Abstract: A method of treating liver inflammation in an individual caused by excess fat deposition, sometimes called “fatty liver disease”, which may be caused by metabolic syndrome, insulin resistance, or gut microbial dysbiosis, and which may lead to the serious and potentially life-threatening condition of non-alcoholic steatohepatitis (NASH). A composition composed of an all-D amino acid peptide and a pharmaceutically acceptable carrier is prepared and administered to a patient. The D peptide has the general structure: A-B-C-D-E in which A is Ser, Thr, Asn, Glu, Ile. B is Ser, Thr, Asp, Asn, C is Thr, Ser, Asn, Arg, Lys, Trp, D is Tyr, and E is Thr, Ser, Arg, Gly. The composition acts to suppress inflammation underlying steatohepatitis. The D peptide may be esterified, glycosylated, or amidated at E to enhance tissue distribution by promoting egress from the circulation and penetration into the liver.

Abstract: The invention relates to composition comprising a pharmaceutically effective amount of one or more functional vasoactive intestinal peptide (VIP) fragments, and the use of those compositions in the treatment of fibrosis, hypertension and other disorder.

Abstract: The invention relates to compositions comprising vasoactive intestinal peptide (VIP) or fragments thereof, and the use of such compositions in the treatment of kidney disease, in particular kidney fibrosis, and other associated conditions.

Abstract: Formulations are provided that comprise compounds having inter alia good duration of action, high potency and/or convenient dosing regimens, and a permeation enhancer for transmucosal administration. The compounds are engineered polypeptides which incorporate an albumin binding domain in combination with one or more biologically active polypeptides. The pharmaceutical compositions provided are suitable for methods of treatment for diseases and disorders including obesity and overweight, diabetes, dyslipidemia, hyperlipidemia, Alzheimer's disease, fatty liver disease, short bowel syndrome, Parkinson's disease, cardiovascular disease, and other and disorders of the central nervous system.

Abstract: A polypeptide, a nucleic acid molecule encoding the polypeptide and a pharmaceutical composition comprising the polypeptide are provided. The polypeptide is as defined in the description, can bind to insulin receptors, and is effective in reducing blood sugar, reducing glycated hemoglobin, and ameliorating hepato-renal disorders caused by diabetes.

Abstract: This invention relates to novel analogs of pituitary adenylate cyclase-activating polypeptide (PACAP), which are agonists for the PACAP/vasoactive intestinal peptide (VIP) receptors: PAC1, VPAC1 and VPAC2 receptors. These PACAP analogs can be used as prophylactic/therapeutic agents for a wide range of medical disorders, including (but not limited to) cancer and autoimmune disease. These PACAP analogs can be coupled to suitable radionuclides and used in the localization, diagnosis and treatment of disseminated cancers and metastatic tumors, or coupled to small molecule therapeutics and used as vectors for targeted drug delivery. This invention also provides pharmaceutical compositions of one or more PACAP-like compounds of the invention either alone or in combination with one or more other prophylactic/therapeutic agents.

Abstract: The invention generally relates to compositions and methods for the reduction or neutralization of toxins associated with a bacterial, mycobacterial, fungal, viral, or protozoal agent. More particularly, the invention is directed to sterically stabilized phospholipid micellar and liposomal compositions, which interact with the toxins to decrease or neutralize their toxicity. Additionally, the invention includes the use of sterically stabilized phospholipid micellar compositions comprising one or more water-insoluble antibiotic, antifungal, antiviral, antiprotozoal, or anti-inflammatory agent(s), wherein the micellar or liposomal composition inhibits the formation of aggregates. The invention further includes the use of sterically stabilized micelle and liposomal compositions to deliver compounds to the site of action, and in some cases targets the compound to the site of action, for the treatment of inflammation and infection.

Abstract: The invention relates to composition comprising a pharmaceutically effective amount of one or more functional vasoactive intestinal peptide (VIP) fragments, and the use of those compositions in the treatment of fibrosis, hypertension and other disorder.

Abstract: This disclosure relates to a method of generating conditionally active biologic proteins from wild type proteins, in particular therapeutic proteins, which are reversibly or irreversibly inactivated at the wild type normal physiological conditions. For example, evolved proteins are virtually inactive at body temperature, but are active at lower temperatures.

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: Nanoparticles comprising VIP and their use in treating, e.g. pulmonary hypertension. Such nanoparticles provide improved delivery of VIP and allow for acute treatment and optionally for sustained release of VIP in a patient.

Abstract: The present invention relates to ophthalmic preparations in the form of eyedrops based on PACAP (Pituitary Adenylate Cyclase Activating Polypeptide) which restore the normal visual function in retinal dystrophy/retinopathy and optic neuropathy, with special reference to glaucoma. Said preparations can be administered topically to the intact eye surface, and are useful in the treatment of various forms of retinal dystrophy/retinopathy and optic neuropathy, such as glaucoma.

Abstract: Pharmaceutical compositions and methods for treating diseases associated with angiogenesis and inflammation. The invention relates to a pharmaceutical composition that includes a therapeutically effective amount of sCD26 and/or a biologically active derivative thereof and a pharmaceutically acceptable carrier. The composition may further include a therapeutically effective amount of sFlt-1 and/or a biologically active derivative thereof. Additionally, the invention relates to methods for treating a disease associated with and/or progresses by an inflammatory cytokine-associated inflammation and/or VEGF-associated angiogenesis.

Abstract: The present invention provides therapeutic agents and compositions comprising elastic peptides and therapeutic proteins. Such peptides exhibit a flexible, extended conformation. In some embodiments, the therapeutic protein is a GLP-1 receptor agonist (e.g., GLP-1, exendin), insulin, or Factor VII/VIIa, including functional analogs. The present invention further provides encoding polynucleotides, as well as methods of making and using the therapeutic agents. The therapeutic agents have improvements in relation to their use as therapeutics, including, inter alia, one or more of half-life, clearance and/or persistence in the body, solubility, and bioavailability.

Abstract: The invention relates to compositions comprising vasoactive intestinal peptide (VIP) or fragments thereof, and the use of such compositions in the treatment of aortic fibrosis and other associated conditions.

Abstract: The present invention is directed to compositions and methods for inhibiting the development of new lymphatic vessels, and for inhibiting tumor cell dissemination through the lymphatics. In preferred embodiments, the present invention utilizes agents that inhibit the specific binding of integrin alpha4beta1 (?4?1, VLA-4) to one or more of its ligands. The invention further relates to methods for screening test compounds for their ability to inhibit undesirable lymphangiogenesis and/or tumor metastasis.

Abstract: The present disclosure relates to compositions and methods for the diagnosis of schizophrenia. In particular, the instant disclosure is directed to identification of novel copy number variants of sequences associated with the VIPR2 gene, including certain micro-duplications and triplications, and correlation of these copy number variants with schizophrenia.

Abstract: The present invention provides pharmaceutical formulations for sustained release, and methods for delivering a treatment regimen with a combination of sustained release and long half-life formulations. The invention provides improved pharmacokinetics for peptide and small molecule drugs.

Abstract: Controlled release of VIP from PLGA microparticles was accomplished and varied through use of different polymer molecular sizes, addition of solutes to the inner aqueous phase, and use of our computer model. Released VIP from microparticles appeared to be bioactive and caused DCs to produce more CCL22 than DCs treated with blank particles at 7 and 24 hours. Additionally, DCs treated with VIP microparticle releasates recruited higher percentages of FoxP3+ T-cells in in vitro chemotaxis studies. Testing in a mouse model in vivo indicated that VIP microparticles have significant therapeutic potential to treat periodontal disease by reducing the bone loss in infected mice relative to the blank group.

Abstract: The invention relates to compositions comprising vasoactive intestinal peptide (VIP) or fragments thereof, and the use of such compositions in the treatment of aortic fibrosis and other associated conditions.

Abstract: System and methods for isolation of collagen and other fibrous tissue from adipose tissue are described herein. The method of the present invention isolates the collagen from adipose tissue by sonication. The tissue to be sonicated is placed in a container or a flow cell transparent to ultrasound waves. After sonication the sonicated material is filtered out through the bottom of the flow cell and the sonicated collagen is trapped in the filter, which may be taken for further processing. The isolated collagen can then be combined with a suitable carrier for re-injection to correct various tissue defects such as wrinkles, to form a carrier for the stem cells, a filler, and matrix for new collagen production by injecting into the desired area of the host.

Abstract: A polypeptide, a nucleic acid molecule encoding the polypeptide and a pharmaceutical composition comprising the polypeptide are provided. The polypeptide is as defined in the description, can bind to insulin receptors, and is effective in reducing blood sugar, reducing glycated hemoglobin, and ameliorating hepato-renal disorders caused by diabetes.

Abstract: Novel iron chelators exhibiting neuroprotective and good transport properties are useful in iron chelation therapy for treatment of a disease, disorder or condition associated with iron overload and oxidative stress, e.g., a neurodegenerative or cerebrovascular disease or disorder, a neoplastic disease, hemochromatosis, thalassemia, a cardiovascular disease, diabetes, an inflammatory disorder, anthracycline cardiotoxicity, a viral infection, a protozoal infection, a yeast infection, retarding aging, and prevention and/or treatment of skin aging and skin protection against sunlight and/or UV light. The iron chelator function is provided by a 8-hydroxyquinoline, a hydroxypyridinone or a hydroxamate moiety. The neuroprotective function is imparted to the compound, e.g., by a neuroprotective peptide. A combined antiapoptotic and neuroprotective function is provided by a propargyl group.

Abstract: The invention relates to compositions comprising vasoactive intestinal peptide (VIP) or fragments thereof, and the use of such compositions in the treatment of kidney disease, in particular kidney fibrosis, and other associated conditions.

Abstract: The invention describes compositions of peptide analogs that are active in blood or cleavable in blood to release an active peptide. The peptide analogs have a general formula: A-(Cm)x-Peptide (SEQ ID NO: 76), wherein A is hydrophobic moiety or a metal binding moiety, e.g., a chemical group or moiety containing 1) an alkyl group having 6 to 36 carbon units, 2) a nitrilotriacetic acid group, 3) an imidodiacetic acid group, or 4) a moiety of formula (ZyHisw)p (SEQ ID NO: 50), wherein Z is any amino acid residue other than histidine, His is histidine, y is an integer from 0-6; w is an integer from 1-6; and p is an integer from 1-6; wherein if A has alkyl group with 6 to 36 carbon units x is greater than 0; and Cm is a cleavable moiety consisting of glycine or alanine or lysine or arginine or N-Arginine or N-lysine, wherein x is an integer between 0-6 and N may be any amino acid or none. The peptide analogs are complexed with polymeric carrier to provide enhanced half-life.

Abstract: The present invention relates to methods of preventing or reducing the risk of acute and chronic rejection of transplanted organs. The invention relates to the administration of T3, VIP, and T3/VIP nanoparticles to a donor organ in order to prevent or reduce the risk of rejection, e.g. acute or chronic rejection.

Abstract: A formulation comprising T3/VIP nanoparticles, wherein the T3/VIP nanoparticle comprises both T3 and VIP encapsulated or immobilized on a bioabsorbable polymer. The invention further provides for methods of making a formulation comprising a T3/VIP nanoparticle. The invention further provides for methods of treatment utilizing said T3/VIP nanoparticle.

Abstract: The invention relates to compositions comprising vasoactive intestinal peptide (VIP) or fragments thereof, and the use of such compositions in the treatment of kidney disease, in particular kidney fibrosis, and other associated conditions.

Abstract: Hibernating myocardium is characterized by viable myocardium with impaired function due to localized reduced perfusion. Hibernating myocytes retain cellular integrity, but cannot sustain high-energy requirements of contraction. High plasma levels of catecholamines, such as norepinepherine, are believed to be predictive of mortality from hibernating myocardium. Likewise, high levels of catecholamines lead to cardiomyopathy in patients with diabetes. GLP-1 reduces plasma norepinepherine levels, and it thus is useful in a method of treating hibernating myocardium or diabetic cardiomyopathy.

Abstract: Methods and compositions for treating central nervous system diseases and disorders are disclosed.

Abstract: The invention relates to composition comprising a pharmaceutically effective amount of one or more functional vasoactive intestinal peptide (VIP) fragments, and the use of those compositions in the treatment of fibrosis, hypertension and other disorders.

Abstract: This invention relates to novel compositions comprising analogs of naturally occurring polypeptides, wherein the analog comprises an a-amino acid and at least one ?-amino acid. Administration of the compositions may be used for effecting treatment or prevention of a plurality of disease states caused by dysfunctional biochemical or biological pathways. The compositions and methods of this invention are particularly useful to identify novel therapeutic modulators of in-vivo receptor activity with extended half-lives and relevant bioactivity as compared to the naturally translated polypeptides upon which the analogs are derived.

Abstract: A method and device for discharging an electrical defibrillation pulse or an electrical demand pacer pulse or delivering at least one pharmaceutical agent to treat conditions such as cardiac arrest, bradycardia, arrhythmia, cardiac standstill, PEA, EMD and other heart conditions are disclosed. The pharmaceutical agent can be delivered into the heart tissue, the heart cavity, or the peritoneal cavity. The pharmaceutical agent can also include analgesics such as morphine. Also included are pharmaceutical agents used to increase myocardial contractility or inhibit platelet aggregation and vasoactive intestinal polypeptide (VIP) and thyroid hormones such as T3 and T4 can be delivered. A method for the treatment of cardiac arrest or pulmonary hypertension patients by administering a therapeutically effective amount of vasoactive intestinal polypeptide is also encompassed by the invention.

Abstract: Provided herein are methods of enhancing in vivo efficacy of an active agent, comprising: administering to a subject an active agent that is coupled to a bioelastic polymer or elastin-like peptide, wherein the in vivo efficacy of the active agent is enhanced as compared to the same active agent when administered to the subject not coupled to (or not associated with) a bioelastic polymer or ELP.

Abstract: This disclosure relates to a method of generating conditionally active biologic proteins from wild type proteins, in particular therapeutic proteins, which are reversibly or irreversibly inactivated at the wild type normal physiological conditions. For example, evolved proteins are virtually inactive at body temperature, but are active at lower temperatures.

Abstract: Novel iron chelators exhibiting neuroprotective and good transport properties are useful in iron chelation therapy for treatment of a disease, disorder or condition associated with iron overload and oxidative stress, e.g., a neurodegenerative or cerebrovascular disease or disorder, a neoplastic disease, hemochromatosis, thalassemia, a cardiovascular disease, diabetes, an inflammatory disorder, anthracycline cardiotoxicity, a viral infection, a protozoal infection, a yeast infection, retarding aging, and prevention and/or treatment of skin aging and skin protection against sunlight and/or UV light. The iron chelator function is provided by a 8-hydroxyquinoline, a hydroxypyridinone or a hydroxamate moiety. The neuroprotective function is imparted to the compound, e.g., by a neuroprotective peptide. A combined antiapoptotic and neuroprotective function is provided by a propargyl group.

Abstract: The invention relates to compositions comprising vasoactive intestinal peptide (VIP) or fragments thereof, and the use of such compositions in the treatment of aortic fibrosis and other associated conditions.

Abstract: The invention generally relates to compositions and methods for the reduction or neutralization of toxins associated with a bacterial, mycobacterial, fungal, viral, or protozoal agent. More particularly, the invention is directed to sterically stabilized phospholipid micellar and liposomal compositions, which interact with the toxins to decrease or neutralize their toxicity. Additionally, the invention includes the use of sterically stabilized phospholipid micellar compositions comprising one or more water-insoluble antibiotic, antifungal, antiviral, antiprotozoal, or anti-inflammatory agent(s), wherein the micellar or liposomal composition inhibits the formation of aggregates. The invention further includes the use of sterically stabilized micelle and liposomal compositions to deliver compounds to the site of action, and in some cases targets the compound to the site of action, for the treatment of inflammation and infection.

Abstract: The invention relates to compositions comprising vasoactive intestinal peptide (VIP) or fragments thereof, and the use of such compositions in the treatment of kidney disease, in particular kidney fibrosis, and other associated conditions.

Abstract: The invention describes compositions of peptide analogs that are active in blood or cleavable in blood to release an active peptide. The peptide analogs have a general formula: A-(Cm)x-Peptide (SEQ ID NO: 76), wherein A is hydrophobic moiety or a metal binding moiety, e.g., a chemical group or moiety containing 1) an alkyl group having 6 to 36 carbon units, 2) a nitrilotriacetic acid group, 3) an imidodiacetic acid group, or 4) a moiety of formula (ZyHisw)p (SEQ ID NO: 50), wherein Z is any amino acid residue other than histidine, His is histidine, y is an integer from 0-6; w is an integer from 1-6; and p is an integer from 1-6; wherein if A has alkyl group with 6 to 36 carbon units x is greater than 0; and Cm is a cleavable moiety consisting of glycine or alanine or lysine or arginine or N-Arginine or N-lysine, wherein x is an integer between 0-6 and N may be any amino acid or none. The peptide analogs are complexed with polymeric carrier to provide enhanced half-life.

Abstract: The present invention provides modified Vasoactive Intestinal Peptides (VIPs), encoding polynucleotides and vectors, as well as pharmaceutical compositions comprising the same. The invention further provides methods of making and using the modified VIP agents. In accordance with the invention the VIP exhibits an extended circulatory half-life, receptor-binding or biological potency, and/or altered receptor binding profile with respect to unmodified VIP.

Abstract: Provided are methods of treatment of many different diseases and disorders using micelle and sterically stabilized crystalline compounds of the invention.

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: The present invention is concerned with composition and methods for treatment of certain cardiovascular conditions. In particular it is concerned with prophylactic or therapeutic treatment of myocardial fibrosis or associated conditions by administering compositions comprising vasoactive intestinal peptide (VIP) and/or active fragments) thereof.

Abstract: The present invention relates to peptides which are highly biologically and pharmacologically active as therapeutic drug for the treatment of diseases related to sarcoidosis. The peptides which can be used according to the invention for the treatment of said disease comprise at least one specific highly conservative amino acid residue sequence which seem to play an important role in connection with pulmonary and arteriolar hypertension events. It could be shown that the known naturally occurring peptides “vasoactive intestinal peptide (VIP)” and “pituitary adenylate cyclase-activating polypeptide (PACAP)”, having these specific sequences are potent drugs which can be successfully used for treatment of sarcoidosis. Furthermore, the present invention discloses a method for the treatment patients suffering from sarcoidosis.

Abstract: The present invention encompasses peptides that selectively activate the VPAC2 receptor and are useful in the treatment of diabetes.