Abstract: The invention relates to a composition and a method for manufacturing semi-dry or dry particles containing a mucoadhesive polymer and a bioactive agent such as, but not limited to, an Immunogenic Substance (e.g., a vaccine), that allows the oral or nasal administration and delivery of the bioactive agent essentially unaltered to mucosal surfaces in the animal, including an aquatic animal.

Abstract: The invention relates to compositions including a substance useful as an adjuvant for potentiating an immune response, and methods of using the composition in individuals with infections of tissue within or adjacent to a transformation zone, such as the transformation zone of the cervix or anal canal.

Abstract: This disclosure provides IL-21 binding molecules, e.g., anti-IL-21 antibodies and antigen-binding fragments thereof. In certain aspects the anti-IL-21 antibodies and fragments thereof can be hybridoma-derived murine monoclonal antibodies, and humanized versions thereof. In certain aspects the binding molecules, e.g., anti-IL-21 antibodies and antigen-binding fragments thereof provided herein inhibit, suppress, or antagonize IL-21 activity. In addition, this disclosure provides compositions and methods for diagnosing and treating diseases or disorders, e.g., inflammatory, immune-mediated, or autoimmune diseases or disorders associated with IL-21-mediated signal transduction. In a particular embodiment, the disclosure provides methods for treating or preventing Graft-versus-host disease (GVHD) using IL-21 binding molecules, e.g., anti-IL-21 antibodies and antigen-binding fragments thereof.

Abstract: The inventors have discovered that both soluble erythropoietin-binding protein and antibodies against the erythropoietin-binding protein, when they are administered to a mammal along with erythropoietin (Epo), prevent or reduce the blood pressure increase normally caused by erythropoietin, while not affecting the hematocrit increase that is the purpose of Epo treatment. The invention provides a method of treating anemia in a mammal involving: administering erythropoietin (Epo) to the mammal; and administering to the mammal an agent selected from a soluble Epo-binding protein (Epo-bp), a recognition protein that binds Epo receptor on an extracellular soluble portion of the Epo receptor, and a combination thereof. The invention also provides a method of reducing hypertension in a mammal receiving Epo, and pharmaceutical compositions containing a soluble Epo-bp and/or a recognition protein that binds Epo receptor on an extracellular soluble portion of the Epo receptor.

Abstract: Isolated human monoclonal antibodies which bind to human CD74 and related antibody-drug conjugates are disclosed. Pharmaceutical compositions comprising the antibodies or antibody-drug conjugates, and therapeutic and diagnostic methods for using the antibodies and/or antibody-drug conjugates, are also disclosed.

Abstract: The present invention provides: an antibody that has specificity for MUC 4 having a sugar chain structure that is expressed at a high level in cancer cells; a glycopeptide that constitutes an antigen that is suitable for producing this antibody; and a new means and method for the diagnosis, prevention, and/or treatment of cancer by means of the aforementioned antibody. The present invention relates to a monoclonal antibody against a glycopeptide. The glycopeptide comprises a human MUC 4 tandem unit peptide having an amino acid sequence represented by SEQ ID NO: 1, and an O-linked sugar chain. The O-linked sugar chain is N-acetylgalactosamine (GalNAc) and binds to threonine, which is the 8th amino acid of the tandem unit peptide.

Abstract: A Candida albicans bloodstream infections cause significant morbidity and mortality in hospitalized patients. Filament formation and adherence to host cells are critical virulence factors of C. albicans. Multiple filamentation regulatory pathways have been discovered, however the downstream effectors of these regulatory pathways remain unknown. The cell surface proteins in the ALS group are downstream effectors of the filamentation regulatory pathway. Particularly, Als1p mediates adherence to endothelial cells in vitro and is required for virulence. The blocking of adherence by the organism is described resulting from the use of a composition and method disclosed herein. Specifically, a pharmaceutical composition comprised of a gene, gene product, or specific antibody to the ALS gene family is administered as a vaccine to generate an immune response capable of blocking adherence of the organism.

Abstract: Disclosed herein is a multiple drugs delivery system and its uses in treating diseases. The multiple drugs delivery system includes, an anti-PEG antibody for directing the PEGylated therapeutic to the treatment site; and a hydrogel for retaining the anti-PEG antibody and/or the PEGylated therapeutic at the treatment site for at least 3 days. The hydrogel is selected from the group consisting of hyaluronan (HA) or a derivative of HA, collagen, gelatin, fibronectin, fibrinogen, alginate, chitosan, and a synthetic biocompatible polymer. The anti-PEG antibody and the hydrogel are present in the mixture in a ratio from about 1:1 (v/v) to 1:100 (v/v). At least two dosages of the PEGylated therapeutic, which may be the same or different, are administered to the subject, with each dosage being given at about 1 hour to about 1 week apart. Accordingly, a novel method of treating a subject having cancer or ischemic disease is also provided.

Abstract: The present invention is a glutamine compound having a non-radioisotope high Z element attached via a linker, which enters the mitochondrion and is subsequently exposed to ionizing radiation. When exposed to ionizing radiation, the present invention damages mitochondrial (as well as other) substructures such as mtDNA, the outer membrane, the inner membrane, cristae, ribosomes, etc., and causes the effective destruction of such mitochondrion. Tumorigenic cells without mitochondria cannot produce the energy they need to subsist and replicate, effectively starving them of energy and causing their destruction.

Abstract: The invention provides a colon cleansing solution comprising: a) 300 to 800 mmol per litre ascorbate anion provided by a mixture of: (i) ascorbic acid and (ii) one or more salts of ascorbic acid the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and b) 10 to 200 g per litre polyethylene glycol. The invention also provides methods and kits associated with, or making use of the solutions, and compositions for the preparation of the solutions.

Abstract: Disclosed are methods of making oral pharmaceutical compositions that contain substantially crush resistant drug containing microparticles. The microparticles may contain an active pharmaceutical agent, a polymer and a plasticizer. The microparticles may be un-coated (so as to impart an immediate release profile) or coated so as to impart an extended release (ER), delayed release (DR) or delayed extended release (DER) profile. One or more of the populations of microparticles may be coated with a taste masking composition. The methods may produce oral compositions such as orally disintegrating tablets that contain one or more these types of microparticles in order to further customize the release profile. Also disclosed are the oral compositions, per se, and methods of using same for their intended purposes.

Abstract: Disclosed herein is a use of a composition, comprising a non-toxic polyanionic material or a salt thereof to dissociate a polymeric membrane. In addition, a method of dissociating a polymeric membrane is also presented, the method comprising the steps of providing a polymeric membrane; and dissociating the polymeric membrane by adding a composition comprising a non-toxic polyanionic material to the polymeric membrane.

Abstract: An aqueous composition useful for producing capsules shells comprises a) at least one dispersed esterified cellulose ether comprising (i) groups of the formula —C(O)—R—COOA or (ii) a combination of aliphatic monovalent acyl groups and groups of the formula —C(O)—R—COOA, wherein R is a divalent aliphatic or aromatic hydrocarbon group and A is hydrogen or a cation, and b) from 0.05 to 20 percent of at least one salt of a fatty acid, based on the weight of the dispersed esterified cellulose ether, wherein the median particle size, d50, of the dispersed esterified cellulose ether particles is up to 7 micrometers, such median particle size (d50) being the size at which 50 mass percent of the particles have a smaller equivalent diameter and 50 mass percent have a larger equivalent diameter.

Abstract: Provided is a composition for forming a film, the composition not having completely dissolved hydroxypropyl methyl cellulose (HPMC), and enabling formation of the film having a uniform thickness by suppressing the viscosity increase of the composition around an immersion temperature of 50° C. More specifically provided is a composition for forming a film, the composition comprising hypromellose having methoxy group content of 28.0 to 30.0% by weight and hydroxypropoxy group content of 7.6 to 8.5% by weight, wherein a 2% by weight aqueous solution of the hypromellose provides a viscosity at 20° C. of 4.0 to 6.5 mPa·s, a 20% by weight dispersion of the hypromellose provides a viscosity at 50° C. of 2,000 to 11,000 mPa·s, and a 20% by weight aqueous solution of the hypromellose provides a gelation temperature of 54 to 57° C.; and a solvent.

Abstract: Embodiments of various aspects described herein are directed to silk-based compositions for ocular delivery of at least one active agent, e.g., at least one therapeutic agent and methods of using the same. In some embodiments, the silk-based compositions can provide sustained release of at least one therapeutic agent to at least a portion of an eye. Thus, some embodiments of the silk-based compositions can be used for treatment of an ocular condition, e.g., age-related macular degeneration.

Abstract: Compositions are disclosed herein that comprise a mixture of at least one Albizia extract and a Magnolia extract. In some embodiments, the composition comprises a mixture of at least one Albizia extract enriched for one or more macrocyclic alkaloids and at least one Magnolia extract enrich for one or more lignans.

Abstract: The present invention relates in one aspect to a conjugate of a mucopolysaccharide or mucopolysaccharidic fraction and a cellular wall fragment of a bacterium belonging to the Corynebacterium genus, and in particular to the Corynebacterium granulosum species, also named P40. The conjugate of the invention is applied to medicine, in particular for topical treatment of infections, dermatological affections, such as psoriasis, acne, allergic reactions, such as rashes and eczema, and in vaginal mucosae affections.

Abstract: 1H-Imidazo[4,5-c]quinolin-4-amines substituted at the 1-position with a substituent bearing a hydrazinobenzamide or hydrazinonicotinamide, a salt thereof, or a protected hydrazinobenzamide or hydrazinonicotinamide and conjugates made from such compounds are disclosed. Pharmaceutical compositions containing the compound or the conjugate, methods of making a conjugate, and methods of use of the compounds or conjugates as immunomodulators for inducing cytokine biosynthesis in an animal and for vaccinating an animal are also disclosed.

Abstract: The present invention relates to the field of gastroenterology and, more particular, to the field of intestinal diseases. More specifically, it concerns uses and methods for the treatment of inflammatory bacterial diseases of the intestine. In particular, it relates to diseases that are associated with bacterial invasion of the intestinal mucus, including, inflammatory bowel diseases, and infectious bacterial diseases. Therefore, the present invention provides agents, a pharmaceutical composition and a kit for treating said diseases. It further relates to a use and a method for treating invasive bacterial diseases of the large intestine.

Abstract: The invention described herein provides a preparation comprising a non-mammalian derived mixture of serine glycerophospholipid conjugates with a specific content and specific conjugation patterns of LA, linolenic acid (alpha-linolenic acid, gamma-linolenic acid) DHA and EPA which depend on utilizing different sources of lipids, and uses of such preparations.

Abstract: The present invention concerns methods and compositions for treatment of HIV infection in a subject. The compositions may comprise a targeting molecule against an HIV antigen, such as an anti-HIV antibody or antibody fragment. The anti-HIV antibody or fragment may be conjugated to a variety of cytotoxic agents, such as doxorubicin. In a preferred embodiment, the antibody or fragment is P4/D10. Other embodiments may concern methods of imaging, detection or diagnosis of HIV infection in a subject using an anti-HIV antibody or fragment conjugated to a diagnostic agent. In alternative embodiments, a bispecific antibody with at least one binding site for an HIV antigen and at least one binding site for a carrier molecule may be administered, optionally followed by a clearing agent, followed by administration of a carrier molecule conjugated to a therapeutic agent.

Abstract: Cell binding agent-drug conjugates comprising bridge linkers, and methods of using such linkers and conjugates are provided.

Abstract: Disclosed herein are nanoconstructs comprising a nanoparticle, coated with additional agents such as cationic polymers, stabilizers, targeting molecules, labels, oligonucleotides and small molecules. These constructs may be used to deliver compounds to treat solid tumors and to diagnose cancer and other diseases. Further disclosed are methods of making such compounds and use of such compounds to treat or diagnose human disease.

Abstract: Method for preparing a supramolecular therapeutic agent delivery assembly are provided. A carbonate-containing precursor, a functionalized aliphatic precursor, and an aromatic diamine precursor may be combined to form an amphiphilic block co-polymer. The block co-polymer undergo a cross-linking polymerization process and a therapeutic agent may be incorporated into the resulting supramolecular assembly. The supramolecular assembly may comprise HT, PHT, HA, and/or PHA materials.

Abstract: The present disclosure provides POZ derivatives having a range of active functional groups allowing conjugation of POZ derivatives to a variety of target molecules under a wide range of reaction conditions to produce a hydrolytically stable target molecule-POZ conjugate. Furthermore, the present disclosure provides novel methods of synthesis for the disclosed POZ derivatives and hydrolytically stable target molecule-POZ conjugates created using the disclosed terminally activated monofunctional POZ derivatives. In one embodiment, the POZ derivative is a terminally activated monofunctional POZ derivative.

Abstract: A composition comprising poly(amidoamine) (PAMAM) hydroxyl-terminated dendrimers covalently linked to at least one therapeutic, prophylactic or diagnostic agent for the treatment or alleviation of one or more symptoms of a brain tumor have been developed. The dendrimers comprise one or more ethylene diamine-core poly(amidoamine) (PAMAM) hydroxyl-terminated generation-4, 5, 6, 7, 8, 9, or 10, most preferably generation 6 (G4-10-OH) dendrimers. The G6 dendrimers have demonstrated unexpectedly high uptake into the brain. The dendrimers provide a means for selective delivery through the blood brain barrier (“BBB”) of chemotherapeutic, immunotherapeutic and palliative agents. The dendrimers also have the advantage that two different classes of compounds, having one or more mechanisms of action can be bound to the dendrimers, providing simultaneous delivery. The dendrimers may be administered alone by intravenous injection, or as part of a multi-prong therapy with radiation.

Abstract: The present disclosure provides peptides and peptide compositions, which facilitate the delivery of an active agent or an active agent carrier wherein the compositions are capable of penetrating the stratum corneum (SC) and/or the cellular membranes of viable cells.

Abstract: The present invention is directed to bladder cancer specific ligand peptides, comprising the amino acid sequence X1DGRX5GF (SEQ ID NO: 1), and methods of their use, e.g., for imaging detection for diagnosis of bladder, tumor localization to guide transurethral resection of bladder cancer, imaging detection of bladder cancer for follow-up after the initial treatment that can replace or complement costly cystoscopy, imaging detection of metastatic bladder cancer, and targeted therapy for superficial and metastatic bladder cancer.

Abstract: Compounds, compositions, and methods are provided for covalently linking an antibody or an antibody fragment to a cargo molecule, such as a therapeutic or a diagnostic agent, using a combination of enzymatic glycan remodeling and click chemistry. The method allows a cargo molecule to be selectively and efficiently attached post-translationally to an antibody or an antibody fragment. Also provided are antibody drug conjugates, methods of making, and uses thereof.

Abstract: Cell binding agent-drug conjugates comprising bridge linkers, and methods of using such linkers and conjugates are provided.

Abstract: Devices, compositions, and methods are described which provide a tubular nanostructure or a composite tubular nanostructure targeted to a lipid bilayer membrane. The tubular nanostructure includes a hydrophobic surface region flanked by two hydrophilic surface regions. The tubular nanostructure is configured to interact with a lipid bilayer membrane and form a pore in the lipid bilayer membrane. The tubular nanostructure may be targeted by including at least one ligand configured to bind to one or more cognates on the lipid bilayer membrane of a target cell.

Abstract: The present invention provides compositions containing clopidogrel, present as a free base or a pharmaceutically acceptable salt thereof, and sulfoalkyl ether cyclodextrin (SAE-CD). The compositions can be liquid, suspension or solid compositions. They can be adapted for oral, peroral or parenteral administration. The SAE-CD serves to aid in dissolution and stabilization of the clopidogrel in aqueous media. The stability of clopidogrel against hydrolytic degradation, thermal degradation, and photolytic degradation are improved. SAE-CD provides improved results over other cyclodextrin derivatives. The SAE-CD-containing composition of clopidogrel can be provided in liquid form, solid form or as a reconstitutable powder. Both ready-to-use and concentrated liquid compositions can be prepared. The liquid composition is optionally available as a clear solution.

Abstract: The present invention provides an agent for controlling Escherichia coli diarrhea comprising a Shiga toxin as an active ingredient.

Abstract: The present invention relates to compositions and methods for cancer immunotherapy. In particular, the present invention relates to engineered effector B cells and their use in cancer immunotherapy.

Abstract: The present disclosure is directed to adeno-associated viral vector monoclonal antibody constructs and compositions thereof, methods of improving locomotor function after spinal cord injury, methods of treating neurodegenerative diseases.

Abstract: A polyion complex of mRNA and a polycationic polymer, and a composition and a pharmaceutical composition for mRNA delivery are provided. The polyion complex of mRNA and the polycationic polymer can deliver mRNA into cells in the body of a subject almost without inducing inflammation. The polyion complex can then cause mRNA to be uniformly expressed in cells in the body of the subject. The pharmaceutical composition containing the polyion complex is suitable for use in treating a disease whose condition rapidly progresses or an acute disease.

Abstract: Provided herein are methods for treating retinitis pigmentosa using an AAV particles encoding miR-708. In one aspect, viral particles are administered to the eye of a human subject; for example, by subretinal injection. Viral particles comprising AAV5 capsids or mutants thereof are contemplated.

Abstract: The present invention relates to the prevention and/or treatment of lysosomal storage diseases in a patient.

Abstract: The presently disclosed subject matter provides for expression cassettes that allow for expression of a globin gene or a functional portion thereof, vectors comprising thereof, and cells transduced with such expression cassettes and vectors. The presently disclosed subject matter further provides methods for treating a hemoglobinopathy in a subject comprising administering an effective amount of such transduced cells to the subject.

Abstract: The invention provides a murine model of wound infection and biofilm formation and methods for producing such model. The inventive murine model of wound infection may be used to evaluate pathogen virulence and test efficacy of a pharmaceutical composition and/or a treatment procedures in preventing or treating wound infection, reducing biofilm formation, or reducing symptoms in a subject.

Abstract: The invention describes a coordination polymer construct for multimodal imaging and therapy. The construct consists of a core particle made of a novel coordination polymer. The core is coated with a biocompatible coating that stabilizes the particles in a physiological environment. The biocompatible coating can contain attached targeting agents, imaging agents and therapeutic agents or combinations one or more of the targeting, imaging and therapeutic agents. When administered to a subject or a subject-derived specimen, the resulting coordination polymer core-shell construct enables multimodal imaging and therapy, which improves the diagnostic and treatment outcomes of the conditions or diseases where it is administered. The invention describes the novel material, base for the construct, methods for the preparation of the said construct and its use as a multimodal imaging and therapy agent.

Abstract: The present invention is related generally to measurement of body fluid volumes in an animal subject. The body fluid volumes of interest include extracellular fluid volume (ECFV), total vascular plasma volume (TVPV) and interstitial fluid volume (IFV). The methods are especially beneficial for subjects suffering from renal failure and particularly those undergoing renal dialysis. ECFV can be measured by administering a first molecule which is non-metabolized and permeable to vessel walls of the vascular system wherein the first molecule is distributed within the total vascular space as well as the interstitial space. TVPV can be measured by administering a second molecule which is non-metabolized and impermeable to vessel walls of the vascular system wherein the second molecule is distributed within only the vascular space. IFV can then be calculated using the equation IFV=ECFV?TVPV.

Abstract: The invention relates to liquid vehicles that can be used to create dilute solutions of water-soluble pharmaceutical or non-pharmaceutical oral contrast agents. The liquid vehicles are formulated to provide desired osmolalities, viscosities, pH, and taste masking capabilities to match the particular intentions of the user and to complement the inherent differences in the various oral contrast agents. The liquid vehicles comprise an aqueous medium, an osmotic agent to adjust osmolality, a buffering agent, a viscosity agent, and sweeteners and flavoring agents to improve palatability.

Abstract: Lipid nanoparticles expressing metal ions and methods for using the compositions for magnetic resonance imaging.

Abstract: A method for evaluating treatment outcome in a patient having a genetic predisposition for a malignant neoplasm before clinical manifestation of the neoplasm can be seen radiographically. The method permits visualization of any tumor, whether located externally on a patient's body or located internally in the body, and as small as 2 mm in diameter, using a biomarker. The method uses biomarkers conjugated with nanoparticles which include but are not limited to quantum dots, with the conjugated form collectively termed functionalized nanoparticles, that are heated under specified conditions to produce a photoacoustic signal that is then visualized to locate and/or treat the tumor.

Abstract: Sterilization method according to which an aqueous polysaccharide solution is stored in the presence of a lactone and a buffer system for a period of at least 24 hours, and a sterile polysaccharide solution produced in this way.

Abstract: Methods of sterilizing medical devices, including implantable medical devices like stents, chemically and with radiation are disclosed. Methods of preparing a sterile, packaged medical device, including a sterile, packaged implantable medical device or stent are disclosed.

Abstract: A metal mesh has a plurality of through-holes. A photosensitive organic material is attached to at least part of the metal mesh. The metal mesh is sterilized and/or cleaned. A determination of whether or not the sterilization and/or cleaning has been successful is made by analyzing the photosensitive organic material attached to the metal mesh.

Abstract: Disinfection methods and apparatuses are provided which generate pulses of germicidal light at a frequency greater than 20 Hz and project the pulses of light to surfaces at least 1.0 meter from the disinfection apparatus. The pulses of light comprise a pulse duration and an energy flux sufficient to generate a power flux between approximately 200 W/m2 and approximately 5000 W/m2 of ultraviolet light in the wavelength range between 200 nm and 320 nm at the surfaces. Other disinfection methods and apparatuses are provided which generate pulses of light comprising germicidal light and visible light from a germicidal light source and generate pulses of light from a visible light source that is distinct from the germicidal light source. The projections of visible light from the light sources produce a continuous stream of visible light or a collective stream of visible light pulsed at a frequency greater than 60 Hz.

Abstract: The present disclosure relates to compositions comprising hydrogen peroxide in combination with C6-10 fatty acid, C6-10 fatty acid ester derivatives, or mixtures thereof, as well as products incorporating the compositions, and methods of using the compositions and products.