Abstract: The present invention relates to the purification of the human chorionic gonadotropin .beta.-core molecule which can then be used as the antigen in the preparation of antibodies to the .beta.-core molecule. The combination of the purified .beta.-core molecule and the antibodies can be used in an immunoassay kit to measure .beta.-core molecules in the presence of structurally similar molecules, i.e., hCG, LH, hCG.beta.-subunit and LH.beta.-subunit. Measurement of the .beta.-core molecule is particularly useful in testing for pregnancy and many malignancies.

Abstract: Purified mammalian erythropoietin binding-protein is disclosed, and its isolation, identification, characterization, purification, and immunoassay are described. The erythropoietin binding protein can be used for regulation of erythropoiesis by regulating levels and half-life of erythropoietin. A diagnostic kit for determination of level of erythropoietin binding protein is also described.

Abstract: The present invention relates generally to the fields of immunology and molecular biology, and particularly to a thymus-derived factor which stimulates, enhances or regulates cell-mediated immune responsiveness. In one embodiment, the factor is a substantially homogeneous immune potentiator which stimulates mature T lymphocytes and thus enhances the response of animals, especially mammalian organisms, to infectious agents and to malignancies.

Abstract: DNA encoding modified, secretable erythropoietin proteins whose ability to regulate the growth and differentiation of red blood cell progenitors are different from the wildtype recombinant erythropoietin and to methods of modifying or altering the regulating activity of a secretable erythropoietin and using modified secretable erythropoietin proteins.

Abstract: Extended forms of beta subunits of human glycoproteins wherein the amino acid sequence of a carboxy terminal peptide (CTP) representing positions from about 112-118 to 145 of the human CG-beta subunit or a variant form thereof is appended to the C-terminus are disclosed. Recombinant materials for the production of these extended human glycoprotein beta subunits and production of the modified hormones containing the extended beta subunits are also described. Pharmaceutical compositions containing the modified forms of these hormones are useful in pharmacological applications analogous to those of the unmodified forms.

Abstract: Modified polypeptides with increased biological activity exhibited as either increased potency or prolonged circulating half-life are disclosed with methods of preparing the modified polypeptides and methods of use.

Abstract: Zona pellucida is useful for growth stimulation in animals and especially in female ruminants such as heifers. Immunization of heifers with Zona pellucida obtained from young pig ovaries leads to increased weight gains that are comparable to, or exceed the weight gain achieved with by other growth stimulants given to cattle, such as steroids, antibiotics or ionophores. Zona pellucida treatment results in longer-lasting weight gain response than that achieved with conventional growth stimulants and results in less frequent cattle handling and decreased production costs.

Abstract: Disclosed are novel polypeptides possessing part or all of the primary structural conformation and one or more of the biological properties of mammalian erythropoietin ("EPO") which are characterized in preferred forms by being the product of procaryotic or eucaryotic host expression of an exogenous DNA sequence. Illustratively, genomic DNA, cDNA and manufactured DNA sequences coding for part or all of the sequence of amino acid residues of EPO or for analogs thereof are incorporated into autonomously replicating plasmid or viral vectors employed to transform or transfect suitable procaryotic or eucaryotic host cells such as bacteria, yeast or vertebrate cells in culture. Upon isolation from culture media or cellular lysates or fragments, products of expression of the DNA sequences display, e.g., the immunological properties and in vitro and in vivo biological activities of EPO of human or monkey species origins.

Abstract: A method for increasing the hematocrit of a normal mammal using erythropoietin (EPO) is provided. The method comprises the steps of administering to the mammal a hematocrit increasing effective amount of EPO, in a pharmaceutically acceptable form. Additionally administered is an effective amount of iron, in a pharmaceutically acceptable form, sufficient to increase the serum iron content of the mammal to an erythropoiesis supportable level. The method is useful for increasing the amount of blood that can be donated for transfusion purposes, in particular autologous transfusion.

Abstract: Bactericidal/permeability-increasing protein (BPI) is useful to neutralize non-lipopolysaccharide compounds capable of stimulating TNF production and has application in vitro and in vivo for therapeutics and prophylactic treatment. This use of BPI can be combined with the administration of materials, such as an enzyme, microorganism, living cells or cell fractions, encapsulated in alginate gels.

Abstract: The present invention pertains to an alpha, beta-heterodimeric polypeptide having binding affinity to vertebrate luteinizing hormone (LH) receptors and vertebrate follicle stimulating hormone (FSH) receptors comprising a glycoprotein hormone alpha-subunit polypeptide and a non-naturally occurring beta-subunit polypeptide, wherein the beta-subunit polypeptide is a chain of amino acids comprising the following four joined subsequences:(a) a first subsequence homologous to the amino acid sequence of residues 1-93 of the beta-subunit selected from the group consisting of human chorionic gonadotrophin (hCG), vertebrate luteinizing hormone (LH), vertebrate follicle stimulating hormone (FSH), and vertebrate thyroid stimulating hormone (TSH);(b) a second subsequence homo logous to the amino acid sequence of residues 94-97 of the beta-subunit selected from the group consisting of human chorionic gonadotrophin (hCG) and vertebrate luteinizing hormone (LH);(c) a third subsequence homologous to the amino acid sequence of

Abstract: The present invention concerns a process for the production of well-tolerated, preserved injection or infusion solutions containing human protein.

Abstract: Human urine trypsin inhibitor is provided as an agent for treating acquired immunodeficiency syndrome (AIDS), preventing the infection with AIDS or preventing the onset of AIDS after such infection. It can be administered intravenously for the treatment and externally for the prevention.

Abstract: The subject of the present invention is a peptide structure comprising at leastthe sequence 106-116 of a .beta.-CG or a .beta.-LHa sequence of at least 5 amino acids containing at least one lysine residue.These structures may be used for the preparation of vaccines intended to control fertility.

Abstract: There is provided a method for treating tumors in mammals by the administration of alpha 1-antitrypsin alone or in combination with other protease inhibitors.

Abstract: Polypeptides exhibiting an inhibitory action over follitropin are disclosed. These polypeptides are designated follitropin suppressing proteins, or "FSP's," and range in size from 30 to 60 kD as determined by SDS-PAGE. Uses for FSP's, including regulation of fertility and as immunogens, are disclosed.

Abstract: A purified proteinaceous substance bindable with p185, the translation product of the neu oncogene is disclosed. The purified proteinaceous substance may be characterized in that it increases the activity of the tyrosine kinase contained in the neu oncogene product but does not increase the activity of tyrosine kinase of epidermal growth factor receptor; induces p185 dimerization and internalization; affects the growth of cells which express p185 in a dose dependent manner; is heat stable from about 56.degree. C. to about 100.degree. C.; is degradable by protease; and has a molecular weight of from about 7,000 to about 14,000 daltons in its smallest active form as determined by gel filtration and ultrafiltration membrane analysis. Methods of detecting p185 on the surfaces of tumor cells are also disclosed.

Abstract: A biochemically pure polypeptide(s), termed osteogenic growth polypeptide (OGP), which exhibits stimulatory effects on osteoblastic cells, in vivo bone formation and hemopoietic reconstruction. OGP, identified from regenerating bone marrow, has an amino acid sequence ofAla-Leu-Lys-Arg-Gln-Gly-Arg-Thr-Leu-Tyr-Gly-Phe-Gly-Gly.

Abstract: The invention pertains to pure, native dystrophin of mammalian skeletal muscle and a method of purifying dystrophin from mammalian skeletal muscle. The invention further pertains to a method of diagnosing muscular dystrophy by detecting the loss or abnormal structure of pure, native dystrophin from mammalian skeletal muscle. The detection of a loss of dystrophin or an abnormal structure of dystrophin is indicative of muscular dystrophy.

Abstract: The present disclosure relates to the application of genetic engineering to provide artificial .beta. cells, i.e. cells which can secrete insulin in response to glucose. This is achieved preferably through the introduction of one or more genes selected from the insulin gene, glucokinase gene, and glucose transporter gene, so as to provide an engineered cell having all three of these genes in a biologically functional and responsive configuration. Assays for detecting the presence of diabetes-associated antibodies in biological samples using these and other engineered cells expressing diabetes-associated epitopes are described. Also disclosed are methods for the large-scale production of insulin by perfusing artificial .beta. cells, grown in liquid culture, with glucose-containing buffers.

Abstract: Activin is administered systemically and locally to induce the growth of mature bone. Activin enhances the level of bone formation and the quality of the bone formed when administered locally with BMP or bone marrow. Administration of activin by subcutaneous route promotes systemic increase in the bone mass.

Abstract: A method of purifying granulocyte-macrophage colony-stimulating factor (GM-CSF), particularly recombinant human GM-CSF, in good yield and with retention of biological activity, comprising sequential anion-exchange, dye-ligand affinity, gel filtration and reversed-phase chromatography is disclosed.

Abstract: A composition is disclosed comprising a pharmaceutically acceptable admixture of an osteogenic protein; a porous particulate polymer matrix; an osteogenic protein-sequestering amount of blood clot; and a calcium sulfate hemihydrate-containing substance. Also disclosed are formulations of bone morphogenetic proteins with improved solubility and/or stability characteristics.

Abstract: Herein described are variants of parathyroid hormone that retain significant PTH activity and are substantially resistant to trypsin and trypsin-like enzymes. The variants are useful pharmaceutically, to treat bone disorders such as osteoporosis and in other therapeutic applications. Specific embodiments of the invention include [His.sup.25 ]PTH and [His.sup.25 His.sup.26 Leu.sup.27 ]PTH.

Abstract: The present invention relates to a new pharmaceutical composition for parenteral and local administration comprising an aqueous solution of erythropoietin and a .beta.- or .gamma.-cyclodextrin hydroxyalkyl derivative. The invention also relates to novel lyophilized or spray-dried erythropoietin compositions comprising a .beta.- or .gamma.-cyclodextrin hydroxyalkyl derivative, to processes for preparing such aqueous, lyophilized or spray-dried compositions and to a method for simultaneously stabilizing erythropoietin in an aqueous solution and preventing it from being adsorbed to surfaces.

Abstract: The invention provides .alpha.-1-antichymotrypsin and protein preparations comprising human .alpha.-1-antichymotrypsin produced by E. coli cells transformed with a DNA sequence encoding human .alpha.-1-antichymotrypsin. The invention also provides methods for producing .alpha.-1-antichymotrypsin. The invention further provides analogues of .alpha.-1-antichymotrypsin that exhibit antichymotrypsin, anti-trypsin and anti-thrombin activity and methods of producing the analogues.

Abstract: A protein which satisfies all the biological criteria which are characteristic of inhibin has been isolated from a gonadal source. The purification and characterization of inhibin and the use of the purified material to raise antibodies, the use of inhibin and said antisera in a quantative radioimmunoassay, and application in vitro and in vivo of inhibin and antibody to inhibin, are described. There is provided a purified protein, inhibin characterized in that the apparent molecular weight as determined by SDS-PAGE is 56,000.+-.1,000, the isoelectric point is in the range 6.9-7.3, and the protein can bind specifically to Concanavalin A-Sepharose. Moreover, the protein includes two subunits, characterized in that their apparent molecular weights as determined by SDS-PAGE are 44,000.+-.3,000 and 14,000.+-.2,000, respectively. Furthermore, the isoelectric point of the 44,000 molecular weight sub-unit is in the range of 6.0-7.0. In addition, the N-terminal amino acid sequence of the two subunits are described.

Abstract: Disclosed are (1) a mutein of a fibroblast growth factor (FGF), the DNA having introduced therein at least one nucleotide sequence coding for a glycosylation site, (2) a DNA coding for the mutein of (1), (3) a vector containing the DNA of (2), (4) a transformant transformed with the vector of (3), and (5) a process for producing the mutein which comprises cultivating in a culture medium the transformant of a yeast or animal cell transformed with a vector of (3), and producing and accumulating the mutein of (1) in the culture medium, whereby the FGF mutein into which at least one glycosylation site has been introduced is improved in productivity, stability and activities, and advantageously used as medicine.

Abstract: Disclosed herein are methods and means of producing novel growth hormone-like proteins derived from the pituitary gland of fishes belonging to the order Pleuronectina, the family Paralichthydae, which are useful in the growth promotion for fishes, by genetic engineering using cloned genes.

Abstract: Medicinal compositions containing fibroblast growth factor are stabilized against loss of biological activity by including in said composition a stabilizing amount of phytic add, phosvitin, phosphate buffer, (NH.sub.4).sub.6 P.sub.4 O.sub.13, Na.sub.5 P.sub.3 O.sub.10, Na.sub.4 P.sub.2 O.sub.7 and Na.sub.3 P.sub.3 O.sub.9, adenosine tetra, tri, di and mono phosphate and related diadenosine compounds plus other single and multi-phosphorylated mono and di-nucleotides, poly-aspartic acid, poly-adenylic-guanylic add and related compounds, double stranded deoxyribonucleic add, single stranded deoxyfibonucleic acid and poly-glutamic acid. Medicinal compositions for topical use are combined with a viscous excipient such as a water soluble polysaccharide with said combination with a second stabilizier.

Abstract: A method for purifying erythropoietin is described. The method comprises treating partially purifying erythropoietin by reverse phase high performance liquid chromatography to obtain homogeneous erythropoietin having a molecular weight of about 34,000 daltons on SDS PAGE and moving a single peak on reverse phase HPLC. The homogeneous erythropoietin protein preferably has a specific activity of at least 120,000 IU, more preferably at least 160,000 IU per absorbance unit at 280 nm.

Abstract: The present invention relates to a method and associated agents for measuring the presence and amount of advanced glycosylation endproducts in cells and fluids. The methods take advantage of the existence of receptors and receptor complexes for AGEs and include receptor-containing ligands comprising whole mesangial and other cells, mesangial cellular fragments and protein extracts therefrom. Competitive assays, sandwich assays and assays involving AGE antisera are disclosed. Numerous diagnostic applications are defined and test kits are also contemplated.

Abstract: The present invention discloses a method of purifying Mullerian Inhibiting Substance. The method takes advantage of immunoaffinity chromatography to achieve MIS at up to 95% purity. The method provides for a purified MIS product in which contaminating enzymes having MIS proteolytic activity or inhibitors of MIS antiproliferative activity are substantially removed by addition of an alkali metal halide solution or an alkaline earth metal halide solution prior to elution with an acid solution having a pH of between about 2.5 and 4.0.

Abstract: The present invention relates to a compound which when administered to Leydig cells in the testes stimulates the production of androgen such as testosterone. This compound, when mixed with other known compounds, can produce testosterone levels in excess of those obtained by the administration of a maximal stimulatory dose of Lutenizing Hormone (LH).

Abstract: Denatured recombinant fusion proteins are correctly folded in the presence of a heat shock protein which acts according to the functional principle of the bacterial GroEL or of the equivalent mitochondrial component Hsp60, and of ATP. After cleaving off the foreign sequence, biologically and medically interesting proteins are obtained in the correct conformation.

Abstract: This invention relates to a novel anticoagulant substance in human urine, a process for its preparation and a pharmaceutical composition comprising the said substance for the prevention and/or treatment of diseases related to the disorders in blood coagulation system.

Abstract: Novel polypeptides having a .beta.-adrenergic receptor activity containing the sequence of 402 amino acids, or a fragment of this sequence, said fragment being such that, in particular, either it nonetheless includes the sites contained in said sequence and whose presence is necessary so that, when the fragment is exposed to the surface of a cell, it is capable of participating in the activation of the cyclase adenylate in the presence of an agonist, or it is likely to be recognized by antibodies which also recognize the above succession of 402 amino acids, but fail to recognize the .beta.1 adrenergic receptor and the .beta.2 adrenergic receptor. These polypeptides are useful for screening drugs which act on said polypeptides and for treating obesity, fat diabetes and hyperlipidemias.

Abstract: New biologically active drug polymer derivatives, namely peptides or protein derivatives, are useful medicaments and are represented by the generic formula:RO--(CH.sub.2 --CH.sub.2 O).sub.n --(CO)--NH--X--(CO)--NH--Z (I)whereinR represents a lower alkyl group,n is an integer comprised between 25 and 250,X when combined with adjacent NH and CO groups represents an amino acid or a dipeptide or tripeptide residue, andZ when combined with the adjacent NH group represents a biologically active peptide or protein or NH or NH.sub.2 containing drug residue.

Abstract: Granulocyte-colony stimulating factor (G-CSF) can be delivered systemically in therapeutically or prophylactically effective amounts by pulmonary administration using a variety of pulmonary delivery devices, including nebulizers, metered dose inhalers and powder inhalers. Aerosol administration in accordance with this invention results in significant elevation of the neutrophil levels that compares favorably with delivery by subcutaneous injection. G-CSF can be administered in this manner to medically treat neutropenia, as well as to combat or prevent infections.

Abstract: A protein conjugate or mixture useful in immunotherapy composed of a biological response modifier (BRM) and an allergen is disclosed. In use the protein conjugate or mixture is combined with a pharmaceutically acceptable carrier. Cytokines, bacterial, fungal and viral immunopotentiators and thymus hormones are disclosed as suitable BRM's for use in the invention.

Abstract: The invention proposes a process for purifying a highly glycosylated protein from a crude preparation which comprises the action (i) of adding to said preparation a divalent metal ion in a sufficient amount in order to form a mixture which precipitates and (ii) after precipitation, of harvesting said protein from the mixture supernatant.

Abstract: Described are new glycoprotein hormones capable of competing with natural hormones for the normal receptor binding sites but substantially incapable of effecting post receptor activities. The glycoprotein hormones of the present invention have had specific (rather than all) oligosaccharide chains removed so as to effectively diminish biologic activity while not significantly reducing plasma half-life, thus improving the molecules effectiveness as an antagonist compared with conventionally-produced molecules. The preferred glycoprotein hormones are ideally obtained by site-directed mutagenesis to selectively deglycosylate the protein. Also described are therapeutic treatments comprising the administration of the recombinant glycoprotein hormones of the present invention as hormone antagonists.

Abstract: Method of using uteroferrin and rose for stimulating proliferation of hematopoietic cells.

Abstract: A process for the preparation of stabilized glycoproteins without the introduction of foreign molecules. Susceptible monosaccharides covalently attached to the protein part of the molecule undergo periodate oxidation and, after elimination of the remaining periodate, the oxidized glycoprotein is incubated in a buffer under conditions favorable for the reaction between the aldehyde groups generated in the sugar part and the amino acid residues from the protein part. The oxidized carbohydrate chains act as a polyaldehyde crosslinker, with the cross-linking reaction producing intramolecularly and intermolecularly linked derivatives. The amount and size of the intermolecularly linked derivatives are controlled by degree of oxidation and protein concentration. The thermal stability, depends on the degree of oxidation and under optimal conditions is about 10 times better than the stability of native invertase.

Abstract: A method of imaging a corporeal situs by radiological techniques, comprising delivery to the corporeal situs of an imagingly effectively amount of a physiologically acceptable composition comprising a boron reagent. A variety of illustrative boron reagents is described, including iodinated boron salts, and boron-containing cyclophosphazene and polyphosphazene reagents having radiopaque character. The reagents and method of the present invention may be employed for a wide variety of radiological imaging applications, e.g., excretory urography, angiocardiography, and aortography.

Abstract: A stabilized aqueous antibody composition comprising dextran as a stabilizer in an amount sufficient to prevent deactivation of the monoclonal antibodies at a temperature in the range of 4.degree. to 40.degree. C.

Abstract: Lactoferrin hydrolyzates, having a decomposition rate between 6%-20% as measured by formol titration, for use as an antibacterial agent and which have remarkly more potent activity than unhydrolyzed lactoferrin; and lactoferrin hydrolyzates, having a decomposition rate between 4-50% as measured by formol titration, for use as a tyrosinase inhibition agent, are obtainable by conventional methods for hydrolysis with acids or enzymes, and are stable to heating.

Abstract: Activin is administered systemically and locally to induce the growth of mature bone. Activin enhances the level of bone formation and the quality of the bone formed when administered locally with BMP or bone marrow. Administration of activin by subcutaneous route promotes systemic increase in the bone mass.

Abstract: The present invention relates generally to a T cell growth factor. More particularly, the present invention relates to a T cell growth factor which comprises a glycoprotein which supports interleukin 2- and interleukin 4-independent growth of helper T cells. Even more particularly, the present invention relates to the helper T cell growth factor P40, pharmaceutical compositions thereof and antibodies thereto. The present invention also contemplates a method for inducing the proliferation of helper T cells. The helper T cell growth factor contemplated herein is useful in the stimulation of specific cells in the immune system.

Abstract: The present invention relates to a method and associated agents for measuring the presence and amount of advanced glycosylation endproducts in cells and fluids. The methods take advantage of the existence of receptors and receptor complexes for AGEs and include receptor-containing ligands comprising whole mesangial and other cells, mesangial cellular fragments and protein extracts therefrom. Competitive assays, sandwich assays and assays involving AGE antisera are disclosed. Numerous diagnostic applications are defined and test kits are also contemplated.