Abstract: The patent provides a process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of: (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol; (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. up to 17.5° C. to produce a filtrate; and (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container. This patent further provides an aqueous pharmaceutical solution comprising 40 mg/ml glatiramer acetate and 40 mg/ml mannitol, wherein the aqueous pharmaceutical solution a) has a viscosity in the range of 2.0-3.5 cPa; or b) has an osmolality in the range of 275-325 mosmol/Kg. This patent also provides a prefilled syringe, an automated injector and a method of treatment of a human patient.

Abstract: The present disclosure provides peptides and constructs that inhibit mitochondrial fission, and compositions comprising the peptides or constructs. The present disclosure provides methods of reducing abnormal mitochondrial fission in a cell. Also provided are methods for designing and validating mitochondrial fission inhibitor constructs and peptides, including but not limited to, evaluating the effects of the constructs and peptides on binding of dynamin-1-related protein (Drp1) GTPase activity, Drp1 to mitochondrial fission 1 protein (Fis1), reduction of mitochondrial damage, reduction in cell death, inhibition of mitochondrial fragmentation in a cell under pathological conditions, and reduced loss of neurites in primary dopaminergic neurons in a Parkinsonism cell culture.

Abstract: The present invention relates to a composition for effectively treating cancer stem cells, and more specifically to a composition for treating cancer stem cells, which contains a glucose uptake inhibitor, a biguanide-based compound, and a calcium pump inhibitor. The composition of the present invention can be used as an agent of treating cancer stem cells by effectively inducing apoptosis of the cancer stem cells. Accordingly, the composition of the present invention can be used as a pharmaceutical composition capable of effectively treating various cancer stem cells to effectively inhibiting cancer recurrence and/or metastasis.

Abstract: Disclosed herein, in certain embodiments, are methods and compositions for treating inflammatory disorders. In some embodiments, the methods comprise co-administering synergistic combinations of modulators of inflammation.

Abstract: Disclosed are methods involving the therapeutic use of human PRG4 (PRG4) protein, to ameliorate the symptoms associated with allergies and/or respiratory infections.

Abstract: A method of treating a patient who has gastric cancer includes administering to said patient a composition containing a population of activated T cells that selectively recognize cells in the patient that aberrantly express a peptide. A pharmaceutical composition contains activated T cells that selectively recognize cells in a patient that aberrantly express a peptide, and a pharmaceutically acceptable carrier, in which the T cells bind to the peptide in a complex with an MHC class I molecule, and the composition is for treating the patient who has gastric cancer. A method of treating a patient who has gastric cancer includes administering to said patient a composition comprising a peptide in the form of a pharmaceutically acceptable salt, thereby inducing a T-cell response to the gastric cancer.

Abstract: The present invention is directed to a method of producing analgesia in a mammalian subject. The method includes administering to the subject an omega conopeptide, preferably ziconotide, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl 1, buprenorphine, and sufentanil, or its pharmaceutically acceptable salts thereof, wherein the ?-conopeptide retains its potency and is physically and chemically compatible with the analgesic compound. A preferred route of administration is intrathecal administration, particularly continuous intrathecal infusion. The present invention is also directed to a pharmaceutical formulation comprising an omega conopeptide, preferably ziconotide, an antioxidant, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl, buprenorphine, and sufentanil.

Abstract: A method for classifying patients at risk for cardiovascular disease, other chronic inflammatory diseases, cardiovascular and/or non-cardiovascular morbidity and mortality based on a risk assessment for lymphocyte activation gene 3 (LAG3) protein deficiency, and for mediating the risk using recombinant lymphocyte activation gene-3 or LAG3 mimetic as a companion therapeutic alone or in combination with a statin and/or an anti-hyperlipidemic drug. The risk assessment is two-prong, beginning with a qualitative determination whether a subject has or is predisposed to abnormal expression of inflammasomes, heightened risk for inflammation and/or to dysfunctional HDL, followed by a quantitative assay or genetic screen for a polymorphism that occurs in the coding sequence of the LAG3 gene. Given positive indication, recombinant LAG3 and/or LAG3 mimetic is used alone or in combination with the therapeutic use of a cholesterol mediating drug for treatment.

Abstract: In one embodiment, the invention provides methods of treating or preventing cancer, in particular aspects breast and/or prostate cancer, by administering to a subject in need thereof a therapeutically-effective amount of irisin and, optionally, one or more adjuvant therapies (e.g. synergistic co-administration of an additional anti-cancer agent or chemotherapy). Related pharmaceutical compositions, assays and kits are also provided.

Abstract: A pharmaceutical compound for the treatment of obesity related disorder that is a conjugate of myristic acid and a leptin-related peptide. Preferably, the leptin-related peptide is OB3 that has been D-substituted at Leu-4. The resulting conjugate significantly improved the pharmacokinetic profile of the leptin-related peptide by extending its half-life from less than one hour to as long as twenty-eight hours, depending on the route of delivery, increasing uptake, reducing the rate of plasma clearance, and enabling the minimal effective dose to be reduced several fold.

Abstract: Certain embodiments are directed to a formulation of a therapeutic agent, as well as a method of making such a formulation, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.

Abstract: The present invention relates a pharmaceutical formulation comprising a long-acting growth hormone for use in a method of treating growth hormone deficiency, wherein the long-acting growth hormone formulation is administered to a patient in a bracketed dosage regimen, to a multitude of unit dosage forms comprising a long-acting growth hormone formulation, wherein the unit dosage forms comprise increasing amounts of growth hormone equivalents and wherein the amount of growth hormone equivalents increases by at least 10% between one unit dosage form and the next higher dosage form; their use in a method of treating growth hormone deficiency and method of treating growth hormone deficiency in a bracketed dosing regimen.

Abstract: The present invention provides FAHD1 for use in a method for the treatment or prevention of aberrations of the energy metabolism of the nervous system, pancreas, kidney, liver, muscles or adipose tissue. Further, a method of decarboxylating an organic compound is provided, which uses FAHD1 to decarboxylate the organic compound. Additionally, a method and a kit for identifying inhibitors of FAHD1 are provided.

Abstract: The present invention relates to a fusion protein comprising an endolysin with an amino acid sequence according to SEQ ID NO: 1 and fragments and/or derivatives thereof and an additional cationic or polycationic peptide, an amphipatic peptide, a sushi peptide, a defensin, a hydrophobic peptide or an antimicrobial peptide fused to said endolysin, fragment and/or derivative at the N- and/or C-terminus. Moreover, the present invention relates to nucleic acid molecules encoding said fusion protein, vectors comprising said nucleic acid molecules and host cells comprising either said nucleic acid molecules or said vectors. In addition, the present invention relates to said fusion protein for use as a medicament, in particular for the treatment or prevention of staphylococcal infections, as diagnostic means, as cosmetic substance or as sanitizing agent.

Abstract: Compositions and methods to treat biofilms are disclosed based on the discovery of the role of the disaccharide trehalose in microbial biofilm development. In various embodiments to treat body-borne biofilms systemically and locally, the method includes administering trehalase, the enzyme which degrades trehalose, in combination with other saccharidases for an exposition time sufficient to adequately degrade the biofilm gel matrix at the site of the biofilm. The method also includes administering a combination of other enzymes such as proteolytic, fibrinolytic, and lipolytic enzymes to break down proteins and lipids present in the biofilm, and administering antimicrobials for the specific type(s) of infectious pathogen(s) underlying the biofilm. Additionally, methods are disclosed to address degradation of biofilms on medical device surfaces and biofilms present in industrial settings.

Abstract: Microparticle formulations of a sialidase fusion protein are produced by contacting an aqueous solution of a protein or other active agent with an organic solvent, a counterion and a scavenging agent, and chilling the solution. The microparticles are useful for preparing stable, uniform pharmaceuticals of predetermined defined dimensions.

Abstract: Methods for treating cancers, such as breast cancer or skin cancer, using an ACE or ARB, or a combination of celecoxib and olmesartan.

Abstract: This disclosure provides therapeutic compositions and methods for treating multiple sclerosis or a multiple sclerosis-related disorder in a subject in need thereof comprising administering an effective amount of an antigen-MHC-nanoparticle complex to the subject, wherein the antigen is a multiple sclerosis-related antigen.

Abstract: The present invention provides compositions comprising peptide-coupled biodegradable poly(lactide-co-glycolide) (PLG) particles. In particular, PLG particles are surface-functionalized to allow for coupling of peptide molecules to the surface of the particles (e.g., for use in eliciting induction of immunological tolerance).

Abstract: The present description relates to T-cell receptors (TCRs) binding to tumor-associated antigens (TAAs) for targeting cancer cells, T-cells expressing same, methods for producing same, and methods for treating cancers using same. In particular, the present description relates to TCRs and their variants that bind to HLA class I or II molecules with a peptide, such as IGF2BP3-001 have the amino acid sequence of KIQEILTQV (SEQ ID NO:1). The present description further relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present description relates to the immunotherapy of cancer. The present description furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T-cells ex vivo and transfer into patients.

Abstract: Systems and methods are presented that allow for selection of tumor neoepitopes that are then used to generate a recombinant polytope that is optimized for proper trafficking and processing. In preferred methods, the polytope is encoded in a viral expression system that is used as a therapeutic agent.

Abstract: Disclosed in the present invention is micellar polypeptide vaccine having pegylated phospholipid as carrier. The vaccine can prevent or treat tumors or can be used as combination formulation with anti-cancer activity formulation. The micellar polypeptide vaccine is formed of self-assembling pegylated phospholipid (PEG-PE) and antigenic polypeptides, the pegylated phospholipid being compound formed of polyethylene glycol (hydrophilic blocks) covalently bonded to nitrogenous bases on phospholipid molecule (hydrophobic blocks). The particle diameter of the micellar vaccine is 10-100 nm, and the antigenic polypeptides carried therein are polypeptides of 5-100 amino acids. The micellar polypeptide vaccine may also contain immunoadjuvant.

Abstract: The invention provides a bioactive peptide including a partial amino acid sequence of Plasmodium falciparum enolase, and having a molecular structure compatible with a specification setting for a GMP-compliant production process. The peptide has a structure in which two peptides, each having an amino acid sequence of A01-Ala-Ser-Glu-Phe-Tyr-Asn-Ser-Glu-Asn-Lys-Thr-Tyr-Asp-Leu-Asp-Phe-Lys-Thr-Pro-Asn-Asn-Asp-A02 (SEQ ID NO: 1) or A03-Ala-Ser-Glu-Phe-Tyr-Asn-Ser-Glu-Asn-Lys-Thr-Tyr-Asp-Leu-Asp-Phe-Lys-Thr-Pro-Asn-Asn-Asp-Lys-Ser-Leu-Val-Lys-Thr-A04 (SEQ ID NO: 2) are linked by amide bonds between the respective carboxy termini of the two peptides and two amino groups of Lys in a linker peptide represented by Lys-A05-Cys-A06 and arranged in the form of a two-forked branch, wherein each of A01 to A06 represents an amino acid residue in a number of an arbitrary number including 0.

Abstract: The present application generally relates to the development of a vaccine, or the production of antibodies, capable of providing improved protection against a virus associated with ADF, such as Zika, Dengue and Ebola, based on novel antigenic peptides identified using an informational spectrum method (ISM).

Abstract: A method for predicting whether a patient will be a long-term survivor on treatment of a disease by adoptive cell transfer (ACT), is disclosed comprising: (i) analysing a blood-derived sample obtained from the patient for one or more prognostic markers of long-term survival on treatment of a disease by ACT, and; (ii) based on the analysis of step (i), predicting whether the patient will be a long-term survivor on treatment of the disease by ACT. Also disclosed are methods for treating a patient by ACT, methods for selecting a patient for treatment by ACT, and methods for selecting a patient for treatment of a disease by ACT.

Abstract: The invention is directed to methods of modulating an immune response in an animal, comprising administering a composition comprising one or more soluble CD1d complexes, in particular non-specific soluble CD1d complexes. Soluble CD1d complexes comprise a soluble CD1d polypeptide, a ?2-microglobulin polypeptide, and a ceramide-like glycolipid antigen bound to the CD1d antigen binding groove, and in certain embodiments, an immunogen. The administration of compositions of the present invention affects the activity of CD1d-restricted NKT cells, and in particular, allows for multiple administrations without causing CD1d-restricted NKT cell anergy.

Abstract: Improved methods for the manufacture of pharmaceutical compositions comprising at least one surfactant, involving prefiltration of the surfactant prior to formulation into final products.

Abstract: The present invention provides methods of regulating an immunological disorder comprising administering to a subject an effective amount of (i) an autoimmune antigen in conjunction with (ii) an anti-inflammatory cytokine. Compositions including the same are also provided.

Abstract: The present invention provides methods for treating patients suffering from familial hypercholesterolemia, including both HeFH and HoFH. The methods of the invention provide for lowering at least one lipid parameter in the patient by administering a therapeutically effective amount of an antibody or antigen-binding fragment thereof that specifically binds to ANGPTL3 in combination with a therapeutically effective amount of a statin, a first lipid lowering agent other than a statin, and a second lipid lowering agent other than a statin. The first non-statin lipid lowering agent is an agent that inhibits cholesterol uptake (e.g. ezetimibe) and the second non-statin lipid-lowering agent is an inhibitor of microsomal triglyceride transfer protein (e.g. lomitapide).

Abstract: The present invention relates to a method of treating patients suffering from cancers driven by deregulated Human Epidermal Growth Factor Receptor (HER/Human EGFR), wherein an irreversible tyrosine kinase inhibitor (TKI) is administered according to a continuous regimen based on an average daily dose in the range of 10 to 50 mg and the mAB is co-administered according to a dosing regimen ranging from an average weekly iv dose of 50 to 500 mg/m2 repeated thrice, twice or once a week, once in two weeks, once in three weeks or at least monthly to a patient in need of such treatment.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: Methods for the generation of electrochemical plasma activated aqueous chemotherapeutics (EPAAC) solutions are described. These solutions have been found to selectively reduce the proliferation of human pancreatic cancer cells, with no toxic effects for healthy cells.

Abstract: Disclosed are a multifunctionalized polyethylene glycol derivative and a preparation method therefor. The derivative has an H-shaped structure as represented by formula (1) and comprises one linear core LPEG and four PEG branch chains, where n1, n2, n3, and n4 respectively are the degrees of polymerization of the branch chains, U1 and U2 are trivalent branching groups connecting the core LPEG to two of the PEG branch chains, F1 and F2 contain a functional group or a protected form R01 thereof and may or may not contain a branched group G, correspondingly, the number of R01 is one or more, F1 and F2 are either identical or different, any one linking group in the molecule or any linking group formed with an adjacent heteroatom group can either remain stable or be degraded, and any one PEG segment in the molecule is discretely polydispersed or monodispersed.

Abstract: The present invention relates to a heat-sterilized aqueous composition comprising a solubilized chitosan and glycerol. It also relates to a process of preparation of the same, as well as the use thereof, including compositions useful for the prevention and treatment of dry eye syndrome and arthritic diseases or disorders.

Abstract: Nanostructures for the systemic delivery of nucleic acids, such as RNA, are provided herein. The nanostructures include templated lipoprotein nanoparticles (TLPs) composed of a core decorated with proteins, a lipid bilayer and hydrophobic molecules that self-assemble with nucleic acids, such as RNA. The nanostructures are useful for research, therapeutic and diagnostic applications.

Abstract: The present invention includes a method of treating a drug-induced atrioventricular (AV) block comprising: providing a subject in need of therapy a drug that is contraindicated to treat a disease or condition in the subject, wherein the drug causes an AV block, with an amount of a lipid sufficient to reduce or eliminate the AV block caused by the drug.

Abstract: Provided herein are branched oligonucleotides exhibiting efficient and specific tissue distribution, cellular uptake, minimum immune response and off-target effects, without formulation.

Abstract: Hydrogels that degrade under appropriate conditions of pH and temperature by virtue of crosslinking compounds that cleave through an elimination reaction are described. The hydrogels may be used for delivery of various agents, such as pharmaceuticals.

Abstract: Provided herein are amphiphilic polymers compositions for making aqueous formulations. In one aspect, a solution composition for delivery and release of active ingredients comprises a block co-polymer having formula: PEG-PCL-PLA-PCL-PEG or PGA-PCL-PEG-PCL-PGA or PLA-PCL-PEG-PCL-PLA or PCL-PLA-PEG-PLA-PCL or PCL-PGA-PEG-PGA-PCL. The block co-polymers are biodegradable, stable and compatible with hydrophilic, hydrophobic, and combinations thereof, biologic or chemical active agents. In some embodiments, the block co-polymers enable sustained and/or continuous release of various active agents. In certain embodiments, the block co-polymers can be used to make an artificial tear preparation, a lubricant for joints or wound cover or adhesive.

Abstract: A nanogel comprising a self-organizing peptide, a chitosan, and polyethylene glycol.

Abstract: The present invention relates to virus-like particles of plant virus Cucumber Mosaic Virus (CMV), and in particular to modified VLPs of CMV comprising Th cell epitopes, in particular universal Th cell epitopes. Furthermore, these modified VLPs serve as, preferably, vaccine platform, for generating immune responses, in particular antibody responses, against antigens linked to said modified VLPs. The presence of the Th cell epitopes, in particular universal Th cell epitopes, led to a further increase in the generated immune response.

Abstract: Nanoscale, pH-responsive polycationic networks useful for the delivery of anionic biologic therapeutics and associated methods.

Abstract: The present invention relates to improved therapies for the treatment of heart disease, particularly the improved delivery of therapeutic agents to heart tissue by direct infusion into the coronary circulation. A preferred embodiment of the invention is a method of treating or preventing a cardiovascular disease by transfecting cardiac cells of a large mammal, the method comprising, identifying a mammal in need of treatment or prevention of heart disease, supplying NO to the coronary circulation prior to, and/or during the infusion of a therapeutic polynucleotide into a blood vessel of the coronary circulation in vivo, where the therapeutic polynucleotide is infused into the blood vessel over a period of at least about three minutes, where the coronary circulation is not isolated or substantially isolated from the systemic circulation of the mammal; and where the therapeutic polynucleotide transfects cardiac cells of the animal resulting in the treatment or prevention of the heart disease.

Abstract: The present invention provides a magnetic graphene-like nanoparticle or graphitic nano- or microparticle. The magnetic graphene-like nanoparticle or graphitic nano- or microparticle of the invention exhibits a high relaxivity, and is useful as a MRI contrast agent. The present invention also provides a composition for use with MRI imaging, comprising a sufficient amount of the magnetic graphene-like nanoparticles or graphitic nano- or microparticles and one or more physiologically acceptable carriers or excipients. The present invention also provides methods of using the magnetic graphene-like nanoparticles or graphitic nano- or microparticles as MRI contrast agents. The present invention further provides methods of producing the magnetic graphene-like nanoparticle or graphitic nano- or microparticle.

Abstract: The present invention describes processes for the preparation of a lipid blend and a uniform filterable phospholipid suspension containing the lipid blend, such suspension being useful as an ultrasound contrast agent.

Abstract: According to the hydrogen peroxide plasma ionization generator device having a double-jet nozzle suggested by the present invention, the double jet nozzle forming an air passage is configured to construct the hydrogen peroxide plasma ionization generator device such that the hydrogen peroxide and ion particles are sprayed finer than that of a conventional single-jet nozzle.

Abstract: The sterilizing tool is configured to wipe debris from and to sterilize and/or dry a working end-site of medical device; using a wiping, twisting, dabbing, push/pull, and/or screwing motion around all of the surface aspects of the device to be sterilized. Additionally, the sterilizing tool is configured to form fit to the surfaces of the end-site and to apply an inclusive layer of an anti-pathogenic agent to the inner and outer surfaces of the working end-site. The sterilizing tool may be frictionally engaged with and retained on the working end-site until removed and the end-site is ready for use. The sterilizing tool is intended for a one time, single use, disposable application.

Abstract: A process and device for the sterilization/disinfection with ozone and it is based on the hydrogen peroxide or other chemicals vapor injection that humidifies the load inside the chamber and transports the ozone through multiple capillaries into the chamber. Said Ozone sterilization or disinfection device with hydrogen peroxide vapor injection vaporizes and combines hydrogen peroxide or other chemicals with ozone in the capillaries in a vaporizer/mixer that feeds a sterilization/disinfection chamber, said feeding being made with a dose varying; the vaporizer/mixer working with a pressure between 0.0001 mbar and 3000 mbar ABS and heated by an automatic and/or electrical system, or by a micro-wave system at a temperature of 5° C. to 200° C.; the vaporization process being made to a sterilization/disinfection chamber at a pressure between 0.0001 mbar and 3000 mbar ABS is made drop by drop by capillary tubes, which transform the liquid into a pulverized gas combined with ozone.

Abstract: Systems are disclosed which include processor-executable program instructions for receiving data regarding characteristics of a room and determining, based on the received data, operating parameter/s for one or more disinfection sources to disinfect the room. The data may include data regarding non-physical characteristics and/or physical characteristics of the room. In some embodiments, data regarding a quantity and/or type of at least a subset of the plurality of disinfection sources for disinfecting the room may also be considered for determining the operating parameter/s. In any case, the determined operating parameter/s may include a run time of a disinfection source, a position of a disinfection source within the room, a speed at which a disinfection source moves throughout the room, an orientation of a component comprising a disinfection source, a rate of germicidal discharge from a disinfection source and/or power supplied to a disinfection source.

Abstract: A scent dispenser is provided which comprises a cylinder having a cylinder chamber for receiving a hollow piston which includes a piston body that is closely fitted to the cylinder chamber and is slideable therein, upward to a fully extended position and downward to a fully compressed position. The piston body also includes a cylindrical piston chamber having an opening at a bottom end of the piston body, which body is sized and shaped to receive a scent cell therein. The piston further includes a cover attached to or integral with an upper end of the piston body. The scent cell may be in the form of a substrate of nonwoven fibrous material capable of allowing air to flow readily through the scent cell and through a volatile scented substance contained therein. The scent cell may further comprise a coating material capable of reversibly absorbing or adsorbing the volatile scented substance, while allowing air to flow readily through the scent cell.