Abstract: The present invention provides combination therapy methods of treating proliferative diseases (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include, for example, radiation, surgery, administration of chemotherapeutic agents, or combinations thereof. Also provided are methods of administering to an individual a drug taxane in a nanoparticle composition based on a metronomic dosing regime.

Abstract: The present invention provides methods and compositions for treating pancreatic cancer in an individual who has been previously treated for pancreatic cancer (e.g., gemcitabine-based therapy) by administering a composition comprising nanoparticles that comprise a taxane and an albumin. The invention also provides combination therapy methods of treating pancreatic cancer (for example, in an individual who has been previously treated for pancreatic cancer) comprising administering to an individual an effective amount of a composition comprising nanoparticles that comprise a taxane and an albumin and another agent.

Abstract: Provided are method of generating a fiber from a globular protein such as albumin. Also provided are albumin fibers and fabrics and methods of using same for bonding a damaged tissue or for ex vivo or in vivo formation of a tissue.

Abstract: Asymmetric bifunctional silyl (ABS) monomers comprising covalently linked pharmaceutical, chemical and biological agents are described. These agents can also be covalently bound via the silyl group to delivery vehicles for delivering the agents to desired targets or areas. Also described are delivery vehicles which contain ABS monomers comprising covalently linked agents and to vehicles that are covalently linked to the ABS monomers. The silyl modifications described herein can modify properties of the agents and vehicles, thereby providing desired solubility, stability, hydrophobicity and targeting.

Abstract: This invention discloses water soluble pharmaceutical compositions including at least one therapeutically active substance and at least one compound selected from the sialoglycosphingolipids, the glycosphingolipids or a mixture of sialoglicosphingolipids and glycosphingolipids, in which at least one of the therapeutically active substances is a drug with hydrophobic characteristics. In particular, sterile compositions for i.v. administration, composed of nano-glycosphingolipids micelles or modified glycosphingolipids, which can be coated with albumin in a noncovalent form and which allow transport and controlled release of highly hydrophobic molecules are disclosed.

Abstract: The invention relates to nucleic acid aptamers having the ability to bind human SPARC protein (osteonectin) with specificity. The invention also relates to compositions including such aptamers, as well as methods of identifying such aptamers. The invention further relates to methods for using such aptamers in treating and diagnosing proliferative diseases such as, e.g., cancer.

Abstract: Human proIslet Peptides (HIP) and HIP analogs and derivatives thereof, derived from or homologous in sequence to the human REG3A protein, chromosome 2p12, are able to induce islet neogenesis from endogenous pancreatic progenitor cells. Human proIslet Peptides are used either alone or in combination with other pharmaceuticals in the treatment of type 1 and type 2 diabetes and other pathologies related to aberrant glucose, carbohydrate, and/or lipid metabolism, insulin resistance, overweight, obesity, polycystic ovarian syndrome, eating disorders and the metabolic syndrome.

Abstract: The invention provides methods for predicting or determining the response of a mammalian tumor to a chemotherapeutic agent and for treating a mammalian tumor comprising detecting and quantifying the SPARC protein or RNA in a sample isolated from the mammal. The invention further provides kit for predicting the response of a mammalian tumor to a chemotherapeutic agent, comprising a means for the isolation of protein or RNA from the tumor, a SPARC protein or RNA detection and quantification means, control RNAs, and rules for predicting the response of the tumor based on the level of SPARC protein or RNA in tumor.

Abstract: The invention provides methods for predicting or determining the response of a mammalian tumor to a chemotherapeutic agent and for treating a mammalian tumor comprising detecting and quantifying the SPARC protein or RNA in a sample isolated from the mammal. The invention further provides kit for predicting the response of a mammalian tumor to a chemotherapeutic agent, comprising a means for the isolation of protein or RNA from the tumor, a SPARC protein or RNA detection and quantification means, control RNAs, and rules for predicting the response of the tumor based on the level of SPARC protein or RNA in tumor.

Abstract: The invention provides anti-SPARC antibody-based techniques for predicting a response to chemotherapy.

Abstract: Catheters used for medical treatment, e.g., hemodialysis are filled with a locking solution, usually heparin between treatments. To prevent infections, antimicrobial or antibiotic substances have been used as locking solution alone or in combination with antithrombotic substances. It has been found that these locking solutions are rapidly washed out from the catheter tip. The invention describes a thixotropic gel that can be used as locking solution. Beneficial substances, e.g., antimicrobial or antibiotic substances can be added to the gel. A preferred antimicrobial substance is taurolidine alone or in combination with salicylic acid or one of its salts.

Abstract: A sterile pharmaceutical composition for parenteral administration of propofol, said composition comprising propofol, optionally albumin, and less than about 10% by weight solvent for propofol, wherein said composition is stored in a container having a closure wherein said closure is inert to propofol.

Abstract: Serial-solvent biomaterials are described. Embodiments include materials made in an organic solvent that are stripped of the solvent and used in a patient, where they imbibe water and form a hydrogel. These materials are useful for, among other things, delivering therapeutic agents, tissue augmentation, and radiological marking.

Abstract: The present invention relates to an oil-in-water emulsion comprising at least one mucomimetic polymer, at least one lipid of phospholipid type, at least one lipid other than the phospholipid, at least one stabilizing polymer, and a hydrophilic liquid, to an emulsion comprising an aqueous phase that contains at least one stabilizing polymer and at least one mucomimetic polymer, and an oily phase that contains at least one lipid of phospholipid type and a lipid other than the phospholipid, to a medicament comprising one of these emulsions, and to the use of one of these emulsions as an agent for restoring and/or replacing the lachrimal film or as a carrier for an active compound.

Abstract: The invention refers to an oral pharmaceutical tableted dosage form which comprises a mixture of: a) granules comprising ferrimannitol-ovalbumin (FMOA) and at least an intragranular pharmaceutical acceptable excipient including a binder; and b) extragranular pharmaceutical excipients including a filler and a binder; which may be obtained by wet-granulation and compression.

Abstract: Hydrogel compositions that include an albumin/N-acetyl cysteine solution and an aqueous suspension of calcium salts or mixture of calcium and magnesium salts are described. Also described are methods of producing and using the hydrogel compositions as a support scaffold for mineralizing connective tissue replacement and repair.

Abstract: The present invention provides methods and compositions useful in the regeneration of damaged, lost and/or degenerated tissue in humans and animals. In certain embodiments, the present invention provides an acellular bioabsorbable tissue regeneration matrix, methods of making such a matrix, and methods of using such a matrix for the regeneration of damaged, lost and/or degenerated tissue. In certain embodiments, methods and compositions of the present invention are useful in the treatment of damaged, lost and/or degenerated nerve tissue.

Abstract: Fibrillar human serum albumin was shown to be effective in the treatment of various types of cancers. Methods and compositions are disclosed for using fibrillar human serum albumin as a medicament to treat subjects having cancer.

Abstract: The present invention provides a telomerase activity inhibiting polypeptide. The expression of the polypeptide in tumor cells can inhibit significantly tumor cell telomerase activity, tumor cell growth, and lead to the death of such cells. The present invention further provides a preparation method for the polypeptide and an application thereof in targeted treatments of tumors.

Abstract: Methods of treatment using Fzd8 extracellular domains (ECDs), Fzd8 ECD fusion molecules, and/or antibodies that bind Fzd8 are provided. Such methods include, but are not limited to, methods of treating obesity and obesity-related conditions. Fzd8 ECDs and Fzd8 ECD fusion molecules are also provided. Polypeptide and polynucleotide sequences, vectors, host cells, and compositions comprising or encoding such molecules are provided. Methods of making and using Fzd8 ECDs, Fzd8 ECD fusion molecules, and antibodies that bind Fzd8 are also provided.

Abstract: A method of promoting hair growth of a subject includes administering to follicle cells of the subject a therapeutically effective amount of a TLR2 agonist that promotes TLR2 activation and hair growth of the subject.

Abstract: Nanocapsule compositions comprising a calcium carbonate core surrounded by a bilayer or bilayers of polystyrene sulfonate and poly(allylamine hydrochloride). The poly(allylamine hydrochloride) is conjugate to a substrate, wherein the substrate is capable of being acted upon (for example cleaved) by a biomarker or enzyme associated with a disease state of interest. The nanocapsule compositions may be administered to an animal, for example a human, for the treatment of a disease state.

Abstract: A kit for forming a biocompatible material provides a protein solution and a polymer solution including a derivative of a hydrophilic polymer with a functionality of at least three. Upon mixing. the protein solution and the polymer solution cross-link to form a non-liquid, three-dimensional network that degrades over time back to a liquid form. The polymer includes a degradation control region selected to achieve a desired degradation period and a cross-linking group selected to achieve a desired cross-linking period. The kit provides instructions for forming a mixture of the protein solution and polymer solution and for applying the mixture. The mixture serves as the foundation for multiple material composition species, each adapted to a specific therapeutic indication.

Abstract: A method of inhibiting cell migration or treating an inflammatory condition, comprising administering a compound disclosed herein to the subject, is provided. The compound can be administered systemically, locally, or a combination thereof. For example, the compound can be locally delivered from a temporary device or an implant, such as a vascular prosthesis.

Abstract: Certain embodiments of the invention include medical materials and methods comprising a biodegradable hydrophilic hydrogel comprising dispersed lipophilic particles that comprise a therapeutic agent, wherein the lipophilic particles have a low water solubility in physiological saline at physiological temperature.

Abstract: The invention features a powdered composition including a pharmaceutically active compound and a protein or a hydrolyzed protein. In particular, the powdered composition forms a stable solution or dispersion suitable for oral administration in which the protein or the hydrolyzed protein is bound to the pharmaceutically active compound. The invention also provides a method of administering the composition, such as to a patient with dysphasia; liquid or semi-solid formulations of the composition; methods for preparing the composition; and kits including the composition.

Abstract: The present invention provides a polypeptide comprising (i) a leader sequence, the leader sequence comprising a (a) secretion pre sequence, and (b) the following motif: -X1-X2-X3-X4-X5- where X1 is phenylalanine, tryptophan, or tyrosine, X2 is isoleucine, leucine, valine, alanine or methionine, X3 is leucine, valine, alanine or methionine, X4 is serine or threonine and X5 is isoleucine, valine, alanine or methionine; and (ii) a desired protein heterologous to the leader sequence. A polypeptide of the invention may additionally comprise, as part of the leader sequence, a secretion pro sequence. The invention also provides a polynucleotide comprising a sequence that encodes a polypeptide of the invention and a cell, preferably a yeast cell, comprising said polynucleotide.

Abstract: The present invention relates to a method of promoting hair growth comprising administering a fibroblast growth factor receptor 3 (FGFR3) extracellular domain (ECD), including native FGFR3 ECDs, variants, fragments, and fusion molecules, to a subject in an amount sufficient to promote hair growth.

Abstract: Provided are human serum albumin (HSA) compositions with improved properties over native HSA.

Abstract: The present invention provides combination therapy methods of treating a proliferative disease (such as cancer) comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a hedgehog inhibitor that inhibits a hedgehog signaling pathway.

Abstract: The present invention relates to a chitosan capsule in which a soluble active ingredient is encapsulated in a matrix containing chitosan and phytic acid; a cross-linking method and materials capable of being used in preparing the capsule; and pharmaceutical, food and cosmetic compositions comprising the capsule. The chitosan capsule according to the present invention is prepared via ionic gelation of chitosan as a biodegradable polymer with phytic acid capable of rapidly and effectively forming a cross-linking reaction with the chitosan polymer. The capsule of the present invention shows high encapsulation efficiency for a soluble active ingredient and protects the soluble active ingredient from being damaged in a digestive tract, resulting in improving an in vivo delivery efficiency of a physiologically active material.

Abstract: A method for treating conditions related to lack of blood supply with a lipid based resuscitation fluid is disclosed. The resuscitation fluid contains a lipid component and an aqueous carrier. The lipid component forms an emulsion with the aqueous carrier. The resuscitation fluid can be used to increase the blood pressure and to carry oxygen to tissues. The resuscitation fluid can also be used for preserving the biological integrity of donor organs for transplantation.

Abstract: The application discloses albumin derivatives comprising or consisting of domain III and at least one further domain wherein the derivative or variant is not a naturally occurring albumin derivative or variant. The derivatives may be used in conjugates and fusion polypeptides.

Abstract: Described herein are methods and compositions relating to treatment of tissue damage resulting from a central nervous system (CNS) hemorrhage with a protoporphyrin IX-Fe compound.

Abstract: The present invention provides methods and materials by which glycosylation of glycoproteins can be regulated. Methods include the monitoring and regulation of parameters such that a glycoprotein having a desired product quality is obtained.

Abstract: The invention relates to variants of a parent albumin having altered plasma half-life compared with the parent albumin. The invention also relates to fusion polypeptides and conjugates comprising said variant albumin.

Abstract: A method for inhibiting survival of cancer cells in a subject is disclosed. The method comprises administering to a subject in need thereof a therapeutically effective amount of fibrillar albumin. The preparation of the fibrillar albumin comprises: (i) forming a solution comprising an isolated and/or purified globular albumin; (ii) adding a detergent to the solution containing the isolated and/or purified globular albumin, wherein the detergent is one selected from the group consisting of sodium dodecyl sulfate (SDS) and n-tetradecyl-N,N-dimethyl-3-ammonio-1-propanesulfonate; (iii) applying the solution to a molecular sizing column with a pore size that permits separation of a protein with a molecular weight of at least about 70 kDa so as to promote column-induced formation of the fibrillar albumin from the isolated and/or purified globular albumin; and (iv) eluting the fibrillar albumin from the column, wherein the eluted albumin has a fibrillar structure.

Abstract: Methods are provided for suppressing cancer metastasis. Cancer metastasis is the most common cause of treatment failure and death in cancer patients. Tumor cell invasion and/or migration can be significantly inhibited after fibrillar proteins (rVP1, F-HSA, and F-BSA) treatment in vitro. In addition, rVP1 can significantly suppress murine and human breast cancer metastasis and human prostate and ovarian cancer metastasis in vivo while F-HSA can significantly suppress murine breast cancer metastasis. Compositions of fibrillar proteins as anti-cancer metastasis therapeutics and methods of use thereof are provided herein.

Abstract: The invention provides a method of treating T-cell mediated diseases and a method of inhibiting the activation of T-cells using certain diketopiperazines. The invention also provides methods of synthesizing diketopiperazines and pharmaceutical compositions comprising certain diketopiperazines. The invention further provides methods of making improved pharmaceutical compositions of proteins and peptides by either increasing or decreasing the content of diketopiperazines in the compositions and the resultant improved pharmaceutical compositions.

Abstract: Porous materials and methods for forming them are disclosed. One method for immobilizing micro-particles and/or nano-particles onto internal pore surfaces and/or external pore surfaces of porous materials includes suspending the micro-particles and/or nano-particles in a liquid adapted to swell, soften, and/or deform either the porous materials and/or the particles, thereby forming a liquid-particle suspension. The method further includes adding the suspension to the porous materials; and removing the liquid, thereby forming the porous materials having the micro-particles and/or nano-particles immobilized on the internal pore surfaces and/or the external pore surfaces.

Abstract: The present invention relates to compositions and methods for reducing cell proliferation and/or promoting cell death by inhibiting Drp1. It is based, at least in part, on the discoveries that (i) Drp1 disruption-induced mitochondrial hyperfusion is functionally linked to the cell cycle regulation apparatus, so that Drp1 inhibition results in a disruption of the cell cycle and DNA aberrancies; (ii) inhibition of both Drp1 and ATR are synthetic lethal causing increased DNA damage and apoptotic cell death; and (iii) even in resistant cell lines, Drp1 inhibitor (e.g., mdivi-1) together with a second antiproliferative agent (e.g., cisplatin or carboplatin) act synergistically to promote apoptosis. Accordingly, the present invention provides for novel anticancer strategies.

Abstract: Methods and compositions are provided that load and encapsulate an agent, such as a protein, in a porous self-healing polymer. A delivery system includes a porous self-healing polymer, an ionic affinity trap within the pores of the self-healing polymer, and an agent associated with the ionic affinity trap. Methods of encapsulating an agent in a polymer include providing a porous self-healing polymer comprising an ionic affinity trap within the pores. The polymer is incubated with an agent having an affinity for the ionic affinity trap. At least a portion of the pores in the polymer are then healed. Active encapsulation of macromolecules at low concentrations may be achieved due to affinity of the agent for the ionic affinity trap within the pores.

Abstract: The present invention relates to a fully synthetic albumin analog, to a hemocompatible coating for medical devices containing the fully synthetic albumin analog, as well as to medical devices coated with the hemocompatible coating. The albumin analog preferably has two basic structures which are connected with one another via at least one bridging unit, the basic structures respectively having, in a geometrically defined manner, at least two bound joint regions to which at least one residue is covalently bound, wherein the basic structures are, respectively, a benzene carboxylic acid, and wherein the joint regions are formed via acid amide bonds, and wherein each residue, respectively, comprises a lipophilic region and a hydrophilic region.

Abstract: The invention relates to proteins comprising angiogenesis inhibiting peptides, such as endostatin peptides (including, but not limited to, fragments and variants thereof), which exhibit anti-retroviral activity, fused or conjugated to albumin (including, but not limited to fragments or variants of albumin). These fusion proteins are herein collectively referred to as ‘albumin fusion proteins of the invention.’ These fusion proteins are herein collectively referred to as ‘albumin fusion proteins of the invention.’ These fusion proteins exhibit extended shelf-life and/or extended or therapeutic activity in solution. The invention encompasses therapeutic albumin fusion proteins, compositions, pharmaceutical compositions, formulations and kits.

Abstract: A tissue thickness compensator may generally comprise a first layer comprising a first medicament, a second layer comprising a second medicament, and a third layer comprising a third medicament. The tissue thickness compensator may comprise a first layer comprising a first medicament, a second layer comprising a second medicament, and a reservoir comprising a third medicament disposed within the reservoir. The medicaments may be independently selected from a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a pharmaceutically active agent, a matrix metalloproteinase inhibitor, and combinations thereof. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.

Abstract: The present invention encompasses albumin fusion proteins. Nucleic acid molecules encoding the albumin fusion proteins of the invention are also encompassed by the invention, as are vectors containing these nucleic acids, host cells transformed with these nucleic acids vectors, and methods of making the albumin fusion proteins of the invention and using these nucleic acids, vectors, and/or host cells. Additionally the present invention encompasses pharmaceutical compositions comprising albumin fusion proteins and methods of treating, preventing, or ameliorating diseases, disorders or conditions using albumin fusion proteins of the invention.

Abstract: The invention provides multiparametric anti-SPARC antibody-based techniques for predicting the response to therapy, including chemotherapy, radiotherapy, surgical therapy and combination therapies

Abstract: The invention provides a pharmaceutical composition that can be used for an efficient administration of a water-soluble polymer drug by a method other than injection, and a method for production of the pharmaceutical composition. The pharmaceutical composition contains a small particle comprised of (a) a water-soluble drug and (b) a pharmaceutically acceptable ionic crystalline compound which is solid at room temperature, wherein the ionic crystalline compound is crystallized in the small particle.

Abstract: The present invention provides a method for screening an agent being useful for the treatment of dry eye and/or corneal and conjunctival lesion of dry eye severity level 3 or more according to the report of the International Dry Eye WorkShop (DEWS Report) (2007) and a pharmaceutical composition comprising the agent. The present invention further provides a method for the treatment of dry eye and/or corneal and conjunctival lesion of dry eye severity level 3 or more according to DEWS Report (2007) using the agent.

Abstract: Nanocomposite fibers containing one or more carbon nanotubes encapsulated in an polysaccharide gel matrix.