Abstract: The present invention provides the use of PEG-IFN-&agr; conjugates in association with ribavirin for the treatment of chronic hepatitis C infections. The present invention also provides a method for treating chronic hepatitis C infections in patients in need of such treating comprising administering an amount of PEG-IFN-&agr;conjugate in association with an amount of ribavirin effective to treat hepatitis C.

Abstract: This invention relates to novel methods and formulations of nucleic acid pharmaceutical products, specifically formulations of nucleic acid vaccine products and nucleic acid gene therapy products.

Abstract: The present invention provides novel expression vectors which permit tight regulation of gene expression in eucaryotic cells. More specifically, the invention provides DNA vectors comprising nucleotide sequences that are transcribed to form RNA molecules which are then replicated by a temperature-sensitive replicase to form additional RNA molecules. The RNA molecules produced by replication contain a nucleotide sequence which may be translated to produce a protein of interest or which encode one or more untranslated RNA molecules. Also provided are methods for producing heterologous proteins and untranslated RNA molecules. Further provided are methods for administering heterologous proteins and untranslated RNA molecules to individuals. In addition, pharmaceutical compositions are provided comprising the DNA and RNA molecules of the invention and a pharmaceutically acceptable carrier.

Abstract: The present invention provides a method of modulating neovascularization in an animal. The method comprises administering to the animal two or more nucleic acid sequences, each nucleic acid sequence encoding at least one angiogenesis-modulation factor that acts upon a different angiogenic process, such that the nucleic acid sequences are expressed to produce the angiogenesis-modulation factors to modulate neovascularization in the animal. Modulating neovascularization includes the induction of neovascularization or, in the alternative, the inhibition or reduction of neovascularization.

Abstract: The present invention provides genetically-engineered parvovirus capsids and viruses designed to introduce a heterologous gene into a target cell. The parvoviruses of the invention provide a repertoire of vectors with altered antigenic properties, packaging capabilities, and/or cellular tropisms as compared with current AAV vectors.

Abstract: The present invention relates to the use of RAR&bgr;2 and/or an agonist thereof in the preparation of a medicament to cause neurite development.

Abstract: The present invention provides a method for the in vitro culture of embryonic stem cells, wherein the stem cells continue to express no antigen or antigen CD117, and mostly remain undifferentiated during culture. The present invention also relates to purified preparations of embryonic stem cells and for uses of embryonic stem cells in treating a wide variety of conditions, diseases and disorders.

Abstract: Described herein are isolated polynucleotides which code for an AMPA-type human CNS receptor, designated the human GluR4B receptor. The receptor is characterized structurally and the construction and use of cell lines expressing the receptor is disclosed.

Abstract: Disclosed is a method of directing a cellular response in a mammal by expressing in a cell of the mammal a chimeric receptor which causes the cells to specifically recognize and destroy an infective agent, a cell infected with an infective agent, a tumor or cancerous cell, or an autoimmune-generated cell. The chimeric receptor includes an extracellular portion which is capable of specifically recognizing and binding the target cell or target infective agent, and (b) an intracellular portion of a protein-tyrosine kinase which is capable of signalling the therapeutic cell to destroy a receptor-bound target cell or a receptor-bound target infective agent. Also disclosed are cells which express the chimeric receptors and DNA encoding the chimeric receptors.

Abstract: The present invention is directed to association of nuclear receptor tyrosine kinase, such as EGFR, with highly proliferative tissue following its translocation from the cell membrane. The nuclear localization of the receptor tyrosine kinase is affiliated with transcription activity, and the specific sequence associated with such activity, particularly for EGFR, is disclosed.

Abstract: The present invention provides a method for the in vitro culture of embryonic stem cells, wherein the stem cells continue to express no antigen or antigen CD117, and mostly remain undifferentiated during culture. The present invention also relates to purified preparations of embryonic stem cells and for uses of embryonic stem cells in treating a wide variety of conditions, diseases and disorders.

Abstract: The present invention provides a method for the in vitro culture of embryonic stem cells, wherein the stem cells continue to express no antigen or antigen CD117, and mostly remain undifferentiated during culture. The present invention also relates to purified preparations of embryonic stem cells and for uses of embryonic stem cells in treating a wide variety of conditions, diseases and disorders.

Abstract: The present invention comprises a method of protecting organs or tissue susceptible to reperfusion-induced dysfunction after ischemia. The method comprises parenterally administering to a patient a therapeutical composition containing natural alpha-1 acid glycoprotein, natural alpha-1 antitrypsin or a mixture thereof. Alternatively, organ or tissue transplants can be contacted with natural alpha-1 acid glycoprotein, natural alpha-antitrypsin or mixtures by perfusing or flushing them with a solution containing natural alpha-1 acid glycoprotein, natural alpha-1 antitrypsin or mixtures thereof in a concentration of 0.1 to 5 g/l.

Abstract: The present invention is related to an isolated and purified enzyme with xylanolytic activity having more than 70% homology with the amino acid sequence SEQ ID NO 11.

Abstract: The present invention provides an anti-pathogen system comprising one or more fusion proteins that includes a transduction domain and a cytotoxic domain. The cytotoxic domain is specifically activated by a pathogen infection. The anti-pathogen system effectively kills or injures cells infected by one or a combination of different pathogens. Further provided are protein transduction domains that provide enhanced transduction efficiency.

Abstract: A method of producing libraries of genes encoding antigen-combining molecules or antibodies is described. In addition, a method of producing antigen-combining molecules which does not require an in vivo procedure is described. Vectors useful in the present method and antigen-combining molecules produced by the method are discussed. The antigen-combining molecules are useful for the detection, quantitation, purification and neutralization of antigens, as well as for diagnostic, therapeutic and prophylactic purposes.

Abstract: The invention relates to the determination of a genetic loci and genes therein which are related to an increased susceptibility to the development of systemic autoimmunity, specifically, systemic autoimmune erythematosus. The loci and genes were isolated utilizing a strategy based on the generation and phenotypic analysis of congenic recombinants to identify SLE susceptibility genes in NZM2410 mice. The elucidated genes facilitate screening for susceptibility as well as use in therapeutic and prophylactic roles. In addition, the murine model may be used in the screening of compounds which may be of therapeutic or prophylactic benefit in the treatment of systemic autoimmune disorders.

Abstract: A humanized form of an antiidiotype antibody to CEA, e.g., hWI2, has conserved immunoreactivity. The clinical benefits of antiCEA antibodies are maximized by using the humanized antiidiotype as a clearing agent for antiCEA antibodies or antibody fragments. The humanized antiidiotype also can be used as an immunogenic vaccine.

Abstract: Anti-TNF antibodies, fragments and regions thereof which are specific for human tumor necrosis factor-&agr;(TNF&agr;) and are useful in vivo diagnosis and therapy of a number of TNF&agr;-mediated pathologies and conditions, as well as polynucleotides coding for murine and chimeric antibodies, methods of producing the antibody, methods of use of the anti-TNF antibody, or fragment, region or derivative thereof, in immunoassays and immunotherapeutic approaches are provided.

Abstract: The present invention describes monoclonal antibodies which are useful for the specific detection and therapy of diffuse gastric carcinoma. Further embodiments describe therapeutic and diagnostic means for the detection and for the therapy of diffuse gastric carcinomas as well as methods for the detection and therapy of diffuse gastric carcinomas.

Abstract: The present invention relates to a method for producing patient specific anti-cancer antibodies using a novel paradigm of screening. By segregating the anti-cancer antibodies using cancer cell cytotoxicity as an end point, the process makes possible the production of anti-cancer antibodies customized for the individual patient that can be used for therapeutic and diagnostic purposes. The invention further relates to the process by which the antibodies are made and to their methods of use. The antibodies can be made specifically for one tumor derived from a particular patient and are selected on the basis of their cancer cell cytotoxicity and simultaneous lack of toxicity for non-cancerous cells. The antibodies can be used in aid of staging and diagnosis of a cancer, and can be used to treat tumor metastases.

Abstract: The present invention relates to compositions and methods for intracellular protein delivery. The compositions include a protein operatively associated with a cationic lipid in such a way as to facilitate intracellular delivery of the protein by the cationic lipid, such as by associating directly with a cationic lipid, encapsulating it in a cationic liposome, associating the protein with a lipoplex comprising cationic lipid and nucleic acid, or associating the protein with an anionic polymer that is in association with a cationic lipid. These compositions are useful in delivering antibodies to intracellular proteins to neutralize their activity, and to introduce therapeutically useful proteins, peptides or small molecules.

Abstract: Mycobacterium tuberculosis protein having a molecular weight of 28,799 Da, and hybrid protein containing at least portions of its sequence.

Abstract: A vaccine for the treatment or prophylaxis of C. difficile associated disease comprises a C. difficile gene or a C. difficile peptide/polypeptide or a derivative or fragment or mutant or variant thereof which is immunogenic in humans. The gene encodes a C. difficile surface layer protein, SlpA or variant or homologue thereof. The peptide/polypeptide is a C. difficile surface layer protein, SlpA or variant or homologue thereof. The vaccine may comprise a chimeric nucleic acid sequence.

Abstract: The invention provides compositions and processes for the production of ordered and repetitive antigen or antigenic determinant arrays. The compositions of the invention are useful for the production of vaccines for the prevention of infectious diseases, the treatment of allergies and the treatment of cancers. Various embodiments of the invention provide for a core particle that is coated with any desired antigen in a highly ordered and repetitive fashion as the result of specific interactions.

Abstract: The present invention relates to the field of immunology and human medicine, in particular with a vaccine preparation able to provoke an immune-castration of self-TGF&agr;.

Abstract: This invention provides methods of eliciting a secretry IgA-mediated immune response in a subject by administering a Pseudomonas exotoxin A-like chimeric immunogens that include a non-native epitope in the Ib domain of Pseudomonas exotoxin.

Abstract: The present invention provides polypeptides comprising an immunogenic epitope of a M. vaccae protein, polynucleotides encoding such polypeptides, and fusion proteins comprising at least one such polypeptide, together with genetic constructs comprising at least one inventive polynucleotide. Compositions comprising such polypeptides, polynucleotides, fusion proteins and/or genetic constructs may be employed in the treatment of infectious diseases and immune disorders.

Abstract: The present invention provides a method for preventing/slowing aging and/or reducing menopause symptoms in humans by orally administering an effective amount of germination-activated Ganoderma lucidum spores (GLSs) to humans. The treatment for menopause is especially effective in male patients. GLSs are effective as an antioxidant to reduce free radical damage, particularly by increasing the amount of the reduced form glutathione (GSH) and the superoxide dismutase (SOD) activity. GLSs can also increase testosterone level in blood and improve depression, particularly geriatric depression, in elderly male patients.

Abstract: Sympathetic nerve-stimulating fragrant compositions with weight-loss effects, characterized by containing one or more selected from among fennel oil, grapefruit oil, pepper oil, hyssop oil, sage oil, estragon oil, eucalyptus oil, rosemary oil, cinnamon oil, clove oil, ylang ylang oil, ginger oil, geranium oil and olibanum, or one or more from among limonene, pinene, myrcene and benzyl benzoate as the active ingredients in the oils, and preferably also containing caffeine.

Abstract: Methods and compositions for protecting avian hosts (e.g., turkeys and/or chickens) from turkey rhinotracheitis virus and/or TRT or SHS respiratory distress utilize in ovo administration of live, avirulent strains of TRTV at appropriate dosage levels on a per egg basis to provide an effective and efficient vaccination having acceptable safety and efficacy features, and additionally provides higher titers in vaccinated birds than conventionally administered vaccines.

Abstract: A method for applying a topical anesthetic to an area of skin comprising the steps of a) incorporating an anesthetic in a lipophilic base into a volatile solvent, to form a homogeneous solution; b) applying the homogeneous solution into the area of skin to be treated; and c) evaporating the volatile solvent from the homogeneous solution; wherein the volatile solvent is present in the formulation in amounts between 40-80%; and wherein said topical anesthetic rapidly penetrates the skin surface at said skin, leaving a cooling sensation on the skin. The topical anesthetic formulation contains a penetrating enhancer carrier that markedly enhances the delivery of the anesthetic across human skin without altering the acceptable delivery rate of the anesthetic that needs to be delivered through the skin and leaves a cooling sensation on the skin.

Abstract: The present invention provides methods for preventing and/or treating bleeding episodes by administering a single dose of Factor VIIa or a Factor VIIa equivalent. Preferably, the single dose comprises between about 150 and about 500 ug/kg Factor VIIa or Factor VIIa equivalent.

Abstract: The invention provides wet skin treatment compositions for use during bathing. The compositions are activated by water and retained efficiently on skin. The compositions impart desirable benefits to skin, are perceived to absorb quickly on wet skin, and leave the skin feeling clean, but non-greasy.

Abstract: This invention relates to reducing sebum production on the skin using methods and compositions containing a surfactant, a chylomicron disrupter, a skin penetration enhancer, and an anti-androgenic compound. In a preferred embodiment, the composition contains the surfactant as a mixture of polyoxyethylene compounds and the anti-androgenic agent as a mixture of saw palmetto extract and nettle extract.

Abstract: 7-Oxo-DHEA derivatives, various of which are themselves novel compounds, are well suited for cosmetically/therapeutically treating adverse conditions/afflictions of a keratinous substrate/material, notably of human skin, hair, eyelashes and nails, to improve the appearance thereof, in particular to prevent or treat signs of aging of the skin and/or a dull complexion and/or skin or hair pigmentation disorders and/or dryness of the skin and/or hyperseborrhoea and/or hyperseborrhoea-related imperfections and/or sensitive skin and/or dandruff and/or natural hair loss and/or baldness.

Abstract: A matrix, including epithelial basement membrane, for inducing repair of mammalian tissue defects and in vitro cell propagation derived from epithelial tissues of a warm-blooded vertebrate.

Abstract: A method of transplanting a graft in the subretinal area of a host eye comprises preparing the graft by harvesting from the donor tissue a population of cells in a manner that maintains the population of cells in the same organization and cellular polarity as is present in normal tissue of that type. The population of cells are of a sheet-like form and are assembled with a relatively thin flexible pliable carrier composed of a non-toxic flexible composition which substantially dissolves at body temperature to form a graft. The graft is sufficiently flexible and pliable to be coiled to form a volute (76) without disturbing the organization and polarity of the cells. The method further comprises coiling the graft to form a volute (76) with the convolutions of the volute (76) free of one another for subsequent uncoiling of the graft substantially to its original sheet-like form. An incision is made in the host eye for insertion of the volute (76).

Abstract: A process for coating a perforated substrate with a gel (e.g. a polymerised acrylate hydrogel or a xerogel) without substantial occlusion of the perforations comprises (i) forming a layer of a liquid pregel mixture, comprising one or more monomers, on a web coated with a silicone, polyethylene, Teflon (R) or other coating having a surface energy less than the surface energy of the liquid pregel mixture. Preferably at least part of the curing takes place while the liquid pregel mixture is in contact with both the perforated substrate and the web. The process is especially applicable to the manufacture of attachment tabs for wigs and toupees, wound dressings, patches for transdermal drug delivery, therapeutic patches or biomedical electrodes.

Abstract: This invention relates to non-contact printing methods of making medical pressure sensitive adhesive articles. A base layer is coated onto a substrate and a liquid composition is non-contact printed onto at least a portion of the base layer to provide a medical pressure sensitive adhesive article. The medical pressure sensitive adhesive article comprises at least one medicinal ingredient intended to have a medicinal or therapeutic effect. More specifically this invention relates to non-contact printing methods of making transdermal drug delivery devices.

Abstract: The present invention relates to patches for the administration of an athletic supplement to subjects engaged in rigorous exercise or heavy outdoor work. The invention also relates to methods of administering nutrients to subjects using the patch of the invention.

Abstract: The present invention is directed to charged lipids, compositions comprising charged lipids, and the use of these compositions in drug delivery, targeted drug delivery, therapeutic imaging and diagnostic imaging, as well as their use as contrast agents.

Abstract: Conjugates of a hydrophobic moiety, such as a lipid, linked through a cleavable dithiobenzyl linkage to a therapeutic agent are described. The dithiobenzyl linkage is susceptible to cleavage by mild thiolysis, resulting in release of the therapeutic agent in its original form. The linkage is stable under nonreducing conditions. The conjugate can be incorporated into liposomes for administration in vivo and release of the therapeutic agent in response to endogeneous in vivo reducing conditions or in response to administration of an exogeneous reducing agent.

Abstract: The present invention is directed to coadministration of the fibrinogen receptor antagonists 3S-[[4-[[4-aminoiminomethyl)phenyl]amino]-1,4-dioxobutyl]amino]-4-pentynoic acid or ethyl 3S-[[4-[[4-(aminoiminomethyl)phenyl]amino]-1,4-dioxobutyl]amino]-4-pentynoate together with an anti-platelet agent such as aspirin and/or an anti-coagulant such as heparin.

Abstract: A composition for treating pruritus, comprising a compound selected from the group consisting of opioid receptor antagonists, opioid receptor agonists/antagonists, and pharmaceutically acceptable salts thereof, and a compound useful in treating the cause of the pruritus. This invention also relates to a method of treating pruritus using such compositions, and a method for preparing these compositions.

Abstract: A once a day bupropion hydrochloride formulation is disclosed.

Abstract: A stabilized solid cqntrolled release dosage form having a coating derived from an aqueous dispersion of ethylcellulose is obtained by overcoating a substrate including a therapeutically active with an aqueous dispersion of ethylcellulose and then curing the coated substrate at a temperature and relative humidity elevated to a suitable level above ambient conditions until the coated dosage form attains a stabilized dissolution profile substantially unaffected by exposure to storage conditions of elevated temperature and/or elevated relative humidity.

Abstract: The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.

Abstract: Physiologically acceptable films, including edible films, are disclosed. The films include a water soluble film-forming polymer such as pullulan. Edible films are disclosed that include pullulan and antimicrobially effective amounts of the essential oils thymol, methyl salicylate, eucalyptol and menthol. The edible films are effective at killing the plaque-producing germs that cause dental plaque, gingivitis and bad breath. The film can also contain pharmaceutically active agents. Methods for producing the films are also disclosed.

Abstract: Cell storage and delivery systems and methods for storing and delivering viable cells to a mammal are disclosed. The cell storage and delivery systems include a biodegradable and/or bioabsorbable fibrous matrix physically associated with viable cells to contain and release the cells at a controlled rate. The biodegradable and/or bioabsorbable matrix can be formed by electrospinning fibers of biodegradable and/or bioabsorbable fiberizable material. The methods include methods for storing viable cells and for delivering viable cells to a mammal using the cell storage and delivery system.