Abstract: This application discloses methods, systems and kits for correlating the presence or absence of certain nucleic acid sequences within a population with the ability to create immune tolerance in that same population. Tolerance can be induced by solo or repeated administration of antigen, including soluble antigens administered either intravenously or sublingually. This application also discloses methods for detecting variants. In addition the application addresses the use or avoidance of non steroidal anti inflammatory drugs in therapy.

Abstract: Methods for generating pancreatic stem cells from a pancreatic tissue of 24-week old mice by transient overexpression of reprogramming factors combined with Pdx1 selection is described herein. The generated cells were designated as iPaS (induced pancreatic stem) cells and exhibit the same morphology as the pancreatic stem cells previously established from young donors without genetic manipulation and express genetic markers of endoderm and pancreatic progenitors. Transplantation of the iPaS cells into nude mice resulted in no teratoma formation. Moreover, iPaS cells were able to differentiate into insulin-producing cells more efficiently than ES cells. In addition, the technology of transient overexpression of reprogramming factors and tissue-specific selection of the present invention may also be useful for the generation of other tissue-specific stem cells.

Abstract: A method for inducing and enhancing neurogenesis and/or oligodendrogenesis from endogenous as well as from exogenously administered stem cells comprises administering to an individual in need thereof an agent selected from the group consisting of Copolymer 1, a Copolymer 1-related polypeptide, a Copolymer 1-related peptide, and activated T cells which have been activated by Copolymer 1, a Copolymer 1-related polypeptide, or a Copolymer 1-related peptide. The method is particularly useful for stem cell therapy in combination with the agent.

Abstract: The present invention relates to embedding live or dead microorganisms and/or bioactive materials in a protective dry formulation matrix, wherein the formulation includes the bioactive microorganism or material, a formulation stabilizer agent, and a protective agent. The formulation is prepared by dispersing all the solid components in a solution, with or without a vacuum, and cooling the solution to a temperature above its freezing temperature. The methods include a primary drying step of the formulation at a desired temperature and time period, and an accelerated secondary drying step under maximum vacuum and elevated temperature, to achieve a final desirable water activity of the dry material.

Abstract: Monoclonal antibodies, or antigen-binding fragments thereof, that bind to ERG, and more specifically, to an epitope formed by amino acids 42-66 of ERG3 are disclosed. The monoclonal antibodies can be non-human antibodies (e.g., rabbit or mouse) or humanized monoclonal antibodies having the CDR regions derived from those non-human antibodies. In other embodiments, the monoclonal antibodies are chimeric, having the light and heavy chain variable regions of a non-human ERG anti-body. Methods of using the antibodies to detect ERG, or fusion proteins comprising all or part of an ERG polypeptide, such as an ERG polypeptide encoded by a TMPRSS2/ERG, SLC45A3/ERG, or NDRG1/ERG fusion transcript, are also provided, including methods of detecting ERG or ERG fusion events in a clinical setting.

Abstract: The present invention is related to peptides that can be used to reduce the immune response against FVIII or to induce tolerance to human FVIII in patients with, e.g., hemophilia A. Furthermore, the peptides can be used for immunodiagnostic purposes to detect FVIII-specific CD4+ T cells to monitor patients with hemophilia A during replacement therapy and during immune tolerance induction therapy.

Abstract: Peptide vaccines against cancer are described herein. In particular, epitope peptides derived from the TTK gene that elicit CTLs are provided. Antigen-presenting cells and isolated CTLs that target such peptides, as well as methods for inducing the antigen-presenting cell, or CTL are also provided. The present invention further provides pharmaceutical compositions containing as active ingredients peptides derived from TTK or polynucleotides encoding the peptides. Furthermore, the present invention provides methods for the treatment and/or prophylaxis (i.e., prevention) of cancers (tumors), and/or the prevention of postoperative recurrence thereof, as well as methods for inducing CTLs, methods for inducing anti-tumor immunity, using the peptides derived from TTK, polynucleotides encoding the peptides, or antigen-presenting cells presenting the peptides, or the pharmaceutical compositions of the present invention.

Abstract: The present invention relates to use of a new cell penetrating peptides (CPP) and in particular to the region 32-51 of protein Limulus antilipopolisacárido (LALF) and its analogous. This invention refers to compositions containing these peptides associated to biomolecules with therapeutics properties. This invention consist of compositions comprise the covalent fusion of biomolecules, between this human papillomavirus antigens (HPV) to these CPP for induce a potent immune cellular responses against HPV and HPV protein antigen-exhibiting cells including HPV-associated tumors. The referred compositions are applicable in the pharmaceutical industry as vaccine for therapeutic use in human.

Abstract: The present invention relates to nucleic acids encoding the novel parvoviral protein “assembly activating protein” (AAP), the encoded polypeptides, methods of producing the polypeptides, antibodies specific for AAP, the use of the nucleic acids for the preparation of the polypeptides, the use of the nucleic acids or the polypeptides for the preparation of the parvoviral particle and methods of producing parvoviral particles essentially consisting of VP3 by providing in addition to the coding sequence of the parvoviral structural protein VP3 a sequence fragment Z/a nucleic acid encoding AAP in the cell and expressing VP3 and fragment Z under control of a rep-independent promoter. Furthermore, the present invention relates to parvoviral particles essentially consisting of VP3 and/or obtainable by the above method as well as expression cassettes comprising (i) a heterologous promoter and (ii) VP3 coding sequence and/or fragment Z.

Abstract: Polypeptides, polynucleotides, methods, compositions, and vaccines comprising influenza hemagglutinin and neuraminidase variants are provided.

Abstract: The invention provides proteins from Neisseria meningitidis, including the amino acid sequences and the corresponding nucleotide sequences. The proteins are predicted to be useful antigens for vaccines and/or diagnostics.

Abstract: The present invention provides novel chlamydia antigens, nucleic acids encoding the antigens, and immunogenic compositions including the antigens. The present invention further provides methods of using the antigens to elicit immune responses (e.g., T cell-mediated and/or B cell-mediated immune responses). The present invention provides methods of prophylaxis and/or treatment of chlamydia-mediated diseases comprising administering an immunogenic composition including one or more of the novel antigens described herein.

Abstract: Compositions comprising a first biological molecule from a Neisseria bacterium and a second biological molecule from a Neisseria bacterium. The term “biological molecule” includes proteins and nucleic acids. Preferred Neisseria species are N. meningitidis and N. gonorrhoeae.

Abstract: Chimera proteins including: (i) at least one sequence of a DbpA protein of a Borrelia species selected from B. afzelii, B. burgdorferi sensu stricto and B. garinii, and (ii) at least one sequence of an OspC protein of a Borrelia species selected from B. afzelii, B. burgdorferi sensu stricto and B. garinii. Also, a method and a kit for the in vitro diagnosis of Lyme borreliosis using said proteins.

Abstract: The present disclosure provides immunogenic compositions that include at least two paramyxovirus F protein antigens selected from human metapnuemovirus (hMPV), paarainfluenza virus (PIV) and respiratory syncytial virus (RSV). The antigens of the disclosed compositions are recombinant F protein polypeptides, which have been modified to stabilize the trimeric prefusion conformation. Nucleic acids encoding the antigens, as well as methods for their production and use are also provided.

Abstract: The present invention provides an improved method for the purification of a mixture of complexes comprising a stress protein complexed to a peptide or peptide fragment from a source mixture, typically a cell lysate. The method of the invention provides for protein complexes to be purified using ion exchange chromatography based methods, wherein a modified buffer solution is used which results in the purified stress protein complexes being more immunogenic than protein complexes obtained using conventional methodology. The purified complexes can be used to produce improved vaccine preparations which elicit enhanced immune responses in the subjects to whom the vaccine compositions are administered.

Abstract: This invention is directed to processes for reducing the level of free carbohydrate from a solution of protein-linked carbohydrate (conjugate) and non-linked carbohydrate. In this process, the conjugate is adsorbed to a hydrophobic membrane while the carbohydrate is not. The conjugate is then desorbed from the membrane, yielding a solution that is substantially reduced in free carbohydrate.

Abstract: A method of enhancing an immune response to an antigen is provided. The method involves augmenting the level of a TAP molecule in a target cell bearing the antigen. Preferably, the TAP molecules enhanced by administering a nucleic acid sequence encoding a TAP-1 and/or TAP-2 molecule. The method is useful in treating infectious diseases and cancer.

Abstract: The present invention relates to a recombinant Modified Vaccinia virus Ankara (MVA) comprising in the viral genome one or more expression cassettes for the expression of HIV proteins selected from Gag, Pol, Tat, Vif, Vpu, Vpr, Rev and Nef or a part or a derivative thereof or selected from Gag, Pol, Vpu, Vpr, Rev and Nef or a part or a derivative thereof for use as medicament or vaccine and its use for the treatment and/or prevention of HIV infections and AIDS.

Abstract: The invention is directed to an episomal recombinant nucleic acid encoding at least two heterologous antigens each fused to a PEST-endogenous polypeptide, vaccines comprising the same, methods of preparing same, and methods of inducing an immune response, and treating, inhibiting, or suppressing cancer or tumors comprising administering the same.

Abstract: This invention relates to non-integrating, non-replicating retroviral vectors that cause an immune response in an animal host when administered to the host. The vectors transduce cells in the host, where they produce virus-like particles (VLPs), which stimulate an additional immune response in the host when they are released from the cells. The vectors are non-integrating, non-replicating retroviral vectors comprising long terminal repeats, a packaging sequence, and a heterologous promoter operably linked to one or more polynucleotide sequences that together encode the structural proteins of a virus. Methods of making and using the vectors are also disclosed.

Abstract: The invention relates to methods for the induction of an immune response to dengue virus. The method of inducing an immune response against dengue virus comprises administration of a non-replicating immunogen followed by a boost with a tetravalent live attenuated viral vaccine. Another aspect of the inventive subject matter is a method of inducing an immune response against dengue virus using a heterologous prime-boost regimen with the priming immunogen comprising a DNA expression system, an adenovirus expression vector or a Venezuelan equine encephalitis virus replicon system and the boosting immunogen comprising the same without the DNA expression system. Each expression system contains DNA sequences encoding dengue viral proteins.

Abstract: The subject of the present invention is a bacterial composition having immunomodulation properties comprising at least one strain selected from the group consisting of Lactobacillus acidophilus PTA-4797, Lactobacillus plantarum PTA-4799, Lactobacillus salivarius PTA-4800, Lactobacillus paracasei PTA-4798, Bifidobacterium bifidum PTA-4801 and Bifidobacterium lactis PTA-4802. An other subject of the invention is an immunomodulation method comprising the step of using the at least one strain selected from the preceding group.

Abstract: The present invention is based, in part, on flagellin adjuvant used to enhance immune responses directed against Streptococcus pneumoniae, in particular, to enhance immune responses to polypeptide antigens (e.g., PspA) and capsular polysaccharide from S. pneumoniae. In representative embodiments, the invention provides a fusion protein comprising a flagellin adjuvant and one more polypeptide antigens from S. pneumoniae. In other embodiments, the invention provides a conjugate comprising a flagellin adjuvant covalently linked to a capsular polysaccharide from one or more serotypes of S. pneumoniae. Also provided are compositions comprising the fusion proteins and/or conjugates of the invention as well as immunogenic formulations comprising the inventive fusion proteins, conjugates and/or compositions. The invention also provides methods of producing an immune response against S. pneumoniae and methods of protecting a subject from S.

Abstract: Vaccines for conferring immunity in mammals to infective pathogens are provided, as well as vectors and methods for plastid transformation of plants to produce protective antigens and vaccines for oral delivery. The invention further provides transformed plastids having the ability to survive selection in both the light and the dark, at different developmental stages by using genes coding for two different enzymes capable of detoxifying the same selectable marker, driven by regulatory signals that are functional in proplastids as well as in mature chloroplasts. The invention utilizes antibiotic-free selectable markers to provide edible vaccines for conferring immunity to a mammal against Bacillus anthracis, as well as Yersina pestis. The vaccines are operative by parenteral administration as well. The invention also extends to the transformed plants, plant parts, and seeds and progeny thereof. The invention is applicable to monocot and dicot plants.

Abstract: Embodiments of this invention include lipid-based immunogenic compositions (adjuvants or carriers) useful for oral or gastrointestinal administration for improving mucosal immune responses in animals vaccinated for a variety of bacterial infections. In certain embodiments, lipid compositions of this invention include a mixture of fatty acids having different chain lengths, thereby providing desired physico-chemical properties. When a bacterial antigen is mixed with a lipid-based adjuvant or carrier, the resulting composition elicits improved mucosal immune responses and thereby decreases infections and sequellae of disease caused by Chlamydia or Helicobacter.

Abstract: The present invention relates to a Mycoplasma hyopneumoniae vaccine strain comprising a mutation in at least one of the genes listed or as deposited with the National Measurements Institute (Australia) under accession number NM04/41259, which strain is temperature sensitive and attenuated, a vaccine comprising such strains and methods and uses thereof.

Abstract: The present invention relates to a compound of structural formula (I) and its derivatives for use as medicinal drugs. They are preferably immunosuppressive agents, with mechanism of action based on the blockage of TCR-Nck interaction.

Abstract: Methods of treating, preventing or managing leukemias are disclosed. The methods encompass the administration of an immunomodulatory compound of the invention. The invention further relates to methods of treatment using an immunomodulatory compound with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy. Pharmaceutical compositions and single unit dosage forms suitable for use in the methods of the invention are also disclosed.

Abstract: Isolated cells are described that are not embryonic stem cells, not embryonic germ cells, and not germ cells. The cells can differentiate into at least one cell type of each of at least two of the endodermal, ectodermal, and mesodermal lineages. The cells do not provoke a harmful immune response. The cells can modulate immune responses. As an example, the cells can suppress an immune response in a host engendered by allogeneic cells, tissues, and organs. Methods are described for using the cells, by themselves or adjunctively, to treat subjects. For instance, the cells can be used adjunctively for immunosuppression in transplant therapy. Methods for obtaining the cells and compositions for using them also are described.

Abstract: The present invention relates to the fields of hydration and nutrition for dysphagic patients. In particular, the present invention relates to thickeners comprising probiotic microorganisms and to compositions comprising such thickeners. The probiotic micro-organisms may be non-replicating probiotic micro-organisms such as bioactive heat treated probiotic microorganisms.

Abstract: Bioengineered collagen constructs with antimicrobial properties are provided. The bioengineered collagen constructs comprise a sheet-like layer of purified collagenous tissue matrix derived from a tissue source, such as the tunica submucosa of small intestine or a processed intestinal collagen layer derived from the tunica submucosa of small intestine, treated with an antimicrobial agent. The constructs are biocompatible. The present invention has a variety of applications, including wound dressing and surgical repair devices. Methods for treating a damaged or diseased soft tissue are provided. Methods for treating a wound in need of care and treatment are also disclosed.

Abstract: A new particle morphology of glucocorticosteroids is described. The forms have a particle morphology that is particularly well suited for use in an inhaled corticosteroid drug suspension formulation for delivery from a next generation nebulizer device. Use of the new glucocorticosteroid particles enables enhanced drug delivery efficiency and increased residence time of the delivered drug in the lungs. New methods for producing glucocorticosteroid particles having these specific particle morphologies are also described. The methods provide a simplified, reproducible and scalable particle formation process that can produce glucocorticosteroid particles having a narrow particle size and shape distribution, a low surface energy, a low aspect ratio, uniform particle morphology and a reduced specific surface area.

Abstract: The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.

Abstract: The present invention relates to methods for producing particles of indomethacin using dry milling processes as well as compositions comprising indomethacin, medicaments produced using indomethacin in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of indomethacin administered by way of said medicaments.

Abstract: Methods for producing tissue engineered constructs and engineered native tissues include producing a tissue engineered construct by growing cells in vitro on a substrate and then decellularizing the construct to produce a decellularized construct consisting largely of extracellular matrix components. The construct can be used immediately or stored until needed. The decellularized construct can be used for further tissue engineering, which may include seeding the construct with cells obtained from the intended recipient of the construct. During any of the growth phases required for production of the construct, the developing construct may be subjected to various tissue engineering steps such as application of mechanical stimuli including pulsatile forces.

Abstract: Methods and compositions for reducing the frequency of urination are disclosed. One method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising an analgesic agent formulated in an extended-release formulation. Another method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising multiple active ingredients formulated for extended-release. Yet another method comprises administering to a subject in need thereof an effective amount of a diuretic followed with another administration of an pharmaceutical composition comprising an analgesic agent formulated for extended-release.

Abstract: The present invention relates to the generation of vascularized human heart tissue from human primordial Islet1-positive (ISL1+) progenitors, and more particularly the generation of vascularized human heart tissue from human primordial Islet1+ cardiovascular stem cells which are positive for markers ISL1+/NKX2.5?/KDR?. One aspect of the invention relates to isolation of human ISL1+ primordial cells from human pluripotent cells, such as human ES cells or other human pluripotent stem cell sources, wherein the human ISL1+ primordial cells can differentiate into three different lineages; cardiomyocyte lineages, endothelial lineages and smooth muscle lineages. Another aspect relates to use and implantation of the human primordial ISL1+ progenitors into an animal model to generate human vascularized heart tissue, and more particularly, the production of an in vivo humanized model of vascular disease.

Abstract: A method for preparing a composition of metal nanocrystals from at least one organometallic precursor in a solvent medium in the presence of a PEG ligand, including a carbon chain, at least one end of which is functionalized by a coordination grouping including at least one hetero atom, and having at least one [OCH2CH2]n grouping, n being an integer higher than 1, so as to be soluble both in the solvent medium and in water. The water-compatible and organic-compatible composition of metal nanocrystals thus obtained is also described.

Abstract: The present invention is directed to nanostructured (nanoparticulated) Telmisartan compositions, process for the preparation thereof and pharmaceutical compositions containing them. The nanoparticles of Telmisartan according to the invention have an average particle size of less than about 600 nm. Telmisartan is an angiotensin II receptor antagonist (ARB) used in the management of hypertension.

Abstract: Cationic poly(ester ether amide)s (PEEAs) and compositions comprising PEEAs and biomolecules such as nucleic acids and proteins. Also, a method for intracellular delivery of biomolecules using complexes of the PEEAs and biomolecules. For example, PEEAs can be used as transfection agents for nucleic acids such as DNA and RNA.

Abstract: A dpi formulation comprises a solvate of beclomethasone and is substantially free of excipient and free of carrier. The solvate particles are of size 0.5 to 10 microns and are obtained by crystallization of the steroid in the presence of ultrasound.

Abstract: A personal care product comprises an antiperspirant product housed within a container. The antiperspirant product comprises a first portion comprising a first ingredient. A second portion is macroscopically separated from the first portion. The second portion has a composition different from the first portion and comprises a second ingredient effective to interact with the first ingredient to produce a predetermined effect.

Abstract: A personal care product comprises an antiperspirant product that is housed within a container. The antiperspirant product comprises a dispersed cooling sensation agent that is adsorbed onto surfaces of silica particles that are dispersed throughout the antiperspirant product, absorbed into pores of the silica particles or a combination thereof.

Abstract: The invention provides process for making contra-soluble nano-dispersions of at most sparingly-soluble materials in a soluble carrier material comprising the steps of: (i) providing a single phase mixture of: (a) a solvent or a mixture of miscible solvents wherein at least one of the solvents is an aqueous solvent and at least another solvent is a non-aqueous solvent, (b) at least one carrier material soluble in solvent (a), said carrier material being also contra-soluble to payload material (c) and solid at ambient temperature, (c) at least one a payload material which is soluble in solvent (a), and, (ii) freeze-drying the mixture to remove solvent (a) and thereby obtain the carrier material (b) in solid form with payload (c) dispersed therein as nanoparticles.

Abstract: Object of the present invention is to provide a preparation for oral cavity that is appropriately usable as a prophylactic agent for dental caries, a therapeutic agent for dental caries at early stage, a prophylactic and/or therapeutic agent for dentinal hypersensitivity, a preparation for the lining of a dentin cavity surface, or the like, which has a superior effect of sealing the dentinal tubules, is capable of improving the acid resistance of the teeth and re-calcifying the teeth, ensures a short-time treatment with an easy operation, and has a high safety and good aesthetic properties.

Abstract: Provided herein are biocidic compositions including an ion exchange material, wherein when said material is in an environment capable of transporting H+, said ion exchange material is adapted to cause the death of at least one cell within or in contact with said environment. A selectively permeable barrier layer may be provided covering the ion exchange material. Also provided herein are methods of making the foregoing biocidic compositions. In addition, provided herein are methods of using the foregoing biocidic compositions to cause the death of at least one cell.

Abstract: This invention is in the field of controlled elution devices for therapeutic delivery. There exists a need for a stand-alone capable device for the localized and extended delivery of a therapeutic. This need is overcome by the present invention having an exemplary embodiment comprised of a microfilm base (12), a reservoir of a therapeutic (14) disposed about the microfilm base (12) and a top layer (24) that is (i) a plurality of laminated layers (24) of para-xylyelne polymer and/or (ii) para-xylyelne polymer endowed with oxidatively functionalized para-xyele units. The thicknesses of the device is optimally in the range of about 10 to about 200 microns. The device is usable for the localized release of broad spectrum therapeutics for interventional and preventative medicine.

Abstract: A wound dressing material comprising: a wound dressing carrier, N-acetyl cysteine or a salt or derivative thereof, and a stabilized ascorbate. Suitably, the stabilized ascorbate comprises an ascorbate-2-polyphosphate. Also provided are wound dressing comprising the materials, methods of treatment with the materials, and methods of making the materials.

Abstract: An object of the present invention is to provide a uronic acid-containing glucan or a modified product thereof. The glucuronic acid-containing glucan of the present invention is a glucuronic acid-containing glucan in which a glucuronic acid residue is bound to at least one non-reducing end of a glucan, and the glucan is a branched ?-1,4 glucan or a linear ?-1,4 glucan. The glucuronic acid-containing glucan of the present invention can be provided by allowing ?-glucan phosphorylase derived from Aquifex aeolicus VF5 to act on glucuronic acid-1-phosphate to thereby transfer a glucuronic acid residue to the non-reducing end of the receptor glucan.