Abstract: Regression associated antigens (RAAs) are identified in material from neoplastic cells by their immunological reactivity with regression associated antibodies from the serum of patients diagnosed as undergoing regression of a tumor. Regression associated antibodies (RAAbs) are identified by their absence during progression of a neoplastic disease state and by their presence in a diagnosed state of regression. RAAs have been purified and used to monitor the condition of cancer patients. Production of RAAbs and treatments employing those antibodies are described. It is herein disclosed that RAAs are expressed by M. hyorhinis and are also expressed by expression of provided nucleotide sequences in recombinant host cells, particularly nucleotide sequence for 38 kd and 43 kd RAAs as expressed in E. coli. RAAs and nucleic acids encoding RAAs (or portions thereof) and RAAbs may be used in diagnostic assays and immunotherapy.

Abstract: This invention relates to two methods for solubilizing proteins which are rendered insoluble by bacterial expression. One method comprises directly lysing the host bacterial cells with the detergent Sarkosyl. The other method comprises conventional lysing of the bacteria followed by an extraction process using Sarkosyl and fractionation. These methods render the proteins soluble. They do not entail harsh denaturation of the proteins, and therefore do not require renaturation of the proteins in many cases. Rather, they render the proteins soluble, in their native form.

Abstract: The present invention provides novel antigenic preparations comprising proteinaceous material associated with adenylate cyclase activity in cultures of B. pertussis, the said preparations being useful as components of acellular whooping cough vaccines. The invention further provides methods for the isolation of such antigenic preparations.

Abstract: The subject invention concerns novel methods and compositions for thrombolytic therapy. More specifically, a receptor with high affinity for plasmin has been characterized, purified, cloned, and expressed. This receptor can be used in combination therapies where it is administered prior to, concurrently with, or after a plasminogen activator. Also, this receptor can be bound to plasmin and administered to humans or animals in need of fibrinolytic activity. Additionally, the invention pertains to a novel immobilized form of plasmin which advantageously accumulates at the point where antifibrinolytic activity is needed.

Abstract: An acid inhibitor of bacterial origin which is effective in inhibiting acid secretion from gastric parietal cells; a method of producing this acid inhibitor; a method of administering the acid inhibitor to reduce acid secretion by parietal cells; and a therapeutic composition, which includes the acid inhibitor, for use in the method. In particular, the invention relates to a protein produced by gastric Spirilla, such as Helicobacter pylori (H. pylori), which is effective in inhibiting acid secretion by parietal cells and, thus, can be used in the treatment of peptic ulcer disease and other conditions of the gastroduodenal tract in which there is a tendency for ulceration.

Abstract: The following new polypeptides are described: (a) H-X.sup.1 -Asp-Asp-Pro-Pro-Ala-Thr-Val-Tyr-Arg-Tyr-Asp-Ser-Arg-Pro-Pro-Glu-Asp-X.sup .2 -Y, (b) H-X.sup.1 -Ser-Glu-Tyr-Leu-Ala-His-Arg-Arg-Ile-Pro-Pro-Glu-Asn-Ile-Arg-Arg-Val-Thr-A rg-Val-X.sup.2 -Y, (c) H-X.sup.1 -Ala-Phe-Val-Ser-Thr-Ser-Ser-Ser-Arg-Arg-Tyr-Thr-Glu-Val-Tyr-X.sup.2 -Y, (d) H-X.sup.1 -Gly-Ile-Thr-Gly-Glu-Thr-Thr-Thr-Thr-Glu-Tyr-Ser-Asn-Ala-Arg-Tyr-Val-X.sup .2 -Y, and (e) H-X.sup.1 -Leu-Glu-His-Arg-Met-Gln-Glu-Ala-Val-Glu-Ala-Glu-Arg-Ala-Gly-Arg-Gly-Thr-G ly-His-Phe-Ile-X.sup.2 -Y, in which X.sup.1 and X.sup.2 each represents an optional coupling-facilitating amino acid residue, and Y represents --OH or --NH.sub.2. Additionally, there is described an artificial pertussis toxin antigen, which mainly consists of at least one peptide sequence reacting with antibodies induced by the native pertussis toxin selected from the above polypeptides (a) to (e) and parts thereof.

Abstract: Immunogenic components are recovered from pathogenic bacteria grown on semi-defined, serum-free media in purified forms that are useful as veterinary acellular vaccines and include both polysaccharides as well as proteins. Recovery is accomplished by homogenizing the cells; precipitating unwanted cellular compounds such as nucleic acids using a quaternary ammonium salt to form insoluble ionic complexes; treating the resulting supernatant with a hypersaline solution to dissociate any residual ionic complexes; and concentrating and dialyzing the supernatant to remove the ammonium and chloride salts and various unwanted components derived from the culture medium.

Abstract: Novel hG-CSF polypeptide derivatives having an amino acid sequence derived from the amino acid sequence of the human granulocyte colony stimulating factor polypeptide by substitution of at least one amino acid by a different amino acid and/or deletion of at least one amino acid, recombinant plasmids containing a DNA fragment insert coding for any of these hG-CSF polypeptide derivatives, microorganisms carrying one of such plasmids, methods of producing the hG-CSF polypeptide derivatives using the microorganisms, a monoclonal antibody binding to the hG-CSF polypeptide derivative, and chemically modified hG-CSF or derivatives thereof are disclosed.

Abstract: The invention is to a method of treating malignancies with cholera toxin after determining if labelled beta subunit cholera toxin binds to the tissue.

Abstract: Disclosed and claimed are Bacillus thuringiensis isolates designated B.t. PS45B1, B.t. PS24J, B.t. PS94R3 B.t. PS17, B.t. PS62B1 and B.t. PS74G1 which are active against acarid pests. Thus, these isolates, or mutants thereof, can be used to control such pests. Further, genes encoding novel .delta.-endotoxins can be removed from these isolates and transferred to other host microbes, or plants. Expression of the .delta.-endotoxins in microbe hosts results in the control of acarid pests, whereas transformed plants become resistant to acarid pests.

Abstract: The invention relates to a protein stabilizing sequence particularly useful for stabilization of proteolytically sensitive proteins. The sequence includes a relatively small number of amino acids that may be expressed fused with a proteolytically sensitive protein. The most effective stabilization sequences assume .alpha.-helix structures with a hydrophobic face and a positively charged polar face which appear to require proper orientation with respect to each other. Other aspects of the invention include cloning vectors incorporating a gene sequence encoding the stabilization polypeptide and production of stabilized antigenic proteins.

Abstract: The invention relates to a number of synthetic polypeptides which correspond to a part of the sequences of the Shiga B peptide chain. More specifically, the invention relates to polypeptides corresponding to the residues 5 to 18, 7 to 26, 13 to 26, and 19 to 29 of said B chain. The invention further relates to the conjugates of each of these with a suitable carrier and to polymers of each or these obtained by polymerization with a suitable polymerization agent: these can be used as effective vaccines which afford protection against Shiga toxin. Anti-peptide anti-sera are effective in neutralizing to a large extent the biological activity of Shiga toxin.

Abstract: A purified, characterized surface protein from Bacteroides loeschei is an adhesin which is useful in inhibiting plaque formation. The adhesin is also useful in a diagnostic assay for gingivitis, a diagnostic indicator for changes in the surface components of certain human tissues, and as a binding agent to purify polysaccharides.

Abstract: An immunoassay procedure is provided which exhibits increased specificity over current procedures. The procedure allows the differentiation of animals infected with Brucella abortus from animals vaccinated with Brucella abortus Strain 19. The invention employs unique monospecific monoclonal antibodies having particular affinity, specificity and binding characteristics directed to a B. abortus lipopolysaccharide antigen. The invention also concerns continuous hybrid cell lines for producing the unique monoclonal antibodies.

Abstract: Immunostimulant products are prepared by adding lysozyme to a culture of L.bulgaricus at a pH of from 4-8 and then incubating the culture to hydrolyze peptidoglycans of cell walls of the bacteria. A suspension containing the lysozyme-treated L.bulgaricus is collected, which is centrifuged to obtain an immunostimulant supernatant. The supernatant may be filtered to obtain an immunostimulant solution, which may be added to a fermented milk, or to a whey, to prepare an immunostimulant product. Alternatively, L.bulgaricus may be cultured and hydrolyzed by lysozyme in a milk product to provide an immunostimulant milk product.

Abstract: The present invention relates to novel chemically synthesized nucleotides and novel chemically synthesized peptides which have been found to be effective in assaying for the presence of M. tuberculosis.

Abstract: The invention relates to a new signal peptide from Bordetella pertussis with the amino acid sequence M K K W F V A A G I G A G L L M L S S A A and to particularly suitable expression vectors with whose aid such signal sequences can be found and/or evaluated.

Abstract: A method of extracting granulocyte/macrophage colony stimulating factor (GM-CSF) from GM-SCF-expressing bacterial cells comprising treating a suspension of GM-CSF-containing bacterial cells with an acid and an enhancing agent, or with an acid that is itself an enhancing agent, removing substantially all of the suspension liquid from the cells, preparing a second suspension of the acidified cells, neutralizing said second suspension, and separating the GM-CSF-containing liquid from the suspended cells.

Abstract: The present invention relates to (1) an enzyme-linked immunosorbent assay (ELISA) for detection in milk of antibodies of any isotype which are specific for Staphylococcus aureus proteins in molecular weights ranging from 14,000 to 26,000 daltons, (2) a process for production and purification of the proteins, (3) a method of performing the ELISA utilizing the proteins (4) use of the ELISA for detection of intramammary infection by S. aureus, (5) preparation of monoclonal and polyclonal antibodies against the selected fractions, (6) use of such antibodies of purification of infection specfic antigens, and (7) use of the antibodies in an ELISA for antibodies produced in an individual in response to infection by S. aureus.

Abstract: Reagent for analysis of triglycerides contained in blood serum is provided, which comprises lipases and monoglyceride lipases capable of acting on monoglycerides having substrate specificity and capable of catalyzing the following enzymatic reaction: monoglyceride+H.sub.2 O.fwdarw.glycerol+fatty acids. The glycerol or fatty acids are measured to learn an amount of the triglycerides or fatty acid by any known analytical method.

Abstract: A biologically active reference therapeutic protein is protected against oxidation by a method involving substituting a conservative amino acid for each methionyl residue susceptible to chloramine T or peroxide oxidation, wherein additional, non-susceptible methionyl residues are not so substituted. The oxidation-resistant mutein so produced is preferably a human mutein of interleukin-2 or interferon-.beta., and the conservative amino acid is most preferably alanine.

Abstract: A method for obtaining DNA expressing histidine rich protein of various types of Plasmodia is disclosed. The method involves hybridization with the comparable DNA of P. lophurae. The method of particularly well suited for obtaining P. falciparum DNA, whether it is associated with know or knobless phenotype. Additionally, the invention disclosed a safe method for diagnosing P. falciparum infection.

Abstract: PSC-A is a new serological common antigen to Pseudomonas aeruginosa having very low toxicity, and highly effective for protecting infection by any of the serotypes of Pseudomonas aeruginosa. PSC-A can be used as the active component in a pharmaceutical agent for protecting Pseudomonas aeruginosa infection.

Abstract: Peptides and proteins related to an epitope comprising an outer membrane protein of Haemophilus influenzae are described. The peptides and proteins can be prepared by methods including novel and improved methods of puiification from H. influenzae cultures, and by recombinant DNA and chemical synthetic techniques. Additionally, recombinant vectors containing nucleotide sequences encoding PBOMP-1 and PBOMP-2 related peptides and proteins are also described. Recombinant vectors include plasmid DNA and viral DNA such as human viruses, animal viruses, insect viruses and bacteriophages that direct the expression of the PBOMP-1 and PBOMP-2 related peptides and proteins in appropriate host cells. The peptides, proteins and viruses both "live" and "inactivated" are used as immunogens in vaccine formulations to protect against H. influenzae infections. The peptides and proteins are also used as reagents in immunoassays as well as to prepare immunoglobulins for passive immunization.

Abstract: A method for the solubilization and naturation of somatotropin from refractile bodies produced by r-DNA technology wherein the refractile bodies are dissolved in an aqueous solution comprising a chaotropic agent such as urea or guanidine hydrochloride and a soluble organic alcohol such as isopropanol or benzyl alcohol. The solubilized protein is exposed to mild oxidation for a time sufficient to allow the protein to form disulfide bonds and refold to its native conformation. The presence of the alcohol suppresses the formation of somatotropin dimers and aggregates and results in higher yields of the desirable monomeric form of the protein.

Abstract: The subject invention concerns the use of a novel and useful bioinsecticide against the lesser mealworm (Alphitobius diaperinus). The lesser mealworm is a devastating pest in the poultry industry. The bioinsecticide of the subject invention is a novel B. thuringiensis microbe referred to as B.t. PS122D3, or mutants thereof. The spores or toxin crystals of this microbe are useful to control the lesser mealworm in various environments.

Abstract: A novel B.t. toxin gene encoding a protein toxic to coleopteran insects has been cloned from a novel coleopteran-active B. thuringiensis microbe. The DNA encoding the B.t. toxin can be used to transform various prokaryotic and eukaryotic microbes to express the B.t. toxin. These recombinant microbes can be used to control coleopteran insects in various environments.

Abstract: Recombinant hepatitis B virus surface proteins produced in recombinant host cells are rapidly and efficiently purified from either cell extracts in a high pH buffer, or from heated whole cells at neutral pH. The host cell extracts or whole cells are heat treated, cooled and in the case of high pH extract, the pH is reduced. The surface proteins are then absorbed onto wide pore silica followed by elution and concentration. This method eliminates the requisite introduction of protease inhibitors, stabilizes the surface protein and improves product yield.

Abstract: The gene encoding the TcpA pilus has been cloned. It encodes a protein useful in live, killed-cell, and synthetic vaccines. Protein production is enhanced by specific medium conditions.

Abstract: Peptides and proteins related to an epitope comprising an outer membrane protein of Haemophilus influenzae are described. The peptides and proteins can be prepared by methods including novel and improved methods of purification from H. influenzae cultures, and by recombinant DNA and chemical synthetic techniques. Additionally, recombinant vectors containing nucleotide sequences encoding PBOMP-1 and PBOMP-2 related peptides, proteins and fusion proteins are also described. Recombinant vectors include plasmid DNA and viral DNA such as human viruses, animal viruses, insect viruses and bacteriophages that direct the expression of the PBOMP-1 and PBOMP-2 related peptides, proteins, and fusion proteins in appropriate host cells. The peptides, proteins, fusion proteins and viruses both "live" and "inactivated" are used as immunogens in vaccine formulations to protect against H. influenzae infections.

Abstract: The subject invention concerns a novel in vitro process for identifying and quantifying native antigens on potentially pathogenic group B streptococci bacteria present in a clinical specimen. The invention process is made possible by the discovery of novel bacterial markers denoted .gamma. and .delta. epitopes which are expressed by a variety of group B streptococcal strains.

Abstract: A dermatological hair growth stimulating composition containing an effective amount of a glycoprotein extract of gram negative bacteria as the growth stimulant and a method of stimulating hair growth.

Abstract: The subject invention concerns novel protein A or protein A-like molecules that can be coupled to other materials through a single, defined site on the protein A molecule. Specifically exemplified is Cysteinyl-rProtein A.TM.. The compounds of the invention, for example, Cysteinyl-rProtein A.TM., can be used in processes wherein protein A is used.

Abstract: The present invention provides a chimeric protein IL4-PE40 which selectively kills IL4 receptor bearing cells. A mutant form of the protein is also provided.

Abstract: The invention relates to a process for the preparation of purple membrane containing bacteriorhodopsin, which process comprises obtaining, in a manner know per se, the cell membrane from halobacteria cells, and subjecting the material to gel filtration chromatography in order to isolate the purple membrane from the cell membrane.

Abstract: A type II, proteinaceous, antigenic factor derived from a Group A streptococci which is a receptor for the Fc region of human Ig G3 and which exhibits a major diffuse protein band on polyacrylamide gel electrophoresis and which has a molecular weight of about 38,000 daltons.

Abstract: The present invention relates to an in vitro method for measuring the toxicity of a delta-endotoxin of Bacillus thuringiensis by evaluating the ability of said endotoxin to form an ion channel in a phospholipid vesicle.

Abstract: The invention provides a novel antibiotic or antibiotic fraction and a process for producing it by culturing a suitable microorganism. Among other defined properties, the antibiotic has a protein and lipid content, a molecular weight of about 63,500 daltons and antibiotic activity against fungi and gram-positive bacteria, but not against gram-negative bacteria. It is useful for plant protection.

Abstract: Novel monoclonal antibodies are disclosed, the production of which is specified by particular genes contained, conveniently, in biologically pure cultures of self-reproducing carrier cells, such as, but not limited to, ATCC HB 8297 and ATCC HB 8298, such antibodies being reactive with at least part of endotoxin core of Gram-negative bacteria. Processes of prepaU.S. GOVERNMENT RIGHTSThe invention described herein may be manufactured, used and licensed by or for the U.S. Government for governmental purposes only without the payment to the inventors of any royalties thereon.

Abstract: A chromatography material comprises a solid support on which is fixed, as a ligan, desialyled gycolprotein selected from desialyled fetuin and desialyled haptoglobin. This material is used to purify protein antigens of bacteria of the Bordetella genus.

Abstract: A modified pertussis toxin suitable as a pertussis vaccine having an essentially unmodified B-oligomer and a catalytic subunit which is inactivated by treatment with polyphosphate compounds, sulfhydryl reductants and mild detergents followed by modification of the activated --SH groups to inhibit ADP-ribosylating activity.

Abstract: A purified antigenic protein has been obtained which is capable of inducing in a chicken an immune response conferring protection against infection by Eimeria necatrix or Eimeria tenella. The protein has a molecular weight of about 26,000 and is composed of two polypeptides joined by a disulfide bond. The two polypeptide subunits have molecular weights of about 18,000 and about 8,000, respectively. The gene encoding the protein has been sequenced and the amino acid sequence of the protein deduced therefrom.The protein and antigenic polypeptides having an amino acid sequence included within the protein may be incorporated into a vaccine for conferring upon a chicken active immunity against infection by E. necatrix or E. tenella.

Abstract: A process is provided for the purification of a proteinaceous physiologically active substance having antitumor activity, which is induced by administering to a rabbit at least one substance having a capacity for stimulating reticuloendothelial system and then injecting endotroxin from a Gram-negative bacterium into the rabbit. The process comprises contacting a crude solution of said proteinaceous physiologically active substance with a basic anion exchanger to have said physiologically active substance adsorbed on the anion exchanger, eluting the adsorbed physiologically active substance, and subjecting the eluate containing said physiologically active substance to gel filtration with a gel suitable for separation of a substance with a molecular weight in the range of 30,000 to 70,000. The purified preparation of said physiologically active substance thus obtained may be used as an antitumore agent for the treatment of malignant tumors.

Abstract: A method for the solubilization and naturation of somatotropin from refractile bodies produced by r-DNA technology wherein the refractile bodies are dissolved in an aqueous solution comprising a chaotropic agent such as urea or guanidine hydrochloride and a soluble surfactant such as sodium dodecylsulfate. The solubilized protein is exposed to mild oxidation for a time sufficient to allow the protein to form disulfide bonds and refold to its native conformation. The presence of the surfactant suppresses the formation of somatotropin dimers and aggregates and results in higher yields of the desirable monomeric form of the protein.

Abstract: A method is disclosed for discriminating between cattle vaccinated against and those infected with Brucella spp. The method involves immunoassay using a purified polysaccharide containing 4,6-dideoxy-4-acylamido-D-mannopyranosyl units obtained from B. abortus or from cross-reacting organisms, and results in improved differentiation between vaccinated and infected animals. Test kits are also disclosed for performing the assay and a process is disclosed for obtaining the O-chain polysaccharides in high purity and yield.

Abstract: A method is provided for recovering a purified animal growth hormone or a polypeptide analog thereof having substantially the same amino acid sequence as, and the biological activity of, the corresponding naturally-occurring animal growth hormone from a bacterial cell in which the animal growth hormone or polypeptide analog has been produced by means of expression of a plasmid encoding the hormone or polypeptide analog which comprises: (a) disrupting the cell wall of the bacterial cell in a buffered neutral pH solution so as to produce a lysate containing precipitated hormone or polypeptide analog; (b) recovering the resulting precipitated hormone or polypeptide analog; (c) suspending the precipitated hormone or polypeptide analog so recovered in distilled water; (d) treating the resulting precipitate-containing suspension with a sodium hydroxide solution having an alkaline pH of about 11.

Abstract: Disclosed is a method for preparing pertussis toxin toxoid by a treatment pertussis toxin with formaldehyde, which comprises carrying out said treatment in the presence of lysine or glycine in combination with N-acetyltriptophan. The resultant toxoid does not exhibit toxicity reversion, thereby making the toxoid highly suitable for use in pertussis vaccines.

Abstract: The present invention relates to the detection of B. gingivalis by the specific ability of B. gingivalis to hydrolyze N-carbobenzoxy-glycyl-glycyl-L-arginine-B-napthylamide derivatives. The present invention also relates to the use of assay systems which inhibit serum amino peptidase and enhance the detection of the B. gingivalis N-CBz-Gly-Gly-Arg peptidase. The assay system inhibits the serum enzyme by the use of a serum aminopeptidase inhibitor which inhibits the activity of serum aminopeptidase to a greater extent that it inhibits the activity of B. gingivalis N-CBz-Gly-Gly-Arg peptidase. The assay system also increases the reliability of detection of the B. gingivalis enzyme by the use of enhancing materials which enhance the enzyme activity of B. gingivalis N-CBz-Gly-Gly-Arg peptidase to a greater extent than such materials enhance the enzyme activity of serum aminopeptidase.

Abstract: Novel Fc receptors, denoted type VI, are disclosed as reacting with rat immunoglobulins with a reasonable affinity. The type VI receptors are isolated from Streptococcus zooepidemicus strain s212 (ATCC 53698) and Streptococcus zooepidemicus strain RSS-212 (ATCC 53697) culture supernatants. These receptors, or the microorganisms which produce them, are useful in immunoassays.

Abstract: An antigen for the detection of Campylobacter pylori infections and an assay for the serological detection of Campylobacter pylori. The antigen includes high molecular weight cell-associated proteins purified from Campylobacter pylori. The antigen can be used in a variety of assays including radioimmunoassay, ELISA, latex agglutination, complement fixation, and indirect hemagglutination. Furthermore, the antigens can be combined with a solid support in kit form.