Abstract: The present invention relates to compositions and methods for preventing, treating or delaying various cardiovascular diseases or disorders in mammals, particularly in humans. More particularly, the present invention provides for compositions and methods for preventing, treating or delaying various cardiovascular diseases or disorders using, inter alia, a neuregulin protein, or a functional fragment thereof, or a nucleic acid encoding a neuregulin protein, or a functional fragment thereof, or an agent that enhances production and/or function of said neuregulin.

Abstract: Pharmaceutical compositions and methods for delivering a polypeptide to the central nervous system of a mammal via intranasal administration are provided. The polypeptide can be a catalytically active protein or an antibody, antibody fragment or antibody fragment fusion protein. The polypeptides are formulated with one or more specific agents.

Abstract: Embodiments of the invention are directed to use of neuregulins to prevent or treat peripheral nerve injury, to attenuate, ameliorate or avoid the loss of peripheral nerve function.

Abstract: Compositions and methods for repairing a ruptured connective tissue are disclosed. The composition may include a first biocompatible material to provide a scaffold for connective tissue cell growth and tissue repair. This first biocompatible material may withstand a tensile load of up to 250 N. The composition may also include a second biocompatible material including at least one bioactive agent that can stimulate connective tissue cell growth and tissue repair. The method may include positioning a first end of the first biocompatible material adjacent a first end of a ruptured connective tissue, positioning a second end of the first biocompatible material adjacent a second end of the ruptured connective tissue, and anchoring the first biocompatible material to the first and second tendon ends. The method may alternatively comprise or further include positioning a second biocompatible material between the first and second ends of the ruptured connective tissue.

Abstract: A system and method for producing a scaffold coated and/or impregnated with at least one bioactive agent. This is accomplished by culturing at least one cell in the same medium as a scaffold, but without physical contact between the at least one cell and the scaffold. The system includes a container having a surface defining an interior compartment. A medium is disposed within the interior compartment. At least one cell is disposed within the medium, the at least one cell being capable of producing at least one bioactive agent. Further, a scaffold is disposed within the medium. The scaffold is physically separated from the at least one cell such that there is no contact between the scaffold and the at least one cell. Thus, as the at least one cell produces at least one bioactive agent, such as a growth factor, the at least one bioactive agent enters the medium, and contacts and coats and/or impregnates the scaffold.

Abstract: Methods for promoting osteogenesis to accelerate or enhance bone fracture healing, treat bone defects, and enhance bone formation are disclosed. The methods rely on in vivo or ex vivo modulation of an arachidonic acid metabolic or signaling pathway in general, and, in particular, utilize 5-lipoxygenase inhibitors, leukotriene A4 hydrolase inhibitors, and/or leukotriene B4 receptor antagonists. These molecules can be delivered alone or in combination with one or more agents that inhibit bone resorption, regulate calcium resorption from bone, enhance bone accumulation, enhance bone formation, induce bone formation, impair growth of microorganisms, reduce inflammation, and/or reduce pain.

Abstract: A method of making and using a monolithic alginate implant is described. The implant is formed by providing an uncrosslinked, highly pure and high molecular weight alginate solution and injecting the alginate solution into a patient at a predetermined site to form a gel body comprising the monolithic alginate implant. Spontaneous crosslinking of the monolithic alginate implant occurs at the predetermined site without the addition of an exogenous crosslinker. The implant may be used for treating medical conditions requiring support of sphincter musculature, reconstructive surgery, or cosmetic reconstruction, for the treatment of wrinkles on the hand, face, or décolleté, or for increasing volume, for example in the case of (HIV-induced) lipoatrophy of the breasts, and for the treatment of selected diseases, including gastrooesophageal reflux disease, urinary incontinence or vesicoureteral reflux disease.

Abstract: A polyethylene glycol (PEG) aerogel particles having an average particle diameter not substantially above about 2?, a volumetric porosity of greater than about 50%, and pore sizes capable of retaining drug molecules. A method for preparing such polyethylene glycol (PEG) aerogel particles includes initiating a catalyzed reaction using a catalyst of PEG forming ingredients to form PEG particles; partially drying the formed PEG particles under conditions to control pore size; and subjecting the partially dried formed PEG particles to CO2 supercritical extraction for form the PEG aerogel particles. Drug molecules include chemotherapeutic agents. The surface of the PEG aerogel particles are reactable with a variety of agents, for example, to selectively target tumors, protects irreversible damage to labile proteins, and protects degradation of sensitive drugs with subsequent loss of biological efficacy.

Abstract: The present invention is directed to treatment methods for a disease or condition, in a subject in need of such treatment, that provide alternatives to treatment by injection that give, relative to treatment by injection, improved treatment outcomes, 100% treatment compliance, reduced side effects, and rapid establishment and/or termination of substantial steady-state drug delivery. The method typically includes providing continuous delivery of a drug from an implanted osmotic delivery device, wherein substantial steady-state delivery of the drug at therapeutic concentrations is typically achieved within about 7 days or less after implantation of the osmotic delivery device in the subject and the substantial steady-state delivery of the drug from the osmotic delivery device is continuous over a period of at least about 3 months. In one embodiment, the present invention is directed to treatment of type 2 diabetes mellitus using incretin mimetics.

Abstract: Improved biodegradable and bioabsorbable BAB-block copolymers exhibiting reverse thermal gellation properties, and aqueous polymer compositions including the BAB-block copolymers, are provided. Methods of making the improved BAB-block copolymers and compositions including the same are also provided.

Abstract: The invention relates to compositions and methods for treating or preventing vascular dementia in a mammal comprising mucosal administration of an amount of E-selectin polypeptide sufficient to induce bystander immune tolerance in the mammal. Another aspect of the invention relates to compositions useful for treating or preventing vascular dementia.

Abstract: The invention generally relates to methods and compositions for treating dry eye and related conditions by administering compositions comprising compounds that increase capillary permeability of either the lacrimal gland, accessory lacrimal gland, or ocular surface.

Abstract: Catheter injectable depot compositions are provided that include a bioerodible, biocompatible polymer, a solvent having miscibility in water of less than or equal to 7 wt. % at 25° C., in an amount effective to plasticize the polymer and form a gel therewith, a thixotropic agent, and a beneficial agent. The solvent comprises an aromatic alcohol, an ester of an aromatic acid, an aromatic ketone, or mixtures thereof. The compositions are have substantially improved the shear thinning behavior and reduced injection force, rendering the compositions readily implanted beneath a patient's body surface by injection.

Abstract: The present invention provides methods and compositions for sequentially and separately reducing infection and/or inflammation and regenerating tissue at a lesion site, by contacting the lesion site with a biodegradable scaffold that first delivers one or more agents at the lesion site to reduce infection and/or inflammation and then delivers one or more agents to regenerate tissue at the lesion site after inflammation is reduced.

Abstract: Fragments of CXCL12 Gamma A chemokine having improved chemotaxis activity in vivo defined by an unprecedented capacity to associate and immobilise on extracellular glycans.

Abstract: The present disclosure relates to a clottable concentrate of platelet growth factors for therapeutic and/or cosmetic use, preferably comprising the growth factors PDGF, TGT-?, IGF, EGF, CTGF, bFGF and VEGF. In a preferred embodiment, the clottable concentrate of platelet growth factors does not induce blood cell-related transfusion reactions. The present disclosure also relates to a method for preparing a clottable concentrate of platelet growth factors including the steps of contacting a platelet concentrate with a solvent and/or a detergent, incubating the platelet concentrate with the solvent and/or detergent for a period of at least 5 minutes to 6 hours, at a pH maintained in a range from about 6.0 to about 9.0, and at a temperature within the range of from 2° C. to 50° C., preferably within the range of from 25° C. to 45° C., and removing the solvent and/or the detergent by oil extraction and/or chromatographic means.

Abstract: The present invention provides a recombinant fusion protein which stimulates the rejuvenation and reactivation of skin and epidermal cells for improving skin appearance, smoothing wrinkles and freckles, and whitening skin. Particularly, the present invention provides various types of products for improving skin, which contain recombinant fusion protein of human serum albumin (HSA) with cytokine peptides (EGF, FGF, KGF, HGH, HGF, PDGF, GCSF, interferon, IL-11 or IGF) by genetic engineering technology. The fusion protein can be used independently or in a combination or combination with yeast fermentation products, or with varied emulsifiers, thickeners, moisturizer, preservatives, yeasts and ferments.

Abstract: A sustained-release drug composition consisting essentially of microparticles of hyaluronic acid having a high molecular weight or an inorganic salt thereof and a protein or peptide drug encased in said microparticles, wherein the average size of said microparticles ranges from 0.1 to 40 ?m.

Abstract: A novel etiological hypothesis for Multiple Sclerosis (MS) is proposed describing autoimmune attack of ATP: Cob (I) alamin adenosyltransferase (ATR) thereby inhibiting synthesis of (5?-deoxy-5?-adenosyl) cobamide (referred to as 5?-deoxyadenosylcobalmin or AdoCbl) from Vitamin B12 providing a basis for therapeutic design and diagnostic methods. Pharmaceutical compositions for therapy of MS, inflammatory neurological diseases and neurodegenerative diseases utilizing AdoCbl, growth hormone, immunomodulators, interleukins, other therapeutic agents, and physiotherapy are described. Encompassed in embodiments are diagnostic and therapeutic methods based on the amino acid sequence which binds AdoCbl in ATR. A scoping experiment in therapy, parenteral injection of AdoCbl, has been accomplished with a clinically definite MS patient in the Secondary Progressive stage of MS. The dramatic improvement in the patient's condition strongly supports the etiological hypothesis.

Abstract: The present invention provides compositions comprising isolated elastin and a pharmaceutically acceptable carrier wherein the human elastin is substantially insoluble in water with a molecular weight greater than 100 kDa. The present invention further provides methods and kits for soft tissue augmentation.

Abstract: Compositions and methods are provided that are useful for the delivery of therapeutic agents, including nucleic acids. The compositions can be prepared with components useful for targeting the delivery of the compositions as well as imaging components.

Abstract: Nanodevice and method for in vivo monitoring and release of drugs are provided. The disclosed nanodevice is characterized in having a drug-loaded nanosphere that is capable of releasing the encapsulated drugs upon magnetically stimulation. The nanodevice may also be used as a contrast agent for in vivo imaging and monitoring the concentration and distribution of the released drugs and/or active compounds injected separately into a target site of a subject.

Abstract: Cripto, a developmental oncoprotein, antagonizes activin and TGF-b signaling by forming a complex with activin and TGF-b and their type II receptors. This complex precludes the formation of a functional activin/TGF-b•type II•type I complex, thereby blocking the signaling of activin and TGF-b. Cripto may be generally capable of blocking antiproliferative Smad2/3 signals and provides a novel mechanism of oncogenic action with multiple therapeutic implications. Inhibiting the formation of Cripto and activin/TGF-b complex may enhance antiproliferative effects of activin and TGF-b.

Abstract: The present invention provides methods, compositions, and systems for treating a subject at risk for, with, or suspected of having, myocardial ischemia using hepatocyte secretory factors (e.g., AGP2, BMPER, FGF21, NRG4, and/or TFF3) or using factors that promote liver cell migration to ischemic myocardial tissue (e.g., IL-6 and/or MMP-2).

Abstract: The present invention provides a method for prophylaxis and therapy of infectious diseases caused by microorganisms present in biofilms adherent to cell surfaces comprising the step of administering to an individual in need thereof a composition comprising a combination of at least one compound chosen from the group of peroxidase, lactoferrin, lactoferrin peptides, lysozyme and immunoglobulins and at least one growth factor.

Abstract: The invention provides compositions (e.g., pharmaceutical compositions) comprising nucleic acids encoding the serine/threonine kinase PIM-1, and methods for making and using them; including methods for inducing cellular proliferation, and protecting cardiac cells from hypoxia and cellular apoptosis. The invention provides compositions (e.g., pharmaceutical compositions) comprising nucleic acids encoding PIM-1, and methods for enhancing the regenerative potential of stem cells in the heart.

Abstract: The subject invention pertains to compositions and methods for promoting repair of damaged nerve tissue. The compositions and methods of the subject invention can be employed to restore the continuity of nerve interrupted by disease, traumatic events or surgical procedures. Compositions of the subject invention comprise one or more chondroitin sulfate proteoglycan (CSPG)-degrading enzymes that promote axonal penetration into damaged nerve tissue. The invention also concerns methods for promoting repair of damaged nerve tissue using the present compositions and nerve tissue treated according to such methods. The invention also pertains to kits for nerve repair.

Abstract: Thrombospondin 1 (TSP-1), TSP-2, interleukin 17B receptor (IL-17BR) and heparin-binding epidermal growth factor-like growth factor (HB-EGF) associated with stem cell activity and use thereof.

Abstract: Isolated protein complexes are provided comprising growth factors such as IGF-I, IGF-II, EGF, bFGF, KGF, VEGF or PDGF, or at least domains thereof that enable binding to and activation of both a growth factor receptor, and an integrin receptor-binding domain of vitronectin or fibronectin. These protein complexes may be in the form of oligo-protein complexes or single, synthetic proteins where the growth factor and vitronectin or fibronectin sequences are joined by a linker sequence. In particular forms, vitronectin or fibronectin sequences do not include a heparin binding domain and/or polyanionic domain. Also provided are uses of these protein complexes for stimulating or inducing cell migration and/or proliferation which may have use in wound healing, tissue engineering, cosmetic and therapeutic treatments such as skin replacement and skin replenishment and treatment of burns where epithelial cell migration is required.

Abstract: Described, in certain aspects of the invention, are multilaminate medical graft products, as well as methods for preparing and using the same. An illustrative multilaminate medical graft product of the invention comprises a first layer of remodelable extracellular matrix (ECM) material bonded to a second layer of remodelable ECM material, wherein the first material layer is enriched with a growth factor relative to the second material layer. Such a remodelable ECM material may be comprised of submucosa from a warm-blooded vertebrate, for example, porcine small intestinal submucosa (SIS).

Abstract: Maternal diabetes can lead to a developmental malformation of an embryo. A developmental malformation caused by maternal diabetes is commonly referred to as a diabetic embryopathy. There is currently no effective treatment for reducing or inhibiting a diabetic embryopathy. To this end, the present invention is drawn to novel methods of treating a diabetic embryopathy.

Abstract: The present invention relates to a composite hydrogel comprising a blend of an aqueous solution of an anionic polysaccharide or a derivative thereof, such as hyaluronan (also commonly referred to as hyaluronic acid) or a derivative thereof and an aqueous solution of methylcellulose or another water soluble cellulose derivative thereof, having dispersed polymeric particles, such as polymeric hydrophobic particles therein selected from micro particles and nanoparticles, and wherein the stability of the hydrogel is enhanced relative to the stability of the hydrogel alone. The polymeric particles may contain at least one therapeutic agent, in which case each therapeutic agent exhibits a linear sustained release rate that can be tuned or altered by selecting the appropriate polymer formulation of the micro particles and/or nanoparticles.

Abstract: Methods of reducing and/or protecting against disorders in perinatal subjects are disclosed. Such methods can be used for disorders associated with neuronal cell damage. In certain aspects, the method comprises administering a therapeutically effective amount of neuregulin or a biologically active analog with a pharmaceutical carrier to a perinatal subject. In addition, the perinatal subject can be a fetus where the neuregulin is administered to the pregnant mother. Methods for assessing whether a perinatal subject is at risk for developing a neurological disorder are also disclosed. For example, expression levels of neuregulin can be used as an indication the perinatal subject is at risk for developing a disorder associated with neuronal cell damage. Evaluating the genotype of the NRG locus in a perinatal subject can also be used as an indicator of the risk of developing neurological disorders.

Abstract: The invention provides compositions and method for delivering a therapeutic or diagnostic agent to a disease site in a mammal, the method comprising administering to the mammal a therapeutically or diagnostically effective amount of a pharmaceutical composition, wherein the pharmaceutical composition comprises the therapeutic or diagnostic agent coupled to a Procaspase 8 polypeptide and a pharmaceutically acceptable carrier.

Abstract: The invention features methods of treating or preventing congestive heart failure by administering a polypeptide containing an epidermal growth factor-like domain encoded by a neuregulin gene.

Abstract: The present invention relates to graft copolymers of polyvinyl sulfonic-co-vinyl alcohol)-g-poly(lactide-co-glycolide) (P(VS-VA)-g-PLGA) with negatively charged electrolyte properties, their method of preparation and their use. These negatively charged graft copolymers are suitable for effective loading and sustained-release of especially positively charged drugs, proteins and peptides, and drug-loaded particles from these grafted co-polymers are especially useful as parenteral or mucosal drug delivery systems for pharmaceutical applications.

Abstract: Disclosed herein are aptamers that comprise a nucleic acid sequence that has a specific affinity for a target. These aptamers can be used as delivery vehicles to deliver specific agents to particular sites. Alternatively, targeted aptamers can also be used with detection techniques to determine the presence of absence of specific targets in heterogeneous backgrounds.

Abstract: The present invention relates to a pharmaceutical composition for sustained release of a pharmaceutically active compound, the composition comprising a vesicular phospholipid gel. More particularly, the invention relates to a pharmaceutical composition comprising at least one proteinaceous substance as the pharmaceutically active compound in encapsulated form, the at least one proteinaceous substance being a biologically active protein, peptide or polypeptide. Furthermore, the present invention relates to a method for the production of said pharmaceutical composition comprising dual asymmetric centrifugation and to the use of said pharmaceutical composition for immunotherapy and/or for stimulating selective tissue regeneration in the treatment of surgical defects in the course of surgical interventions.