Abstract: The present invention provides, among other things, compositions and methods for CNS delivery of lysosomal enzymes for effective treatment of lysosomal storage diseases. In some embodiments, the present invention includes a stable formulation for direct CNS intrathecal administration comprising an iduronate-2-sulfatase (I2S) protein, salt, and a polysorbate surfactant for the treatment of Hunters Syndrome.

Abstract: To provide a method for evaluating or selecting an agent for reducing sensory irritation, which reduces sensory irritation caused by parabens, and an agent for reducing sensory irritation, which reduces sensory irritation caused by parabens. A method for evaluating or selecting an agent for reducing sensory irritation caused by parabens, comprising the following steps (1) to (3): (1) a step of contacting cells capable of expressing CES1 with a test substance; (2) a step of measuring expression of CES1 in the cells; (3) a step of evaluating a test substance which promotes expression of CES1 as an agent for reducing sensory irritation caused by parabens based on the results measured in (2).

Abstract: Disclosed are methods for ameliorating glycocalyx damage by administering a neuraminidase inhibitor. Also disclosed are methods for treating endothelial dysfunction and for improving flow mediated dilation.

Abstract: Provided herein are in vivo gelling ophthalmic pre-formulations forming a biocompatible retinal patch comprising at least one nucleophilic compound or monomer unit, at least one electrophilic compound or monomer unit, and optionally a therapeutic agent and/or viscosity enhancer. In some embodiments, the retinal patch at least partially adheres to the site of a retinal tear. Also provided herein are methods of treating retinal detachment by delivering an in vivo gelling ophthalmic pre-formulation to the site of a retinal tear in human eye, wherein the in vivo gelling ophthalmic pre-formulation forms a retinal patch.

Abstract: Provided herein is a stabilized DNase I polypeptide containing a non-standard amino acid that maintains enzymatic activity even under harsh conditions, such as reducing environments. The stabilized DNase I polypeptide has enzymatic activity in reducing environments that is higher than a corresponding DNase I polypeptide without the non-standard amino acids under the same conditions. Also provided herein are polynucleotides encoding the stabilized DNase I polypeptide, cells for expressing and/or producing the stabilized DNase I polypeptide, and methods of use of the stabilized DNase I polypeptide.

Abstract: The invention provides a method for the treatment or prevention of microbial overgrowth in at least part of the intestinal tract of a subject, said method comprising administering an effective amount of an alginate oligomer to a subject in need thereof. Also provided is an alginate oligomer for use in the treatment or prevention of microbial overgrowth in at least part of the intestinal tract of a subject and a product containing an alginate oligomer and further pharmaceutical for the treatment of intestinal microbial overgrowth and/or a CFTR modulator as a combined preparation for separate, simultaneous or sequential use in the treatment or prevention of microbial overgrowth in at least part of the intestinal tract of a subject.

Abstract: The present disclosure relates in general to therapeutic lysosomal enzyme fusion proteins useful for treating lysosomal storage diseases, liquid formulations comprising such fusion proteins and associated methods useful for treating lysosomal storage diseases in mammals.

Abstract: The invention provides compositions and methods for utilizing oligosaccharides, such as isolated human milk oligosaccharides, to attenuate a respiratory pathogen infection-induced host inflammation and/or to promote recovery from a respiratory pathogen infection-induced host inflammation in a subject.

Abstract: A composition comprising branched fructan molecules derived from a fructan extract of perennial high sugar grass (HSG) selected from the group consisting of AberMagic cultivar, AberDart cultivar, and S48 (Lolium spp), and obtained by enzymic endo-hydrolase hydrolysis, wherein said branched fructan molecules have a molecular weight of between 0.3 to 3 kDa, and wherein at least 50% of the branched fructan molecules present in the composition have a molecular weight of between 0.48 and 1.9 kDa is provided. Also provided are feed or food supplement comprising such a composition, a method of producing a composition comprising branched fructan molecules, and a method of making a feed or foodstuff.

Abstract: Compositions and uses involving L. monocytogenes PssZ, as well as homologs, variants, and fragments thereof, are described.

Abstract: Exemplary embodiments of the disclosure may be drawn to a device having an inlet and a chamber. Immobilized lipase, immobilized protease, and immobilized amylase may be contained within the chamber. The device may also include an outlet, wherein a flow path extends from the inlet, through the chamber, and to the outlet.

Abstract: The present invention provides, among other things, compositions and methods for CNS delivery of lysosomal enzymes for effective treatment of lysosomal storage diseases. In some embodiments, the present invention includes a stable formulation for direct CNS intrathecal administration comprising an iduronate-2-sulfatase (I2S) protein, salt, and a polysorbate surfactant for the treatment of Hunters Syndrome.

Abstract: A method for ex vivo treating blood or plasma is provided. The method includes (a) ex vivo contacting a blood or plasma with an enzyme composition to react the enzyme composition with the blood or plasma, wherein the enzyme composition is capable of eliminating electronegative low-density lipoprotein from the blood or plasma by the activity of the enzyme composition, and the enzyme composition is selected from a group consisting of: a first enzyme for eliminating a glycan residue of an electronegative low-density lipoprotein (LDL); a second enzyme for eliminating ceramide carried by a electronegative low-density lipoprotein (LDL); and a combination thereof; and (b) terminating contact between the blood or plasma and the enzyme composition to terminate the reaction of the enzyme composition with the blood or plasma.

Abstract: Methods and compositions for treating Middle East respiratory syndrome coronavirus (MERS-CoV) infection using polypeptides having sialidase activity are provided herein.

Abstract: Modified DNase I protein in which one or more amino acids of a DNase I protein are modified non-cellularly, are provided. The modified DNase I protein exhibits a DNA hydrolytic activity in the presence of actin and an improved DNA hydrolytic activity compared to a homologous non-modified DNase I protein. Processes of preparing the modified DNase I protein and uses thereof in, for example, reducing a DNA content in sputum and/or in treating a disease or condition associated with excess extracellular DNA in a fluid, secretion or tissue of a subject, are also provided.

Abstract: Compositions and methods for controlling pests are provided. The methods involve transforming organisms with a nucleic acid sequence encoding an insecticidal protein. In particular, the nucleic acid sequences are useful for preparing plants and microorganisms that possess insecticidal activity. Thus, transformed bacteria, plants, plant cells, plant tissues and seeds are provided. Compositions are insecticidal nucleic acids and proteins of bacterial species. The sequences find use in the construction of expression vectors for subsequent transformation into organisms of interest including plants, as probes for the isolation of other homologous (or partially homologous) genes. The pesticidal proteins find use in controlling, inhibiting growth or killing Lepidopteran, Coleopteran, Dipteran, fungal, Hemipteran and nematode pest populations and for producing compositions with insecticidal activity.

Abstract: A system and methods for the delivery of oxygen through a body cavity of a subject using oxygen microbubbles. Through circulation of oxygen microbubbles through the body cavity, oxygen and carbon dioxide exchange may occur. Overall improvement in extending survival rate time during emergency situations caused by pulmonary or similar oxygen-intake restricting injury and/or failure may be achieved through use of the invented system and methods.

Abstract: Methods for stimulating plant growth and/or promoting plant health using free enzymes or recombinant microorganisms that overexpress enzymes are provided. Plant seeds coated with free enzymes or recombinant microorganisms that overexpress enzymes are also provided. Compositions comprising a fertilizer and an enzyme or a recombinant microorganism that overexpresses an enzyme are provided. Modified enzymes having ACC deaminase activity, recombinant microorganisms expressing the modified enzymes, plant seeds treated with the modified enzymes or recombinant microorganisms, and methods for stimulating plant growth and/or promoting plant health using the modified enzymes or recombinant microorganisms are also provided.

Abstract: This invention relates to viral vectors for delivery of alpha-L-iduronidase to the cornea of a subject and methods of using the same for treatment and prevention of corneal clouding and blindness in a subject due to mucopolysaccharidosis I.

Abstract: Provided herein are small molecule-inhibitors of site-specific O-glycosylation and the identification of such using cell-based fluorescent biosensors. Also provided herein are methods of treating kidney disease and cancer, such as breast cancer.

Abstract: Provided are substantially dephosphorylated forms of lysosomal storage disease (LSD) proteins, including dephosphorylated forms of iduronate-2-sulfatase (IDS, or I2D) and iduronidase (IDU), having increased ability to traverse or penetrate the blood brain barrier (BBB) relative to phosphorylated forms of the protein, and p97 conjugates thereof. Also provided are compositions comprising such dephosphorylated LSD proteins and p97 conjugates, and methods of use thereof, for instance, to treat any one or more lysosomal storage diseases, such as Hunter Syndrome (or MPS Type II).

Abstract: The invention relates to therapeutic compositions, solid oral dosage forms, and methods for treating, preventing, or alleviating lower urinary tract symptoms (LUTS), benign prostatic hyperplasia (BPH), erectile dysfunction (ED), urinary incontinence, bladder obstruction, overactive bladder (OAB), underactive bladder, interstitial cystitis, prostatitis, bladder and prostate inflammation, prostate fibrosis or pelvic pain. The therapeutic compositions can comprise cranberry powder enriched in cranberry seeds or cranberry seed meal.

Abstract: A wet wiper for cleaning an oral cavity or an oral appliance. The wet wiper comprises a water insoluble substrate and a physiologically acceptable cleansing composition. Methods for cleansing oral cavities and oral appliances are also provided, such methods comprising the step of contacting the surface of an oral cavity or an oral appliance with a wet wiper of the present invention for a sufficient time to permit cleaning.

Abstract: A wet wiper for cleaning accumulated oral debris from removable dental appliances. The wet wiper comprises (a) a water insoluble substrate; and (b) a physiologically acceptable cleansing composition, said cleansing composition comprising: a solution of water and a flavorant, wherein said water is up to about 97% by weight of said cleansing composition; and said flavorant is about 0.001% to about 5% by weight of said cleansing composition. Methods for cleaning removable dental appliances are also provided, such methods comprising the step of contacting, for a time sufficient to reduce oral debris, the removable dental appliances, with a wet wiper of the present invention.

Abstract: The present invention provides compositions and methods for prevention, amelioration and treatment of gram positive bacteria, particularly Staphylococcal bacteria, with combinations of lysin, particularly Streptococcal lysin, particularly the lysin PlySs2, and one or more antibiotic, including daptomycin, vancomycin, oxacillin, linezolid, or related antibiotic(s).

Abstract: A vector have an expression cassette containing have a hIDUA gene has a sequence of SEQ ID NO: 1 (FIG. 1) or a sequence at least about 95% identical thereto which encodes a functional human alpha-L-iduronidase is provided. The vector may be a production vector or a rAAV8. Also provided are compositions containing these vectors and methods of treating MPSI and the symptoms associated with Hurler, Hurler-Scheie and Scheie syndromes.

Abstract: A method is for the treatment of a condition in a subject, which arises from or is associated with CFTR dysfunction. The method includes administering to the subject an effective amount of a CFTR modulator together with an effective amount of an alginate oligomer. The condition can be cystic fibrosis (CF), non-compound CFTR gene mutation heterozygosity, abnormal mucus clearance in the respiratory tract and/or breathing difficulties resulting from chronic particulate inhalation, COPD, chronic bronchitis, emphysema, bronchiectasis, asthma or chronic sinusitis, or a complication of any of these.

Abstract: In various aspects, the invention relates to immune tolerant glycosidase therapy. The invention provides methods for treating or preventing infectious disease, including chronic viral infections, and highly contagious infectious agents that present an ongoing challenge for the immune system. The compositions and treatment regimens find use with other antiviral or antimicrobial therapies, as well as in conjunction with vaccination to boost effectiveness and/or extend the duration of protective effect. In certain embodiments, the regimen described herein reduces or eliminates the need for administration of other traditional antiviral or antimicrobial therapies. In various embodiments, the invention finds use in immunocompromised patients to boost immune function.

Abstract: Trp-containing peptides, preferably from hen's egg hydrolysate can increase the Cys levels in blood serum. This results in increased keratin production, and enhances growth, appearance, and/or volume in keratin-containing tissue including skin, hair, and/or nails.

Abstract: The present invention provides, among other things, compositions and methods for CNS delivery of lysosomal enzymes for effective treatment of lysosomal storage diseases. In some embodiments, the present invention includes a stable formulation for direct CNS intrathecal administration comprising an arylsulfatase A (ASA) protein, salt, and a polysorbate surfactant for the treatment of Metachromatic Leukodystrophy Disease.

Abstract: The present invention discloses an application of neuraminidase and inhibitors thereof in myocardial ischemia and myocardial infarction, provides a correlation between neuraminidase and myocardial ischemic damage to prove the myocardial ischemic damage can be alleviated by inhibiting the activity of neuraminidase, and to prove the neuraminidase can be used as a target for screening drugs for preventing, alleviating and/or treating myocardial ischemic damage. The present invention also demonstrates the alleviating effect of neuraminidase inhibitors on myocardial ischemic damage. Neuraminidase inhibitors improves myocardial ischemic damage by reducing the level of neuraminidase. The present invention further provides a pharmaceutical preparation comprising neuraminidase inhibitor(s) and pharmaceutically acceptable carrier(s), the pharmaceutical preparation can be used for reducing the level of neuraminidase, thus improving myocardial ischemic damage.

Abstract: The invention provides compositions and methods for effective lysosomal targeting mediated by SORT1. In particular, the compositions and methods provided by the invention may be used to treat lysosomal storage diseases such as Sanfilippo syndrome type B.

Abstract: Methods are provided for the prognosis, diagnosis and treatment of various pathological states, including cancer, chemotherapy resistance and dementia associated with Alzheimer's disease. The methods provided herein are based on the discovery that various proteins with a high level of sialylation are shown herein to be associated with disease states, such as, cancer, chemotherapy resistance and dementia associated with Alzheimer's disease. Such methods provide a lysosomal exocytosis activity profile comprising one or more values representing lysosomal exocytosis activity. Also provided herein, is the discovery that low lysosomal sialidase activity is associated with various pathological states. Thus, the methods also provide a lysosomal sialidase activity profile, comprising one or more values representing lysosomal sialidase activity. A lysosomal sialidase activity profile is one example of a lysosomal exocytosis activity profile.

Abstract: Variants of mannanase, compositions including the variants, to methods for their production and to methods of using the variants to degrade and modify mannan containing material.

Abstract: Compositions comprising deimmunized lysostaphin and methods of using the same, e.g., to treat microbial infection in or on a subject, are provided.

Abstract: The present invention provides composition and methods for diagnosis and treatment of lysosomal storage diseases and their diagnosis and treatment, including Gaucher's Disease and Tay-Sachs disease, and particularly which utilize progranulin (PGRN), or active PGRN peptides, including atsttrin. The invention also provides animal models of lysosomal storage diseases, including Gaucher's Disease and Tay-Sachs disease, based on or including PGRN mutations including PGRN null mutants and PGRN gene knock outs.

Abstract: The present disclosure provides compositions and methods for treating an infection by EV-D68. In particular, the present disclosure provides methods that entail administering agents having an anchoring domain that anchors the compound to the surface of a target cell, and a sialidase domain that can act extracellularly to inhibit infection of a target cell by EV-D68.

Abstract: Embodiments disclosed herein provide compositions for conjugates, including fusion proteins, and methods of using them to treat a variety of conditions. In some embodiments, the conjugates and/or fusion proteins incorporate a 60-amino acid human homeodomain (e.g., peptides derived from human HOX genes), to translocate functional and regulatory peptides and proteins or other biologically active molecules such as nucleic acids, which are not naturally associated with the human homeodomain, across cell and nuclear membranes to intended sites of action without provoking an unwanted immune response that may reduce exposure to the conjugate and/or result in a clinical adverse event. In further embodiments, disclosed conjugates and fusion proteins can pass through the blood-brain barrier to allow entry into the CNS.

Abstract: A method of producing collagen from hydrolyzed egg membrane includes combining 95% ethanol, cold water, a bacterial pH neutral protease and/or an alkaline bacterial protease, a pH neutral bacterial metalloendopeptidase, sodium bisulfite, and egg membrane. Once combined, the solution is mixed slowly and then heated to a desired pH range and temperature. Once a desired temperature is reached, the heated solution is set aside to digest for a prolonged period of time. Next, the digested solution is centrifuged and collected to form a filtered solution. Finally, the filtered solution is spray dried and packaged.

Abstract: Provided are methods for treatment of Fabry disease in a patient having renal impairment and/or elevated proteinuria. Certain methods comprise administering to the patient about 100 to about 150 mg free base equivalent of migalastat or salt thereof at a frequency of once every other day. Certain methods also provide for the stabilization of renal function, reducing left ventricular mass index, reducing plasma globotriaosylsphingosine and/or increasing ?-galactosidase A activity in the patient.

Abstract: Disclosed are methods of enhancing plant growth, comprising treating seed at least one month prior to planting with an effective amount of a plant signal molecule, wherein upon harvesting the plant exhibits at least one of increased plant yield measured in terms of bushels/acre, increased root number, increased root length, increased root mass, increased root volume and increased leaf area, compared to plants harvested from untreated seed, or compared to plants harvested from seed treated with the signal molecule just prior to or within a week or less of planting.

Abstract: Recombinant human alpha glucosidase (rhGAA) composition derived from CHO cells that contains a more optimized glycan composition consisting of a higher amount of rhGAA containing N-glycans carrying mannose-6-phosphate (M6P) or bis-M6P than conventional rhGAAs, along with low amount of non-phosphorylated high mannose glycans, and low amount of terminal galactose on complex oligosaccharides. Compositions containing the rhGAA, and methods of use are described.

Abstract: Disclosed are methods of enhancing plant growth, comprising treating plant seed or the plant that germinates from the seed with an effective amount of at least one chitooligosaccharide, wherein upon harvesting the plant exhibits at least one of increased plant yield measured in terms of bushels/acre, increased root number, increased root length, increased root mass, increased root volume and increased leaf area, compared to untreated plants or plants harvested from untreated seed.

Abstract: The present invention relates to polypeptides comprising an amino acid sequence exhibiting at least about 90% sequence identity with the sequence of SEQ ID NO: 1. Said polypeptides preferably degrade the peptidoglycan of Gram-negative bacteria, in particular of Pseudomonas and/or Campylobacter bacteria. In addition, the present invention relates to nucleic acids encoding such polypeptides, vectors comprising such nucleic acids, and corresponding host cells. Finally, the present invention relates to compositions comprising such polypeptides, nucleic acids, vectors, and/or host cells according to the present invention.

Abstract: Disclosed herein is the nucleotide sequence of the Chromobacterium subtsugae genome. Also provided are the nucleotide sequences of open reading frames in the C. subtsugae genome (i.e., C. subtsugae genes). In addition, the amino acid sequences of proteins encoded by the C. subtsugae genome are provided. Nucleic acids, vectors and polypeptides comprising the aforementioned sequences are also provided. Homologues, functional fragments and conservative variants of the aforementioned sequences are also provided. Compositions having pesticidal, bioremedial and plant growth-promoting activities comprising C. subtsugae genes and proteins, and methods for the use of these compositions, are also provided.

Abstract: A vector having an expression cassette having a hIDUA gene having a sequence of SEQ ID NO: 1 or a sequence at least about 95% identical thereto which encodes a functional human alpha-L-iduronidase is provided. The vector may be production vector or a rAAV8. Also provided are compositions containing these vectors and methods of treating MPSI and the symptoms associated with Hurler, Hurle-Scheie and Scheie syndromes.

Abstract: Provided herein is a thermoplastic elastomer hydrogel and methods of making such. The hydrogel comprises a glass formed from poly(styrene)-b-poly(ethylene oxide) in which the coronal chain end has been functionalized with photodimerizable groups (AB-photo) and a liquid medium at a concentration between about 32:1 and about 2:1 liquid medium/AB-photo by weight. The hydrogel has a fatigue resistance to at least 500,000 compression cycles.

Abstract: A system and methods for the delivery of oxygen through a body cavity of a subject using oxygen microbubbles. Through circulation of oxygen microbubbles through the body cavity, oxygen and carbon dioxide exchange may occur. Overall improvement in extending survival rate time during emergency situations caused by pulmonary or similar oxygen-intake restricting injury and/or failure may be achieved through use of the invented system and methods.

Abstract: A stable pharmaceutical composition that includes an active agent selected from 1-deoxynojirimycin, a pharmaceutically acceptable salt thereof, or a derivative thereof, and a buffer, wherein the stable pharmaceutical composition is capable of being parenterally administered to a human without deleterious health effects. Pompe disease is an example of a lysosomal storage disorder. Pompe disease is caused by a deficiency in the enzyme acid alpha-glucosidase (GAA). GAA metabolizes glycogen, a storage form of sugar used for energy, into glucose.

Abstract: The present disclosure provides variants of C-type natriuretic peptide (CNP), pharmaceutical compositions comprising CNP variants, and methods of making CNP variants. The CNP variants are useful as therapeutic agents for the treatment of diseases responsive to CNP, including but not limited to bone-related disorders, such as skeletal dysplasias (e.g., achondroplasia), and vascular smooth muscle disorders (e.g., restenosis and arteriosclerosis).