Abstract: A lipoprotein lipase (LPL) protein for treating and/or preventing HTG and its associated diseases, including but not limited to acute pancreatitis (AP), and in particular, acute pancreatitis secondary to or exacerbated by hypertriglyceridemia, and hypertriglyceridemia and its associated diseases in general, including cardiovascular and metabolic diseases, endocrine disorders, and fat embolism syndrome.

Abstract: The present invention provides methods of treating LAL deficiency comprising administering to a mammal a therapeutically effective amount of lysosomal acid lipase with an effective dosage frequency. Methods of improving growth and liver function, increasing LAL tissue concentration, and increasing LAL activity in a human patient suffering from LAL deficiency are also provided.

Abstract: The present technology relates generally to formulations comprising egg white protein, methods of manufacturing egg protein formulations and uses for egg protein formulations. In particular, several embodiments are directed to egg protein formulations for oral administration in immunotherapy of subjects affected by egg allergies.

Abstract: The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated form of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.

Abstract: The present invention is directed to compounds, methods for stabilizing thrombin activity with a thrombin binding oligonucleotide and to stabilized thrombin. The thrombin binding oligonucleotide is capable of inhibiting thrombin activity whereby the inhibition can be reversed with an antisense oligonucleotide.

Abstract: The invention relates to systems and therapeutic methods to reduce plaque causing Peyronie's disease. One approach uses high pressure injection of collagenase-containing composition into a penile plaque. Plaque disruption is enhanced by the mechanical force of the high pressure, followed by the enzymatic action of collagenase. Another approach uses collagenase as a pretreatment, followed by addition of adipose-derived stem cells ADSCs. The initial collagenase injection breaks down collagen (often more type III than type I in Peyronie's) to provide short term benefit. The longer-term benefit is provided by introduction of ADSCs to the plaque, which can produce cytokines and other signals for revascularization, and restoration of normal penile tissue. The resulting combination advantageously reduces the bulk of the plaque early on with ongoing reduction through the revascularization of the tissue. In addition, the treatment provides an advantageous shift of elastin and collagen ratios.

Abstract: The invention provides methods for treating primary disorders of mood and affect, including depressive disorders, anxiety and sleep disorders and CNS disorders comprising the administration of a neurotoxin.

Abstract: The present invention relates to the isolation of polypeptides derived from the Clostridium botulinum neurotoxin and the use thereof as treatment for neuronal injury such as spinal cord injury. Botulinum neurotoxin binds to neural cells and are translocated into the cytosol and therefore is useful as a target specific therapeutic delivery system. Non-toxic botulinum toxin may be created by light chain mutagenesis and/or removal of the endopeptidase domain.

Abstract: Methods of using botulinum toxin based pharmaceuticals are disclosed. The methods cause vasodilatation and decreased flow resistance of certain vascular beds for the purpose of increasing blood flow to a region in order to positively impact deterioration from a number of diseases.

Abstract: Improved formulations for transdermal delivery of botulinum toxin are disclosed. The formulations include, for example, botulinum toxin non-covalently associated with a positively charged backbone having branching or efficiency groups. The formulations also include a partitioning agent, oligo-bridge, or polyanion bridge, and may optionally contain a viscosity modifying agent. The formulations are designed for topical application onto the skin of a patient and may be used to treat wrinkles, hyperhidrosis, and other health-related problems. Kits for administration are also described.

Abstract: Oxalate decarboxylase crystals, including stabilized crystals, such as cross-linked crystals of oxalate decarboxylase, are disclosed. Methods to treat a disorder associated with elevated oxalate concentration using oxalate decarboxylase crystals are also disclosed. Additionally disclosed are methods of producing protein crystals.

Abstract: Provided herein are improved compositions and methods for enzyme replacement therapy using modified human cystathionine beta synthase (CBS) in the treatment of homocystinuria and related diseases and disorders.

Abstract: The present invention generally relates to the fields of parasitology and immunology, and especially to a vaccine against Rhipicephalus ticks. In particular the invention relates to a composition comprising a first and a second protein, in particular Bm86 and Subolesin proteins, including their homologs or immunogenic fragments; to the use of such a composition as a vaccine against Rhipicephalus ticks, and to the use of the first and the second isolated proteins for the vaccination of a target against Rhipicephalus ticks.

Abstract: The present invention provides an immunogenic composition comprising a nucleic acid that comprises a sequence encoding a cat telomerase deprived of telomerase catalytic activity, or a fragment thereof.

Abstract: The invention provides compositions and methods for treating diseases associated with expression of CLL-1. The invention also relates to chimeric antigen receptor (CAR) specific to CLL-1, vectors encoding the same, and recombinant cells comprising the CLL-1 CAR. The invention also includes methods of administering a genetically modified cell expressing a CAR that comprises a CLL-1 binding domain.

Abstract: The present invention provides a method for detecting cancer using a protein expressed in various cancers, and a pharmaceutical composition for the treatment or prevention of such cancer using the protein as an indicator. Furthermore, the present invention provides a pharmaceutical composition containing a cancer antigen peptide derived from the protein. More particularly, the method comprises the step of determining the presence or amount of an eEF2 polypeptide or an eEF2 antibody in a sample obtained from a subject.

Abstract: In one aspect, the present invention provides a method for treating cancer comprising tumor cell vaccination in combination with hematopoietic and immune cell transplantation. In some embodiments, the method involves autologous tumor cell vaccination prior to autologous hematopoietic and immune cell transplantation. In another aspect, the present invention provides a method of purifying tumor cells from a subject in preparation for vaccination.

Abstract: The present invention relates to peptides, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumour-associated T-helper cell peptide epitopes, alone or in combination with other tumour-associated peptides that serve as active pharmaceutical ingredients of vaccine compositions which stimulate anti-tumour immune responses. The present invention relates to novel peptide sequences and their variants derived from HLA class I and class II molecules of human tumour cells which can be used in vaccine compositions for eliciting anti-tumour immune responses.

Abstract: The present invention provides isolated polypeptides isolatable from a Yersinia spp. Also provided by the present invention are compositions that include one or more of the polypeptides, and methods for making and methods for using the polypeptides.

Abstract: Herein a Bacillus exosporium antigen delivery (BEAD) system that provides a means to introduce recombinant proteins or small molecules into the exosporium of members of the B. cereus family of bacteria, i.e. B. anthracis, B. cereus, and B. thuringiensis, is disclosed. The system results in the surface display of recombinant proteins or small molecules such that they can stimulate an immune response. In addition, methods of making and using the system are described.

Abstract: The invention relates to vaccines for treating prostate inflammation and benign prostate hyperplasias (stages I and II) comprising Lactobacillus strains in an inactivated form and carriers and/or excipients commonly used in vaccine preparations.

Abstract: This invention provides, among other things, proteins, polypeptides, and fragments thereof, derived from the bacteria Neisseria meningitidis B. Also provided are nucleic acids encoding for such proteins, polypeptides, and/or fragments, as well as nucleic acids complementary thereto e.g., antisense nucleic acids). Additionally, this invention provides antibodies which bind to the proteins, polypeptides, and/or fragments. This invention further provides expression vectors useful for making the proteins, polypeptides, and/or fragments, as well as host cells transformed with such vectors. This invention also provides compositions of the proteins, polypeptides, fragments, and/or nucleic acids, for use as vaccines, diagnostic reagents, immunogenic compositions, and the like. Methods of making the compositions and methods of treatment with the compositions are also provided. This invention also provides methods of detecting the proteins, polypeptides, fragments, and/or nucleic acids.

Abstract: A synthetic, codon-optimized Hantaan virus (HTNV) full-length M gene open reading frame that consists of a unique nucleotide sequence encoding HTNV proteins. This synthetic gene was cloned into a plasmid to form the first optimized HTNV full-length M gene that elicits neutralizing antibodies in animals when delivered in combination with a similarly optimized Puumala virus (PUUV) DNA vaccine. The invention obviates the need for an extraneous gene sequence that was previously required for expression of the non-optimized HTNV gene. The synthetic gene is engineered into a molecular vaccine system to prevent hemorrhagic fever with renal syndrome (HFRS) caused by infection with HTNV, SEOV, or DOBV. Alternatively, it can be combined with the optimized PUUV DNA vaccine to protect against HFRS caused by any hantavirus.

Abstract: Methods and compositions for the optimization of production of influenza viruses suitable as influenza vaccines are provided.

Abstract: The invention provides an aqueous acidic formulation suitable for use as in the preparation of a pharmaceutically acceptable fluorocarbon-linked peptide formulation, which aqueous formulation comprises a first fluorocarbon-linked peptide, wherein: the peptide linked to the fluorocarbon is at least 20 amino acid residues long, comprises at least 50% hydrophobic amino acid residues and has an isoelectric point greater than or equal to 7; and the fluorocarbon-linked peptide is present in micelles.

Abstract: The invention provides an isolated H3 equine influenza A virus, as well as methods of preparing and using the virus, and genes or proteins thereof.

Abstract: Methods for detection of canine herpes virus 1 (CHV-1) in archived paraffin-embedded tissue are provided. The methods use CHV-1 glycoprotein B (gB)-specific PCR to detect the CHV-1. A vaginal sleeve that protects puppies from contracting CHV-1 by contact with the mother's vaginal wall during birth is also provided. The sleeve is inserted into the vagina of a pregnant female dog prior to birth and puppies traverse the birth canal through the sleeve without coming into direct contact with vaginal tissue. Compositions and methods of immunizing against CHV-1 in dogs of all ages are also provided.

Abstract: The invention provides a recombinant polynucleotide comprising a truncated glyceraldehyde-3-phosphate dehydrogenase (gpd) promoter and a modified HBV S protein gene and a transgenic Flammulina velutipes carrying the recombinant polynucleotide. The invention surprisingly found that after administering the transgenic Flammulina velutipes to a subject, the subject can successfully generate an antibody against HBV. Therefore, the transgenic Flammulina velutipes can be used as a vaccine against HBV.

Abstract: Provided are methods and compositions that can be used to treat subjects having a viral infection by provoking an immune response using newly discovered antigens that are non-naturally occurring variations on viral glycoproteins. For example, provided are viral glycoproteins or a fragments thereof, or, DNA constructs encoding for such viral glycoproteins or fragments thereof, wherein the glycoprotein or fragment comprises a glycosylation sequon that includes a non-templated aspartic acid residue.

Abstract: Methods for treatment of a Type I allergy in a mammal comprise administering to an individual in need of such treatment a polypeptide of SEQ ID NO: 1 or the mature protein, amino acids 25-260, of the polypeptide of SEQ ID NO: 1, or a fragment of the polypeptide or the mature protein, which fragment shares epitopes for antibodies with the polypeptide or the mature protein, respectively, or a hypoallergenic form thereof that is modified to abrogate or attenuate its IgE binding response. Diagnostic kits comprise the polypeptide of SEQ ID NO: 1 or the mature protein, amino acids 25-260, of the polypeptide of SEQ ID NO: 1, immobilized on a solid support.

Abstract: The invention provides a process for preparing a conjugate of a S. aureus type 8 capsular polysaccharide and a carrier molecule, comprising the steps of: (a) depolymerising the capsular polysaccharide, to give a polysaccharide fragment; (b) oxidising the fragment in order to introduce an aldehyde group into at least one saccharide residue in the fragment, to give an oxidised saccharide residue; and (c) coupling the oxidised saccharide residue to a carrier molecule via the aldehyde group, thereby giving the conjugate. The coupling in step (c) may be direct, or may be via a linker molecule. The invention also provides a conjugate obtained or obtainable by this process.

Abstract: A method is provided for increasing an immunological response to a target antigen in an animal by administering an immunogenic amount of a vaccine comprising a polypeptide conjugate comprising the target antigen conjugated to a carrier polypeptide by means of a linker polypeptide which is rich in predicted linear B-cell epitopes.

Abstract: It has been discovered that PIK3? (PIK3delta) selectively modulates the activation and proliferation of natural Tregs. Methods of modulating immune responses by modulating PIK3? bioavailability or biological activity are provided.

Abstract: An improved method for preparing squalene from a squalene-containing composition, said method comprising the steps of (a) a purification distillation carried out at a temperature T1 (b) a denaturing distillation carried out at a temperature T2; wherein steps (a) and (b) may be performed in either order; T1 and T2 are sufficient to cause squalene to boil; T2>T1; and T2>200° C.

Abstract: The invention relates to novel combination therapies involving BLyS or BLyS/APRIL inhibition and anti-CD20 agents for the treatment of autoimmune diseases. One preferred method is where the BLyS antagonist is a Fc-fusion protein which can be a TACI-Fc-fusion protein comprising the extracellular domain of TACI or a functional fragment thereof, a BAFF-R-Fc-fusion protein comprising the extracellular domain of BAFF-R or a functional fragment thereof, or a BCMA-Fc-fusion protein comprising the extracellular domain of BCMA or a functional fragment thereof. In the methods of the present invention some of anti-CD20 agents contemplated include RITUXAN®, ocrelizumab, ofatumumab (HuMax-CD20®), TRU-015, and DXL625, although any agent that binds to CD 20 may be suitable. The methods of the present invention reduce the levels of B cells in patients in need of such reduction, such as those suffering from autoimmune diseases.

Abstract: This application provides a method of treating cancer in a patient comprising administering at least one dose of radiation therapy and at least one PD-1 and/or PD-L1 antagonist, wherein at least one PD-1 and/or PD-L1 antagonist is administered on the same day as a dose of radiation therapy or up to and including 4 days later.

Abstract: The disclosure features compositions and methods for increasing the half-life of a therapeutic agent (e.g., a C5 antagonist) in the serum of a subject (e.g., a human). Also featured are compositions and methods for: (i) decreasing the frequency by which a therapeutically effective amount of a therapeutic agent must be administered to a human having, suspected of having, or at risk for developing, a medical condition for which the therapeutic agent is effective and (ii) decreasing the dosage of the therapeutic agent required for therapeutic efficacy in a human having, suspected of having, or at risk for developing, a medical condition for which the therapeutic agent is effective. The methods include reducing the serum concentration of the antigen to which the therapeutic agent binds.

Abstract: The present invention relates to methods and pharmaceutical compositions for inhibiting lymphocyte proliferationin a subject in need thereof. In particular, the invention relates to a CTP synthase 1 (CTPS1) inhibitor for use in a method for inhibiting lymphocyte proliferationin a subject in need thereof. The invention also relates to a method for screening a plurality of test substances useful for inhibiting lymphocyte proliferationin a subject in need thereof comprising the steps consisting of i) testing each of the test substances for its ability to inhibit CTPS1 activity or expression and ii) identifying the test substance which inhibits CTPS1 activity or expression thereby to identify a test substance useful for inhibiting lymphocyte proliferationin a subject in need thereof.

Abstract: Methods of evaluating patients by assessing expression of B7-H4 in the vasculature are described.

Abstract: A porphyrin of general formula (I) having a transition metal (II) cation in its core and one or two mono-, di-, tri-, tetra- or penta-halophenyl groups and two or three pyridyl groups in the 5, 10, and/or 15 positions of the porphyrin ring contributing to a positive two or three charge neutralized by the presence of a respective number of anions. The porphyrin of the general formula (I) characterized by killing pseudomonas bacteria in the dark.

Abstract: The present invention relates to processes for purifying high-quality recombinant Plasmodium falciparum circumsporozoite protein at high yields.

Abstract: Low melting propionic acid derivative particles that are free flowing and have significantly reduced or eliminated throat burn are disclosed. A method of manufacturing the low melting propionic acid derivative particles; dosage forms containing the low melting propionic acid derivative particles; methods of manufacturing the dosage forms; and methods of treatment using the dosage forms are also disclosed.

Abstract: The invention provides stable formulations of pemetrexed for infusion. The formulations are based on using pemetrexed diacid and certain selected suitable stabilising basic amine compounds that provide counter ions to the pemetrexed diacid, forming base addition salts. The formulations can be dried powder formulations to be reconstituted as liquid concentrate formulations or directly in ready-to-use infusion solutions, or they can be liquid formulations, most suitably concentrates to be diluted in infusion solution prior to use. The suitable basic amine addition compounds according to the invention are one or more of diethanolamine, tris-(hydroxymethyl)aminomethane and meglumine.

Abstract: The present invention comprises a co-processed carbohydrate system, and formulations produced therefrom, which formulations are directly compressible into solid dosage forms, some of which rapidly and completely dissolve or disintegrate in the oral cavity within 60 seconds. The invention also comprises the solid dosage forms produced by directly compressing the co-processed carbohydrate system, some of which, when placed in the oral cavity, shall dissolve or disintegrate, preferably within about 60 seconds.

Abstract: The present disclosure refers to transdermal pharmaceutical bases that include a synergistic combination of a silicone base with a natural permeation enhancement composition (NPE). Further, these transdermal pharmaceutical bases are proposed to treat ear diseases in mammals The silicone base includes silicone, pracaxi oil, and seje oil. Additionally, the NPE composition includes one or more phospholipids, one or more oils rich in essential fatty acids, behenic acid, and oleic acid, one or more skin lipids, and one or more butters rich in linoleic acid and linolenic acid. The synergistic combination of aforementioned natural components exhibit enhanced healing properties, thereby providing organic acids with antioxidant, antibacterial, and antifungal properties. The transdermal pharmaceutical bases are employed to increase the residence time of the medicament in the ear canal, and increase the penetration of the APIs into the affected area, thereby enhancing treatment effectiveness.

Abstract: The invention relates in one aspect to acomposition, specifically a jelly, the use of which composition as an auxiliary means is to ease the taking of oral medication in solid form, which composition comprises iota-carrageenan as a jellifying agent and citric acid as a salivating agent, characterized in that the composition further comprises maltodextrin. In another aspect, the composition comprises a calcium sequestrant for adjusting Ca-ion activity of the composition. In one embodiment, the composition comprises iota-carrageenan in 0.7-1.0% in mass, citric acid in 0.06-0.07% in mass, maltodextrin in 1.5% in mass, all relative to the total mass of the composition, and an amount of a calcium sequestrant such that the Ca-ion activity of the composition is between 20 ppm and 80 ppm.

Abstract: Excipient compositions including a combination of excipients for mucoadhesive pharmaceutical compositions that improve mucoadhesiveness power, as well as release of and adhesion time of suitable active pharmaceutical ingredients (APIs) are disclosed. The excipient compositions include an aqueous solution with a synergistic combination of polymers, such as, for example amylopectin, pullulan, hyaluronic acid, and tamarind xyloglucan, among others. These polymers have been demonstrated to improve the release of as well as the adhesion time of APIs onto mucosa membrane. Mucoadhesive pharmaceutical compositions that include excipient compositions include suitable APIs, such as, for example analgesics, anesthetics, anthelmintics, anti-allergic agents, anti-fungals, antihistamines, anti-inflammatory agents, antimigraine agents, and hormones, among others. Mucoadhesive pharmaceutical compositions including excipient compositions are employed in the treatment of a plurality of mucous membrane diseases.

Abstract: The present disclosure refers to a synergistic blend of Konjac powder and Xanthan gum that is included, as a natural suspending agent, in oral pharmaceutical suspensions. Oral pharmaceutical suspensions comprising the synergistic blend are aqueous solutions. The synergistic blend, used as a suspension agent to suspend suitable active pharmaceutical ingredients (APIs), improves the stability of oral pharmaceutical suspensions, and helps in the formation of a thermo-reversible gel and shear thinning necessary to keep APIs suspended within oral pharmaceutical suspensions. The synergistic blend of Konjac powder and Xanthan gum has unique anti-flocculation properties, which improve the homogeneity of the oral pharmaceutical suspensions. Additionally, the blend provides a better texture and mouth feel.

Abstract: A 5?-androstane-3?,5,6?-triol injection and its preparation are disclosed. The injection uses hydroxypropyl-?-cyclodextrin as a solubilizing agent and the active ingredient is present at a weight ratio of 1-20:40-500 to the hydroxypropyl-?-cyclodextrin. The injection may also comprise, by weight, 1-100 parts of at least one isotonic adjusting agent, 0-200 parts of at least one freeze drying filler, and 0-2000 parts of at least one solvent. The preparation method comprises dissolving hydroxypropyl-?-cyclodextrin solution, 5?-androstane-3?,5,6?-triol and at least one additional soluble excipient in water for injection in sequence to obtain a raw injection solution, and subjecting the raw injection solution to decolorization, depyrogenation, filtration and sterilization to obtain the injection. Drying the filtrate yields a solid for injection.

Abstract: The present disclosure relates to pharmaceutical compositions with increased skin permeability for treating ear disease in mammals Disclosed pharmaceutical compositions are prepared as topical gels or as transdermal gels. The pharmaceutical compositions reduce ear inflammation and irritation produced by ear diseases or injuries (e.g., cauliflower ear, chronic otitis, and the like). The pharmaceutical compositions include a synergistic combination of pracaxi oil and seje oil. Additionally, the pharmaceutical compositions include phosphatidylcholine as a permeation enhancer. The combination of aforementioned natural components exhibits enhanced healing properties, thereby providing organic acids with antioxidant, antibacterial, and antifungal properties.