Abstract: The present invention relates to a solid or semi-solid pharmaceutical composition that includes a polypeptide drug, at least one polar organic solvent, at least one surfactant, at least one hydrophilic component and which composition is spontaneously dispersible.

Abstract: Methods and compositions for treating cancer are described herein. More particularly, the methods for treating cancer comprise administering a 17?-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3?-acetoxy-17-(3-pyridyl) androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. Furthermore, disclosed are compositions comprising a 17?-hydroxylase/C17,20-lyase inhibitor, and at least one additional therapeutic agent, such as an anti-cancer agent or a steroid.

Abstract: This disclosure provides peptides, polypeptides, fusion polypeptides, compositions, and methods for enhancing or increasing the stability of a polypeptide (e.g., Taq polymerase). Such peptides, polypeptides, fusion polypeptides, or compositions include polypeptides linked to a peptide tag that enhances the stability of the polypeptide. The peptides, polypeptides, fusion polypeptides, compositions may also enhance the activity, specificity, and/or fidelity of other polypeptides in a reaction mixture. The disclosure also provides methods of using such peptides, polypeptides, fusion polypeptides, compositions.

Abstract: The invention provides a pharmaceutical composition for oral drug delivery comprising a solid dosage form containing an effective amount of a therapeutic agent, a permeation enhancer and a pharmaceutically acceptable excipient and a bioadhesive layer containing a bioadhesive polymer, and optionally comprising an impermeable or semi-permeable layer having an opening capable of directing a unidirectional release of the therapeutic agent and the permeation enhancer from the solid dosage form. Methods of making and using the present pharmaceutical composition are also provided.

Abstract: There is provided a novel series of analogues of glucose-dependent insulinotropic polypeptide compounds, pharmaceutical compositions containing said compounds, and the use of said compounds as GIP-receptor agonists or antagonists for treatment of GIP-receptor mediated conditions, such as non-insulin dependent diabetes mellitus and obesity.

Abstract: The present invention relates to methods of treating polycystic ovary syndrome (PCOS) comprising administering glucagon-like peptide-1 (GLP-1), exendin, and analogs and agonists thereof, to subjects suffering therefrom.

Abstract: SRIF peptide antagonists, which are selective for SSTR2 in contrast to the other cloned SRIF receptors and which bind with high affinity to the cloned human receptor SSTR2 but do not activate the receptor, have many useful functions. Because they do not bind with significant affinity to SSTR1, SSTR3, SSTR4 or SSTR5, their administration avoids potential undesirable side effects. Because they block the receptor function, they can be used therapeutically to block certain physiological effects which SSTR2 mediates. By incorporating radioiodine or the like in these SSTR2-selective SRIF antagonists, a labeled compound useful in drug-screening methods is provided. Alternatively, for use in therapy, highly radioactive moieties can be N-terminally coupled, complexed or chelated thereto.

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: A transmembrane fusion protein including ubiquitin or a ubiquitin-like protein, a membrane translocation sequence linked to the C-terminus of the ubiquitin or ubiquitin-like protein, and a biologically active molecule linked to the C-terminus of the membrane translocation sequence is disclosed herein. A polynucleotide encoding the transmembrane fusion protein, a recombinant expression vector including the polynucleotide sequence, a cell transformed by the recombinant expression vector, and a method of delivering the biologically active molecule into a cell using the transmembrane fusion protein are also disclosed.

Abstract: There is provided a novel series of analogues of glucose-dependent insulinotropic polypeptide compounds, pharmaceutical compositions containing said compounds, and the use of said compounds as GIP-receptor agonists or antagonists for treatment of GIP-receptor mediated conditions, such as non-insulin dependent diabetes mellitus and obesity.

Abstract: The present invention relates to a novel chemical compound of formula S-(1): for use in the treatment of cancer, to compositions containing said compound, methods of manufacture and combinations with other therapeutic agents.

Abstract: A transdermal patch formulation of a viscous liquid that includes an active agent of incretin or incretin mimetic peptide, a stabilizer, a buffer, a water soluble thickening agent, and a pharmaceutically acceptable carrier. Also, a patch adapted for transdermal delivery of the active agent and having a drug reservoir compartment of the transdermal patch formulation and a system for facilitating transdermal delivery of the active agent through the skin of a subject. The system includes the patch and an apparatus capable of generating a plurality of micro-channels in an area on the subject's skin. The patch and apparatus are used in methods of treatment for reducing blood glucose level, lowering plasma glucagon levels, reducing food intake, or reducing gastric motility in a subject in need of the same by extending the release of the incretin or incretin mimetic peptide in the subject.

Abstract: Pharmaceutical compositions and methods for delivering a polypeptide to the central nervous system of a mammal via intranasal administration are provided. The polypeptide can be a catalytically active protein or an antibody, antibody fragment or antibody fragment fusion protein. The polypeptides are formulated with one or more specific agents.

Abstract: Disclosed is a mixture of: a bone/cartilage formation promoting agent containing sulfated galactosaminoglycan having greater than or equal to 0.6 numbers of ester sulfate groups on average per constituent monosaccharide or a salt thereof as an active ingredient; a factor having a bone/cartilage formation promoting action; or a bone filler (BMP, TGF-?, FGF, IGF, insulin, PDGF, HGF, midkine, pleiotrophin, collagen, gelatin, proteoglycan, fibronectin, osteocalcin, osteopontin, osteonectin, bone sialoprotein, hydroxyapatite, dicalcium phosphate anhydride, dicalcium phosphate dehydrate, ?-tricalcium phosphate, amorphous calcium phosphate, octacalcium phosphate, ?-tricalcium phosphate, PLLA, PLGA, titanium, decalcified bone, autogeneous bone, or the like).

Abstract: The present invention describes a method for identification and labeling of sentinel lymph nodes (SLNs) and the presence or absence of lymph node metastases as an important diagnostic and prognostic factor in early stage cancers of all types. The method, know as Molecular Lymphatic Mapping, uses traditional dye/radioactive tracer based techniques in conjunction with a nucleic acid marker to identify and label the SLN, not only for current diagnostic methods, but for archival purposes. In addition, MLM can be used to deliver a therapeutic gene or genes to the SLN to activate tumor immunity to tumor cells, and/or to inhibit tumor metastases. The methods may be combined with therapeutic intervention including chemotherapy and radiotherapy.

Abstract: This invention describes a method for delivery of a therapeutic agent to target cells. Liposome delivery vesicles binds to a specific cell population via a targeting molecule attached to the liposome surface. After the liposomes bind to a target cell they are internalized into compartments within the cell called endosomes. It has been shown by prior art that by encapsulating a pore forming bacterial hemolysin into the lumen of a liposome, the endosome is broken down and drug is delivered into the cell cytoplasm. Instead of encapsulating the hemolysin within the liposome, this invention improves on current techniques by associating the hemolysin with the lipid membrane of the liposome. This modification reduces development cost significantly, eases production methods and increases the effectiveness and versatility of the treatment. Using this technique, we have demonstrated effective targeting and killing of Her-2 overexpressing tumor cells.

Abstract: Compositions containing apoaequorin and methods for their use in treating symptoms and disorders related to calcium imbalances associated with, for example, sleep quality, energy quality, mood quality, memory quality or pain are provided by the present invention.

Abstract: The invention relates to a method for modulating neovascularisation comprising administering to a subject one or more compound selected from an isolated nucleic acid molecule comprising a gene selected from the group consisting of RIKEN cDNA 9430020K01, Agtrl1, Apelin, Stabilin 1, Stabilin 2, TNFaip8l1, TNFaip8 and FGD5, and homologues thereof; a gene product encoded by said genes or their homologues genes, and functional fragments thereof; an antibody or derivative thereof directed against a gene product of said genes or their homologues genes, and functional fragments thereof; an antisense molecule capable of binding to a gene or an mRNA gene product of said genes and homologues thereof; a small molecule interfering with a biological activity of a gene product of said genes and homologues thereof, and a (glyco)protein, a hormone and other biologically active compounds capable of interacting with said genes and homologues thereof or with a gene product thereof.

Abstract: Methods and systems for producing a change in a medium. A first method and system (1) place in a vicinity of the medium at least one upconverter including a gas for plasma ignition, with the upconverter being configured, upon exposure to initiation energy, to generate light for emission into the medium, and (2) apply the initiation energy from an energy source including the first wavelength ?1 to the medium, wherein the emitted light directly or indirectly produces the change in the medium. A second method and system (1) place in a vicinity of the medium an agent receptive to microwave radiation or radiofrequency radiation, and (2) apply as an initiation energy the microwave radiation or radiofrequency radiation by which the agent directly or indirectly generates emitted light in the infrared, visible, or ultraviolet range to produce at least one of physical and biological changes in the medium.

Abstract: Compositions and methods for mucosal delivery of agents are provided. The compositions are intended for administration to mucosal surface, such as oral, gastrointestinal and nasal mucosa. The compositions provided contain one or more mucoadhesive proteins and an agent to be delivered. Methods for delivery of agents using the compositions provided herein are also provided.

Abstract: A composition for transdermal delivery, particularly iontophoretic transdermal delivery, having at least one cationic active agent or a salt thereof. The composition comprises at least one cationic active agent or a salt thereof, at least one polyamine and/or polyamine salt, water or an aqueous solvent mixture, and optionally one or more additives. Use of the composition as a component of a transdermal patch or of an iontophoretic transdermal patch is also provided, as well as the use of the composition in a method for transdermally or iontophoretically administering cationic active agents. A method for determining the in vitro skin permeation properties of an active agent-containing iontophoretic composition is also provided.

Abstract: A system and method for producing a scaffold coated and/or impregnated with at least one bioactive agent. This is accomplished by culturing at least one cell in the same medium as a scaffold, but without physical contact between the at least one cell and the scaffold. The system includes a container having a surface defining an interior compartment. A medium is disposed within the interior compartment. At least one cell is disposed within the medium, the at least one cell being capable of producing at least one bioactive agent. Further, a scaffold is disposed within the medium. The scaffold is physically separated from the at least one cell such that there is no contact between the scaffold and the at least one cell. Thus, as the at least one cell produces at least one bioactive agent, such as a growth factor, the at least one bioactive agent enters the medium, and contacts and coats and/or impregnates the scaffold.

Abstract: The present invention relates generally to the use of antagonists of G-CSF, and/or its receptor (G-CSFR) in the treatment of uveitis. The present invention contemplates, therefore, the inhibition of G-CSF or G-CSFR systemically or locally and/or the down-regulation of expression of a G-CSF or G-CSFR in the treatment of uveitis.

Abstract: Ghrelin analogues having high affinity for a target receptor in diseased cells are provided, as well as methods of diagnosis and treatment utilizing such analogues.

Abstract: The present invention relates to a method of diagnosis of neonatal diabetes, congenital hypothyroidism and congenital glaucoma, comprising detecting the presence of a mutation in the GLIS3 gene and to a method for preparing functional pancreatic beta-cells by culturing human multipotent or pluripotent cells, such as embryonic stem cells (ES-cells) or human somatic stem cells in a culture medium comprising a effective amount of GLIS3 to induce said cells differenciation into functional pancreatic beta-cells producing insulin. It also relates to a pharmaceutical composition comprising GLIS3 as active ingredient.

Abstract: The present invention relates to novel methods of treating heart failure comprising administering an amount of stresscopin-like peptide to a subject in need thereof; and substantially maintaining the amount of said peptide present in the plasma of said subject at a concentration resulting in a therapeutic benefit without a substantial increase in the heart rate of said subject. The method involves the use of stresscopin-like peptides that are selective corticotrophin releasing hormone receptor type 2 (CRHR2) agonists.

Abstract: A method of preparing an oxidised polysaccharide-protein conjugate by oxidising a polysaccharide with an oxidising agent to form an oxidised polysaccharide and combining such oxidized polysaccharide with a protein. The oxidised polysaccharide is reacted with a protein to form a composition comprising a conjugate wherein the oxidised polysaccharide and the protein are conjugated via one or more imine bonds and wherein the oxidised polysaccharide comprises essentially no alpha-hydroxy aldehyde units. The conjugate may be used to provide sustained or latent activity of the protein.

Abstract: This invention relates to novel, substituted aralkyl heterocyclic compounds according to formula I, their derivatives, pharmaceutically acceptable salts thereof. This invention also provides compositions comprising a compound of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering aromatase inhibitors. Formula (I), or a pharmaceutically acceptable salt thereof, wherein: each R1 is independently selected from CH3, CH2D, CHD2 or CD3; each R2 is independently selected from CH3, CH2D, CHD2 or CD3; each Y is independently selected from H or D; and when each R variable is CH3, at least one Y is D.

Abstract: A method for treating a cancer is provided that comprises identifying a subject in need of treatment for a cancer and administering to the subject a composition that is comprised of a plurality of a ligand for a luteinizing hormone-releasing hormone receptor and a plurality of a chemotherapeutic agent, where each ligand and each chemotherapeutic agent are conjugated to a nanoparticle. Further provided are methods for detecting a cancer in a subject that comprise administering to a subject an imaging agent comprised of a plurality of a ligand for a luteinizing hormone-releasing hormone receptor conjugated to a nanoparticle.

Abstract: The present invention is directed to absorbable polyether esters that have been found to reduce bacterial adhesion to materials such as medical devices and implants. More specifically, the invention is directed to novel amorphous co-polymers comprising polyethylene diglycolate (PEDG) copolymerized with lactide-rich monomers.

Abstract: Invented are novel hetero-pyrrole compounds, the use of such compounds as inhibitors of protein kinase B activity and in the treatment of cancer and arthritis.

Abstract: Invented are novel hetero-pyrrole compounds, the use of such compounds as inhibitors of protein kinase B activity and in the treatment of cancer and arthritis.

Abstract: A pharmaceutical controlled release composition in solid dosage form is provided which comprises (I) a water-swellable linear polymer obtainable by reacting together: (a) a dried polyethylene oxide; (b) a dried C5 to C20 diol; and (c) a Bifunctional diisocyanate; and (II) a releasable pharmaceutically active agent.

Abstract: Disclosed are fusion proteins comprising a biologically active molecule and an immunoglobulin (Ig) Fc domain which is linked to the biologically active molecule. The Fc domain is a hybrid human Fc domain of (i) IgG1, IgG2 or IgG4 or (ii) IgG4 and IgD. The hybrid Fc is useful as a carrier of biologically active molecules.

Abstract: Methods for using compositions comprising oligosaccharide aldonic acids for general care, as well as for treatment and prevention, of various cosmetic conditions and dermatological disorders, including those associated with intrinsic and/or extrinsic aging, as well as with changes or damage caused by extrinsic factors; general care, as well as treatment and prevention of diseases and conditions, of the oral, and vaginal mucosa; for general oral care, as well as treatment and prevention of oral and gum diseases; and for wound healing of the skin. Methods may comprise using compositions comprising oligosaccharide aldonic acids and additional cosmetic, pharmaceutical or other topical agents to enhance or create synergetic effects.

Abstract: Disclosed are an injectable sustained-release pharmaceutical formulation and a process for preparing the same. In some embodiments, the formulation comprises an active ingredient in a therapeutically effective amount, an amphipathic molecule, an organic acid and/or a salt thereof which is hardly soluble in water, and an oily solvent. The injectable sustained-release pharmaceutical formulation provides a good sustained-release effect for various active ingredients, in particular peptides, proteins, nucleic acids and saccharides.

Abstract: Devices and methods for transmucosal drug delivery are provided. A device includes a housing configured for intralumenal deployment into a human or animal subject; a drug-dispensing portion which contains at least one drug; and a plurality of microneedles extending, or being extendable from, the housing, the plurality of microneedles being configured to disrupt at least one region of a mucosal barrier adjacent the housing at a selected time after being intralumenally deployed in the human or animal subject. The device is operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the plurality of microneedles.

Abstract: Specially designed GnRH II analogs that are resistant to degradation by peptidases, are disclosed. The GnRH II analogs incorporate D-Arg, D-Leu, D-tBu-Ser, D-Trp, D-Asn or other active D amino acids at position 6 and aza-Gly-amide or other amino acid-amide at position 10. The D-Arg (6)—GnRH II-aza-Gly (10)-amide, D-Asn—GnRH II-aza-Gly (10)-amide, and D-Leu(6)—GnRH II-aza-Gly(10)-amide analogs are also provided, and demonstrate preferential binding to immune system GnRH receptors. These GnRH II analogs or their antibodies may be used in pharmaceutical preparations, and specifically in treatment of various immune system disorders. Antibodies to GnRH II, Applicant's GnRH TI analogs, and GnRH receptors can be used for the detection of GnRH II or the GnRH II analog or the GnRH II receptors as a diagnostic tool and/or to monitor treatment.

Abstract: Intralumenal devices and methods are provided for transmucosal drug delivery. The device may comprise a housing configured for intralumenal deployment into a human or animal subject; a drug-dispensing portion which contains at least one drug; and an electrically-actuatable portion configured to disrupt at least one region of a mucosal barrier adjacent to the housing at a selected time while intralumenally deployed in the human or animal subject. The device may be operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the electrically-actuatable portion.

Abstract: A method to aid in identifying a familial or sporadic pattern of risk in at least one individual for developing cancer of a mucosal epithelial tissue, the method comprising screening said at least one individual for heterozygosity or homozygosity for a mutation in a gene coding for a Poly-Ig (Fc) receptor or a Poly-Ig-like (Fc) receptor capable of mediating inhibition of cancer cell growth by an immunoglobulin inhibitor. A method of treating an individual so identified includes enhancing the amount of immunoglobulin inhibitor contacting a mucosal epithelial tissue of said individual, and, especially in individuals homozygous for the defective receptor, may also include prophylactic surgery. Other methods include implementation of a risk reduction or prevention program in individuals identified as being at risk.

Abstract: Devices and methods are provided for transmucosal drug delivery. The transmucosal drug delivery device may include a housing configured for intralumenal deployment, such as intravaginally, into a human or animal subject; a drug-dispensing portion which contains at least one drug, the drug-dispensing portion being configured to dispense the drug from the housing by positive displacement; and a permeability enhancer-dispensing portion configured to release or generate a permeability enhancing substance to disrupt at least one region of a mucosal barrier adjacent to the housing at a selected time while intralumenally deployed in the human or animal subject. The device may be operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the permeability enhancing substance.

Abstract: Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.

Abstract: The present invention provides conjugates of peptide derivatives of the mammalian peptide hormones angiotensinogen, angiotensin I and angiotensin II, presented in a repetitive scaffold by coupling the peptide derivatives to a carrier, particularly a virus-like particle (VLP). The invention also provides methods of producing such conjugates, and immunotherapeutic uses of the resulting immunogen conjugates for the therapy and prophylaxis of conditions associated with the renin-activated angiotensin system.

Abstract: The present invention relates to methods and compositions for pretargeting delivery of therapeutic agents. In preferred embodiments, the pretargeting method comprises: a) administering a bispecific antibody with a first binding site for a disease-associated antigen and a hapten on a targetable construct; b) administering a targetable construct comprising at least one therapeutic agent. In preferred embodiments, the bispecific antibody is made by the dock-and-lock (DNL) technique. In a more preferred embodiment, the targetable construct comprises one or more SN-38 moieties.

Abstract: Described are compositions for topical application to keratinous tissues or substrates such as skin, or mucosal surfaces. The composition may be used to treat a skin condition or disease. The composition comprises at least one polypeptide and/or lipidated peptide and a carrier.

Abstract: A delivery device including at least one stinging capsule and methods of use are described.

Abstract: Improved biodegradable and bioabsorbable BAB-block copolymers exhibiting reverse thermal gellation properties, and aqueous polymer compositions including the BAB-block copolymers, are provided. Methods of making the improved BAB-block copolymers and compositions including the same are also provided.

Abstract: The present invention relates generally to a method for the treatment and prophylaxis of neurodegenerative diseases and conditions. More particularly, the present invention contemplates the treatment or prophylaxis of neurological conditions involving oligodendrocyte cytotoxicity or cell cycle arrest, demyelination and/or axonal or neuronal degeneration. Agents, medicaments and pharmaceutical compositions useful in the treatment and prophylaxis of neurodegenerative conditions and disorders also form part of the present invention.

Abstract: The present invention relates to a novel crustacean androgenic gland hormone. More specifically, the invention relates to an androgenic gland hormone derived from Penaeus monodon. The invention relates further to the use of the hormone to influence the sex ratio in prawn and shrimp cultures, and to set up monosex cultures. It is also related to the use of the hormone and its gene or fragments thereof in sex determination.

Abstract: The present invention provides a combination of compounds capable of modulating xenin activity and, insulin secretion and weight gain. The invention also provides methods for modulating GIP activity and insulin secretion in a subject, by modulating xenin activity in the subject.