Abstract: A method of treating a cancer of the central nervous system in a subject in need thereof is provided. The method comprising administering to the subject a therapeutically effective amount of an agent which reduces blood glutamate levels and enhances brain to blood glutamate efflux to thereby treat the cancer of the central nervous system in the subject.

Abstract: Described herein are variant, recombinant ?-glucocerebrosidase proteins characterized as having increased stability relative to recombinant wild-type ?-glucocerebrosidase. Also provided herein are variant, recombinant ?-glucocerebrosidase proteins characterized as retaining more catalytic activity relative to recombinant wild-type ?-glucocerebrosidase. Further described herein are variant, recombinant ?-glucocerebrosidase proteins that can have amino acid variations at one or more of the following positions: 316, 317, 321 and 145. Methods of making the variant, recombinant ?-glucocerebrosidase proteins are also described as well as methods of treating patients having lysosomal storage diseases.

Abstract: A stable pharmaceutical composition in liquid form or in solid form, comprising factor VII, said composition being free of mannitol and of sucrose, or even also of any antioxidant.

Abstract: Ophthalmic conditions such as presbyopia, myopia, and astigmatism can be corrected by the use of a molding contact lens in combination with a pharmaceutical composition suitable for delivery to the eye. The molding contact lenses are preferably commercially available and are not specifically designed for orthokeratology. The agents in the pharmaceutical compositions such as hyaluronase allow the cornea of the eye to be molded in order to correct the refractive error of the eye. The contact lenses and the pharmaceutical composition induce a change in the radius of curvature of the anterior surface of the cornea, thereby correcting the refractive error of the eye. One advantage of the inventive technique is that the patient with his or her own individual visual needs guides the treatment until the patient near and far visual needs are met.

Abstract: Methods for treating skin disorders by local administration of a Clostridial toxin, such as a botulinum toxin, to a patient with a skin disorder.

Abstract: Vaccines comprising TRAP polypeptides and Salmonella enteritidis vectors comprising TRAP polypeptides are provided. The vaccines may also include a CD 154polypeptide capable of binding to CD40. Also provided are methods of enhancing an immune response against Apicomplexan parasites and methods of reducing morbidity associated with infection with Apicomplexan parasites.

Abstract: Disclosed are immunomodulatory agents that are useful for treating or preventing joint damage. More particularly, immunomodulators are disclosed for use in eliciting an antigen-specific tolerogenic response to an aggrecan polypeptide including citrullinated forms thereof to treat or prevent joint damage, including joint damage in subjects with early RA or incipient RA.

Abstract: Peptides and vaccine compositions comprising peptides based upon EGFRvIII and lacking a glycine at the splice junction are disclosed. The vaccines can induce immune responses against EGFRvIII. Methods of inhibiting formation or growth of EGFvIII tumors, methods of inducing regression of EGFvIII tumors, methods of immunizing against EGFvIII tumors and methods of treating a subjects who have EGFvIII tumors are disclosed.

Abstract: The present invention discloses methods of stimulating an immune response to cancer tissue and biological effectors used by tumors to defeat the host, through the immunization of a mammal using placental tissue, cells, molecules, and combinations thereof. In one embodiment, the invention provides the utilization of syngeneic, allogeneic, xenogeneic, and combinations thereof as immunizing sources.

Abstract: A composition for treating cancer, comprising 6 to 13 peptides derived from tumor antigens, wherein the composition is used in the manner that antibodies to the respective peptides in the peripheral blood of a patient are measured and peptides to which antibodies are positive are selected and administered to the patient, and a peptide selection method.

Abstract: Bacterial live vector vaccines represent a vaccine development strategy that offers exceptional flexibility. In the present invention, genes encoding protective antigens of unrelated bacterial, viral, parasitic, or fungal pathogens are expressed in an attenuated bacterial vaccine strain that delivers these foreign antigens to the immune system, thereby eliciting relevant immune responses. Rather than expressing these antigens using only low copy expression plasmids, expression of foreign proteins is accomplished using both low copy expression plasmids in conjunction with chromosomal integrations within the same live vector. This strategy compensates for the inherent disadvantage of loss of gene dosage (versus exclusive plasmid-based expression) by integrating antigen expression cassettes into multiple chromosomal sites already inactivated in an attenuated vector.

Abstract: The present invention relates to Neisseria ORF2086 proteins, crossreactive immunogenic proteins which can be isolated from nesserial strains or prepared recombinantly, including immunogenic portions thereof, biological equivalents thereof, antibodies that immunospecifically bind to the foregoing and nucleic acid sequences encoding each of the foregoing, as well as the use of same in immunogenic compositions that are effective against infection by Neisseria meningitidis serogroup B.

Abstract: A method of producing a virus-like particle (VLP) in a plant is provided. The method comprises introducing a first nucleic acid into the plant, or portion of the plant. The first nucleic acid comprising a first regulatory region active in the plant operatively linked to a nucleotide sequence encoding one or more rotavirus structural protein for example but not limited to rotavirus protein VP2. The nucleotide sequence may further comprise one or more than one amplification element and/or a compartment targeting sequence. A second nucleic acid might be introduced into the plant, or portion of the plant. The second nucleic acid comprises a second regulatory region active in the plant and operatively linked to a nucleotide sequence encoding one or more rotavirus structural protein, for example but not limited to rotavirus protein VP6. Optionally, a third nucleic acid and/or fourth nucleic acid might be introduced into the plant, or portion of the plant.

Abstract: The present invention relates to a methodology for the generation of infectious ribonucleoparticles (RNPs) of negative-strand RNA viruses, and in particular of non-segmented negative-strand RNA viruses in yeast, especially in budding yeast. Accordingly, the patent application relates to a recombinant yeast strain suitable for the rescue of infectious non-segmented negative-strand RNA virus particles or infectious virus-like particles. The invention also relates to the use of the recombinant yeast to prepare vaccine seed and to the use of the produced RNPs or RNPs-like to prepare vaccine formulations. It also concerns the use of the recombinant yeast for the screening of libraries of DNA.

Abstract: The subject of the invention is a method for purifying the rabies virus, comprising a single ion-exchange chromatography step, said step being cation exchange chromatography according to which: a) the supernatant of a culture of cells infected with this virus is brought into contact with a cation exchange chromatography support comprising a polymethacrylate matrix onto which sulfoisobutyl groups have been grafted such that the rabies virus binds to this support, and; b) the virus is eluted from its support.

Abstract: This disclosure provides an attenuated palmiped parvovirus that affords heterologous protection for both Muscovy duck parvovirus and goose parvovirus (i.e., Derzsy's Disease). The disclosure further provides compositions comprising the same, and methods of production and use thereof.

Abstract: In one embodiment, an expression system for expressing a UL128 complex is provided herein. The expression system may include a bacterial artificial chromosome (BAC) construct, wherein the BAC construct comprises a viral vector inserted with a set of DNA sequences that encode a UL128 complex. In another embodiment, a vaccine composition for preventing HCMV infection is provided. The vaccine composition may include a viral or bacterial vector capable of expressing a UL128 complex and a pharmaceutically acceptable carrier, adjuvant, additive or combination thereof or additional vector expressing a protein adjuvant. The viral vector may be an MVA and the UL128 complex includes five HCMV proteins or antigenic fragments thereof: UL128, UL130, UL131A, gL, and gH. In some embodiments, the viral vector is further inserted with one or more additional DNA sequences that encode one or more additional HCMVHCMV proteins or antigenic fragments thereof such as pp65, gB or both, or such as gM/gN or gO.

Abstract: The present invention relates to methods of inducing or enhancing an immune response against an immunogen in a subject. The invention further includes isolated nucleic acid vaccines, cellular vaccines, fusion proteins, expression vectors, vaccines, and immunogenic compositions for use therein.

Abstract: The invention discloses pharmaceutical compositions in liquid form comprising a peptide with the amino acid sequence KLKL5KLK and an oligodeoxynucleotide with the nucleic acid sequence (dIdC)13 and wherein the peptide and the oligodeoxynucleotide are present as sterile-filterable nanoparticles in the composition, thereby forming a suspension, characterized in that the mean particle size of the solid particles is less than 1 ?m.

Abstract: This invention describes novel adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37° C. that can be produced at remarkably low costs. This invention describes novel vaccine compositions and formulations to treat and prevent urinary tract infections caused by gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli. This invention also describes methods of administration of said novel vaccine compositions and formulations and methods of treatment to prevent and treat urinary tract infections caused by gram-negative bacteria including E. coli and multi-drug resistant E. coli.

Abstract: This invention describes novel adjuvant compositions and formulations with excellent stability at refrigerated and room temperatures and up to and about 37° C. that can be produced at remarkably low costs. This invention describes novel vaccine compositions and formulations to treat and prevent urinary tract infections caused by gram-negative bacteria including Escherichia coli and multi-drug resistant E. coli. This invention also describes methods of administration of said novel vaccine compositions and formulations and methods of treatment to prevent and treat urinary tract infections caused by gram-negative bacteria including E. coli and multi-drug resistant E. coli.

Abstract: The present invention describes combination treatment comprising a PD-1 axis binding antagonist and an agent that decreases or inhibits TIGIT expression and/or activity and methods for use thereof, including methods of treating conditions where enhanced immunogenicity is desired such as increasing tumor immunogenicity for the treatment of cancer or chronic infection.

Abstract: It has been discovered that administering therapeutically effective amounts of an antibiotic that kills Gram-negative bacteria, together with an anti-ceramide antibody or anti-ceramide mimetic, treats and prevents an array of diseases mediated by cytolytic T lymphocyte (CTL)-induced killing and/or by damage to endothelial microvasculature, including Radiation GI syndrome, CGvHD disease, inflammatory diseases and autoimmune diseases.

Abstract: Pharmaceutical composition including a bispecific anti-c-Met/anti-EGFR antibody and a c-Src inhibitor and a method of preventing and/or treating cancer including co-administering a bispecific anti-c-Met/anti-EGFR antibody and a c-Src inhibitor to a subject in need thereof.

Abstract: An immune response against an antigen is induced by stimulation with a two-component vaccine that includes an antiidiotypic antibody as one of the components. An immune response against an antigen is also induced by stimulation with other two-component vaccines. Stimulation by a two-component vaccine may be followed by stimulation with a monoclonal broadly neutralizing anti-HIV antibody or with one of the components of the two-component vaccine. This method of inducing immunity has applications in vaccines against infectious pathogens and in therapeutic and preventive vaccines against cancers.

Abstract: The present invention provides methods and compositions of enhancing the immune response to an antigen.

Abstract: Various embodiments of the present invention provide therapeutic compositions for specifically targeting tumor cells. In some embodiments, the therapeutic compositions generally include: (1) a plurality of nanovectors; (2) one or more active agents associated with the nanovectors, where the one or more active agents have activity against the tumor cells; (3) one or more active agent enhancers associated with the nanovectors; and (4) one or more targeting agents associated with the nanovectors, where the one or more targeting agents have recognition activity for one or more markers of the tumor cells. Additional embodiments of the present invention pertain to methods of targeting tumor cells in a subject by administering one or more of the aforementioned therapeutic compositions to the subject. Further embodiments of the present invention pertain to methods of formulating the aforementioned therapeutic compositions for targeting tumor cells in a subject in a personalized manner.

Abstract: The present invention pertains to a composition containing an immunogenic cell preparation of killed Leptospira bacteria in a citric acid solution. It also pertains to a vaccine to protect an animal against an infection with Leptospira bacteria, wherein the vaccine comprises this composition, and to the use of citric acid to stabilise an immunogenic preparation of killed Leptospira bacteria in a liquid carrier, by dissolving the citric acid in the carrier.

Abstract: A storage-stable pharmaceutical composition includes an aqueous solution of at least an antibody-derived therapeutically active protein chosen amongst antibody, nanobody or fusion protein and an amount effective to stabilize the antibody-derived therapeutically active protein of at least one lauryldimethylamineoxide and/or of one of its amine oxide analogs.

Abstract: A method is disclosed of using an inhibitor of a carboxylesterase and a drug in an animal, wherein the inhibited carboxylesterase reduced the efficacy of the drug in the animal.

Abstract: The present invention relates to an aqueous composition comprising: (i) a quaternary ammonium neuromuscular blocking agent; and (ii) an excipient selected from a polyhydroxy acid of the following formula: HO—CH2—[CH(OH)]n—COOH, wherein n is an integer from 1 to 8, an intramolecular lactone of said polyhydroxy acid or a mixture thereof.

Abstract: The present invention relates to alkylglycoside-containing compositions and methods for increasing the stability, reducing the aggregation and immunogenicity, increasing the biological activity, and reducing or preventing fibrillar formation of a peptide, polypeptide, or variant thereof, for example parathyroid hormone (PTH) or PTH analogs, amylin, a monoclonal antibody, insulin, Peptide T or analog thereof, gastrin, gastrin releasing peptides, gastrin releasing peptide-like (GRP) proteins, epidermal growth factor or analog thereof.

Abstract: Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives are disclosed.

Abstract: The present invention relates to compositions and methods comprising resveratrol and uses thereof. Some embodiments include compositions and methods with increased bioavailability of resveratrol. Certain embodiments include compositions comprising resveratrol and a solubilizer. Particular embodiments include transmucosal delivery of resveratrol from the composition.

Abstract: The present invention provides long-term stable pharmaceutical formulations of recombinant von-Willebrand Factor (rVWF) and methods for making and administering said formulations.

Abstract: Disclosed is a hair care composition comprising polyquaternium-6 and metal pyrithiones as antidandruff agents, wherein the composition is substantially free of glucan gum, nonionic guar gum and hydroxyethylcellulose. The composition of the present invention provides improved deposition of antidandruff agents such as zinc pyrithione on scalp.

Abstract: Provided herein in some embodiments is a composition that comprises (a) a nanoscale particle(s) or a microscale particle(s); and (b) a film-forming polymer. Also provided herein is a method for an immediate and sustained released formulation suitable for topical administration or administration to surfaces. Further provided herein in certain embodiments is a method of reducing the population of pathogenic microorganisms on skin or surfaces, wherein a method comprises applying to the skin or surface a composition, wherein the composition comprises (a) a nanoscale particle(s) or a microscale particle(s); and (b) a film-forming polymer.

Abstract: The present invention relates to a pharmaceutical composition for topical application for the treatment of alopecia, said composition comprising polymeric nanoparticles, preferably nanocapsules containing two active ingredients, finasteride and minoxidil, additives and a pharmaceutically acceptable carrier. The invention further includes a process for the preparation of polymeric nanoparticles, preferably nanocapsules of finasteride and minoxidil, a composition suitable for topical application for the treatment of alopecia, as well as the use of said nanocapsules for the preparation of a pharmaceutical composition.

Abstract: The present invention relates to a drug delivery composition comprising proteins and biodegradable polymers. The present invention further relates to a drug delivery system for controlled and long term release of proteins into a biological environment. The drug delivery composition comprises at least a protein and a biodegradable polymer possessing at least two different functional groups selected from the group of chosen among carboxyl-, ester-, amine-, amide-, thiol-, thioester- or hydroxyl groups pendant to the main polymer chain whereby the composition absorbs between 5-10% w/w water when exposed to physiological conditions for at least 20 days. The present invention further relates to a drug delivery system for controlled protein release comprising the composition. The drug delivery system may be chosen from microparticles, films, coatings, fibers, pellets, cylinders, discs, implants, microcapsules, microspheres, nanospheres, wafers, micelles, liposomes or woven or non-woven fabrics.

Abstract: The present invention is directed to a buprenorphine sustained release delivery system capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 14 days to about 3 months. The buprenorphine sustained release delivery system includes a flowable composition and a solid implant for the sustained release of buprenorphine, a metabolite, or a prodrug thereof. The implant is produced from the flowable composition. The buprenorphine sustained release delivery system provides in situ 1-month and 3-month release profiles characterized by an exceptionally high bioavailability and minimal risk of permanent tissue damage and typically no risk of muscle necrosis.

Abstract: Compositions and methods for modifying biologically active substances to achieve multi-day delivery of such substances, particularly through oral or parenteral administration, are disclosed. The compositions include the biologically active substance conjugated to a carrier having a suitably long half life, typically more than one day, wherein the conjugate optionally contains a spacer linking the carrier to the biologically active substance. Pharmaceutical formulations of the conjugates are also disclosed, as are methods of extending delivery of a single dose of a biologically active substance for more than one day.

Abstract: In certain embodiments, this disclosure relates to pharmaceutical formulations for polypeptide and lipophilic moiety conjugates suitable for injection into humans and other animals and methods of preparation. In certain embodiments, the disclosure relates to a method of preparing the formulation comprising lyophilizing, solubilizing in ammonium acetate, filtering to create mono-disperse particles, re-lyophilizing, and solubilizing the micelles in a dextrose solution for injection.

Abstract: Provided is a co-polymer of formula A-L-D, or a pharmaceutically acceptable salt thereof, wherein A is a linear, branched or dendritic polyamine; D is a lipid; and L is a linker comprising a water soluble polymer; wherein L is connected to A at a first end through a first covalent bond and connected to D at a second end through a second covalent bond.

Abstract: The present invention relates to extended release compositions of an amino-C2-C6-alkyl nitrate and of pharmaceutically acceptable salt thereof, in particular 2-aminoethyl nitrate, and to fixed dose combinations with further pharmaceutically active drug substances. 2-Aminoethyl nitrate does not provoke nitrate tolerance, but has a very short half life in physiological systems.

Abstract: The present invention relates to novel therapeutic dendrimer conjugates configured for the treatment and/or prevention of organophosphate poisoning. In particular, the present invention is directed to dendrimers complexed with organophosphate poisoning antidotes (e.g., pralidoxime (2-PAM) (4-PAM), obidoxime, trimedoxime, asoxime (HI-6), hydroxamate, and related analogs, salts and derivatives thereof), compositions comprising such dendrimer conjugates, related methods of synthesizing such dendrimer conjugates, as well as systems and methods utilizing such dendrimer conjugates (e.g., in diagnostic and/or therapeutic settings (e.g., for the delivery of therapeutics, imaging, and/or targeting agents (e.g., in the treatment and/or prevention of organophosphate poisoning)).

Abstract: Novel compounds of the general formula: in which X represents a polymer, Q represents a linking group; W represents an electron-withdrawing moiety or a moiety preparable by reduction of an electron-withdrawing moiety; each of R1 and R2 independently represents a hydrogen atom or a C1-4alkyl group; and either Z1 represents a protein or a peptide linked to CR2 via a nucleophilic moiety, and Z2 represents a molecule linked to CR2 via a nucleophilic moiety, or Z1 and Z2 together represent a single group derived from a protein or peptide linked to CR2 via two nucleophilic moieties.

Abstract: The invention is directed to a single-step method for rapidly and efficiently preparing protein-polymer conjugates, including an insulin-polymer conjugate. According to the method of the present invention, a protein and hydrophilic polymer are contacted in the presence of at least one organic solvent and at least one metal chelator, under conditions that promote the formation of a conjugate of the protein and polymer. Thus, the invention is directed to the site-specific modification of selected proteins, such as insulin, with poly(ethylene glycol) at residue PheB1. The invention also provides a pharmaceutical formulation for encapsulating the conjugate in a biodegradable polymer.

Abstract: The invention provides eTEC linked glycoconjugates comprising a saccharide covalently conjugated to a carrier protein through a (2-((2-oxoethyl)thio)ethyl)carbamate (eTEC) spacer, immunogenic compositions comprising such glycoconjugates, and methods for the preparation and use of such glycoconjugates and immunogenic compositions.

Abstract: The present invention relates to therapeutic immunoconjugates comprising SN-38 attached to an antibody or antigen-binding antibody fragment. The antibody may bind to EGP-1 (TROP-2), CEACAM5, CEACAM6, CD74, CD19, CD20, CD22, CSAp, HLA-DR, AFP or MUC5ac and the immunoconjugate may be administered at a dosage of between 4 mg/kg and 24 mg/kg, preferably 4, 6, 8, 9, 10, 12, 16 or 18 mg/kg. When administered at specified dosages and schedules, the immunoconjugate can reduce solid tumors in size, reduce or eliminate metastases and is effective to treat cancers resistant to standard therapies, such as radiation therapy, chemotherapy or immunotherapy.

Abstract: Disclosed herein are compositions comprising lipid based particles and anti-ENDO180 antibodies and to methods of using the same for targeted delivery of therapeutic agents to cancer and fibrotic cells useful for treating cell proliferative diseases or disorders including fibrosis, cancer and to attenuate tumor progression.