in a patient. The patient may, for example, be diagnosed with an FSH-related disorder or desire to delay or inhibit germ cell maturation.

Abstract: Embodiments of the invention are directed to methods for predicting the resistance of cancer to members of the taxoid family by measuring the levels of prohibitin. Methods for treating cancer and taxoid family member resistant cancers using inhibitors of prohibitin, as well as therapeutic complexes that target prohibitin are also provided.

Abstract: The invention provides methods and dosing regimens for safely and effectively treating androgen-dependent prostate cancer with a gonadotrophin releasing hormone (GnRH) antagonist without causing a testosterone spike and/or other side effect of GnRH agonist therapy such as a urinary tract infection, or an arthralgia-related or cardiovascular side effect. The present disclosure also provides for methods for treating prostate cancer in a patient with a history of at least one cardiovascular event, wherein administration of degarelix to the subject decreases the likelihood of developing or experiencing an additional cardiovascular event compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist.

Abstract: Novel GRF analogs having GRF activity are described herein, as well as uses thereof for example as a GRF receptor agonist, e.g., to induce growth hormone secretion in a subject or biological system.

Abstract: Methods and compositions are disclosed to treat metabolic disorders such as obesity, diabetes, and increased cardiovascular risk comprising administering a therapeutically effective amount of a PYY or a PYY agonist.

Abstract: Peptide analogues of PYY, compositions comprising said analogues and methods of using said analogues for the treatment and prevention of metabolic disorders, for example disorders of energy metabolism such as diabetes and obesity, and for a reduction in appetite, reduction in food intake or reduction of calorie intake in a subject.

Abstract: The invention relates to polypeptides comprising an amino acid sequence which is an analogue of pramlintide, pharmaceutical compositions comprising these polypeptides, and these polypeptides for use as medicaments.

Abstract: The invention provides a powdered composition for nasal administration, comprising a physiologically active peptide and cellulose acetate as the base, and having excellent nasal absorption for physiologically active peptides.

Abstract: A composition comprising doxepin, or a pharmaceutically acceptable salt, or prodrug thereof, and a compound that enhances sleep onset, sleep maintenance or reduces early morning awakenings. These compositions are useful for treating multiple manifestations of insomnia.

Abstract: An object of the present invention is to provide a therapeutic agent for accelerating recovery to accelerate a return to normal physical conditions by administering to an animal not in good health and under medical treatment, a treatment method, and the like. There is provided a therapeutic agent for accelerating recovery for animal use to accelerate the improvement of a physical condition of an animal under medical treatment which has a decreased activity (vigor) and is exhausted, which contains ghrelin or a derivative thereof or a pharmaceutically acceptable salt thereof as an active ingredient and improves one or more of evaluation parameters consisting of activity (vigor), blood cell test values, biochemical test values, body temperature, the degree of anger or anxiety, and respiratory rate.

Abstract: The invention relates to polypeptides comprising an amino acid sequence which is an analogue of pramlintide, pharmaceutical compositions comprising these polypeptides, and these polypeptides for use as medicaments.

Abstract: The present invention provides for a method for stimulating the proliferation of pluripotential stem cells in a mammal comprising administration of pregnancy related compounds more particularly human chorionic gonadotropin, leutenizing hormone or prolactin. The present invention further provides for a method of treatment of tissues or organs experiencing cellular damage, injury or disease.