Abstract: Compositions comprising a tissue vaccine that include a mixture of heterogeneous tissue obtained from tumors and connective tissues. Vaccines comprising these compositions are also provided, as well as methods of using the vaccines in the treatment and/or inhibition of tumor growth, and particularly prostate tumor growth and cancers. The preparations may be defined as vaccines comprising tumor cells and connective (stromal) tissues derived from xenogeneic animals. Preparations comprising the tissue vaccines are provided using tissue harvested directly from tumors. Methods for preventing de novo development of cancer are also disclosed. A tissue vaccine comprising glutaraldehyde-(GFT) treated tissue prepared from tumor and connective tissue reduces the incidence of autochthonous prostate cancer. A tissue vaccine comprising a potassium thiocyanate extract (PTE) preparation of a tumor and connective tissue is also provided.

Abstract: Disclosed is a multi-compartment medical device useful in the storage, processing and extended shelf life of perishable products, especially pharmaceutical, food and biological products. Particular biological materials processed according to the present methods are human blood and blood products (RBCs). Also disclosed are processes for preserving food, pharmaceutical and biological products for long-term storage and extended shelf life employing a process that reduces the hydration level of the material to less than native hydration levels of the specific product. The invention further provides stabilized biological products, such as in the form of glassified beads, prepared using a two-phase system according to the described processes that may be rehydrated and prepared for clinical use, and having essentially no loss of biological and/or pharmacological activity.

Abstract: Disclosed here are effervescent granules having a controllable rate of effervescence. In some embodiments, the such granules comprise an acidic agent, an alkaline agent, a pharmacologically active agent, hot-melt extrudable binder capable of forming a eutectic mixture with the acidic agent and, optionally, a plasticizer. The effervescent granules are made by a hot-melt extrusion process. The present invention also provides a thermal heat process for preparing a pharmacologically active agent containing effervescent granule. In certain aspects, the granules contain pharmacologically active agents such as narcotics, antidiarrheal agents, antiviral agents, anxiolytic agents, a cholesterol lowering agent, an alpha adrenergic blocking agent, a phenanthrene derivative. By way of example, some of the narcotics that may be included in the granules and in the process of preparing the granules include, by way of example: phenanthrene derivatives (e.g., morphine sulfate), and morphine derivatives (e.g.

Abstract: Disclosed here are effervescent granules having a controllable rate of effervescence. In some embodiments, the such granules comprise an acidic agent, an alkaline agent, a pharmacologically active agent, hot-melt extrudable binder capable of forming a eutectic mixture with the acidic agent and, optionally, a plasticizer. The effervescent granules are made by a hot-melt extrusion process. The present invention also provides a thermal heat process for preparing a pharmacologically active agent containing effervescent granule. In certain aspects, the granules contain pharmacologically active agents such as narcotics, antidiarrheal agents, antiviral agents, anxiolytic agents, a cholesterol lowering agent, an alpha adrenergic blocking agent, a phenanthrene derivative. By way of example, some of the narcotics that may be included in the granules and in the process of preparing the granules include, by way of example: phenanthrene derivatives (e.g., morphine sulfate), and morphine derivatives (e.g.

Abstract: The present invention concerns a formulation of vitamins, minerals and other beneficial supplements which has been demonstrated to be cancer-protective. It is believed that the formulations of the present invention will also protect against cardiovascular disorders, extend longevity as well as to facilitate immunological integrity in humans. More specifically, the invention is directed to a formulation and methods of manufacturing and administering a formulation containing vitamins and minerals in association with antioxidants, fish oils, enzymes, and amino acids. The formulations of the present invention provide synergistic relationships which have not previously been reported. As a preferred embodiment, the formulations of the present invention are manufactured as a sustained-release tableted dietary supplement and are intended as daily supplements.

Abstract: Transdominant HIV tat substitution and truncated gene mutants of 72 amino acid residues or less are disclosed. The mutated genes encode mutant Tat proteins which are capable of inhibiting the expression of the HIV-1 virus in the presence of an equimolar concentration of the wild type Tat protein in vitro. Therapeutic agents which include fused protein forms of the mutant proteins are also disclosed, as well as methods of preparing and using the therapeutic agents in the treatment of HIV infection and HIV-related injections in an animal. Recombinant vectors which express the mutant HIV Tat proteins described are also disclosed, as well as cell lines which product high yields of the mutant HIV. Also provided are cell lines that express enhanced levels of TAR mutant viruses relative to other TAR mutant infected cell lines. Levels of production are enhanced by the use of cell lines that express a transactivator protein, such as adenovirus transactivator EIA and/or EIB protein.

Abstract: A method for determining the capacity of a human sperm to fertilize a human egg is described by assessing sperm activation events in an in vitro assay using a non-mammalian egg extract, particularly a Xenopus laevis frog egg extract. Fertilizing capacity is assessed as a comparison of sperm decondensation, DNA synthesis and/or sperm recondensation as between a test sperm sample sperm and fertile sperm, such as a sperm sample from a proven fertile human male. The method employs results from the in vitro assay to also determine relative sufficiency or insufficiency of a sperm sample for fertilizing a human egg in human couples with a history of a diagnosed unexplained infertility from standard infertility diagnostic tests. The method may also be used to screen human sperm donors in human artificial insemination programs.

Abstract: The present invention involves the use of Tripterygium Wilfordii Hook F extracts in the treatment of rheumatoid arthritis. An alcohol extract of this plant (T2) inhibited antigen- and mitogen-stimulated proliferation of T cells and B cells, cell cycle progression, interleukin-2 (IL-2) production by T cells, immunoglobulin production by B cells and interleukin-2 mRNA production. T2 did not affect IL-2 receptor expression by T cells, IL-1 production by monocytes, the capacity of monocytes to present antigen, or signaling pathways. Inhibition could not be accounted for by nonspecific toxicity. These results support the conclusion that T2 exerts a powerful suppressive effect on human immune responses. Suppressing autoimmune disease is a most preferred embodiment of this invention.

Abstract: A system and method for assessing the minimum number of RNA:DNA sequence combinations whose properties need to be determined for selecting antisense oligonucleotide sequences that will form the most stable hybrid among all those possible in a given target mRNA sequence is provided.

Abstract: The present invention provides for the use of Tripterygium wilfordii Hook F extracts and purified components thereof in the treatment of inflammation or an immune disorder with concomitant lack of steroidal effect. Extracts of this plant (T2) bound to the glucocorticoid receptor and competitively inhibited glucocorticoid mediated cellular processes, such as dexamethasone binding to the glucocorticoid receptor, glucocorticoid mediated activation of target genes, dexamethasone dependent cellular growth, with concomitant inhibition of cyclooxygenase-2 induction and inflammatory processes such as the production of prostaglandin E.sub.2. The T2 extract components triptolide and tripdiolide were effective inhibitors. The particular advantage provided by the methods herein is the treatment or prevention of inflammation and the concomitant lack of steroidal agonist effects and NSAID side effects. Conditions treatable by the present methods include inflammation and immune disorders including autoimmune disease.

Abstract: Unique ecdysis triggering hormone nucleic acid molecules and ETH peptides/proteins having biological activity for promoting ecdysis in insects are disclosed. Methods of preparing the peptides/proteins by recombinant means, and use of the peptide/proteins in an insect controlling agent are also provided. Methods of inducing ecdysis using the sequences encoding the ETH peptides/proteins are outlined. Insecticidal preparations that are specific to insects that shed their skin, and that do not pose an environmental threat to humans or animals, are also disclosed employing the nucleic and molecules and peptides and proteins they encode. Processes employing the ETH nucleic acid encoding sequences to identify ETH receptors are also defined. The ETH receptors are employed in screening assays to select organic molecules capable of binding the ETH receptor and inducing ecdysis and eclosion, particularly in insects.

Abstract: A method for determining the capacity of a human sperm to fertilize a human egg is described by assessing sperm activation events in an in vitro assay using a non-mammalian egg extract, particularly a Xenopus laevis frog egg extract. Fertilizing capacity is assessed as a comparison of sperm decondensation, DNA synthesis and/or sperm recondensation as between a test sperm sample sperm and fertile sperm, such as a sperm sample from a proven fertile human male. The method employs results from the in vitro assay to also determine relative sufficiency or insufficiency of a sperm sample for fertilizing a human egg in human couples with a history of a diagnosed unexplained infertility from standard infertility diagnostic tests. The method may also be used to screen human sperm donors in human artificial insemination programs.

Abstract: Disclosed are compositions comprising non-steroid anti-inflammatory drugs (NSAID'S)complexed with zwitterionic or neutral phospholipids and having reduced gastrointestinal irritating effects and enhanced antipyretic analgesic, and antiinflammatory effects. Also disclosed are improved methods of using the complexes for treating fever, inflammation, and preventing platelet aggregation. In some embodiments, the anti-pyretic activity of sub-therapeutically used amounts of NSAID's are enhanced to elicit anti-pyretic activity in vivo when associated (noncovalently) with zwitterionic phospholipids, such as dipalmitoyl phosphatidyl choline.

Abstract: Unique ecdysis triggering hormone nucleic acid molecules and ETH peptides/proteins having biological activity for promoting ecdysis in insects are disclosed. Methods of preparing the peptides/proteins by recombinant means, and use of the peptide/proteins in an insect controlling agent are also provided. Methods of inducing ecdysis using the sequences encoding the ETH peptides/proteins are outlined. Insecticidal preparations that are specific to insects that shed their skin, and that do not pose an environmental threat to humans or animals, are also disclosed employing the nucleic and molecules and peptides and proteins they encode. Processes employing the ETH nucleic acid encoding sequences to identify ETH receptors are also defined. The ETH receptors are employed in screening assays to select organic molecules capable of binding the ETH receptor and inducing ecdysis and eclosion, particularly in insects.

Abstract: The present invention relates to the cloning, sequencing and characterization of a unique human epidermal surface antigen, ESA, and to methods for preparing and using the ESA gene and protein. The ESA gene is mapped to the region 17q11-12, on the long arm of chromosome 17, in the same area as the NF1 locus (the gene for von Recklinghausen neurofibromatosis). The mouse ESA has been located to chromosome 11. ESA mRNA is expressed in cultured keratinocytes and melanocytes, as well as in several carcinoma cell lines. Methods employing the antigen and/or DNA segments in diagnostic and therapeutic methods, including gene therapy, for the treatment of a variety of diseases, including cancer and autoimmunity, are disclosed. Methods for targeting molecules to the suprabasal epidermal cell layer are also presented.

Abstract: Transdominant HIV tat substitution and truncated gene mutants of 72 amino acid residues or less are disclosed. The mutated genes encode mutant Tat proteins which are capable of inhibiting the expression of the HIV-1 virus in the presence of an equimolar concentration of the wild type Tat protein in vitro. Therapeutic agents which include fused protein forms of the mutant proteins are also disclosed, as well as methods of preparing and using the therapeutic agents in the treatment of HIV infection and HIV-related injections in an animal. Recombinant vectors which express the mutant HIV Tat proteins described are also disclosed, as well as cell lines which product high yields of the mutant HIV.

Abstract: The invention relates to a cellular protein which is specific and has high affinity for nucleic acid sequences characteristic of an intact TAR RNA loop sequence of the HIV LTR TAR region. The invention also relates to a protein preparation having a protein of about 185 kD that is isolated from a mammalian cell nuclear extract preparation, most specifically a HeLa cell extract that is purified between 1,000-10,000 fold. The protein of about 185 kD is shown to regulate HIV viral gene expression by binding a TAR RNA region of an HIV LTR template, in the presence of a cofactor fraction (including at least a -100 kD cofactor), and a tat protein. A route for the development of immunodiagnostics for AIDS and related disorders may also be provided given the specific and high affinity of TRP-185 for HIV RNA.

Abstract: Improved compositions containing a visible coloring agent, such as a pigment or dye, together with a polymer or hydroxylated aliphate alcohol, and an active ingredient defined as a surfactant, a therapeutic agent or biocide, are disclosed. The detectable agent is readily visible under normal white light, and provides a technique for monitoring disturbed and undisturbed areas on a surface. Such is useful in the described methods for cleaning and/or decontaminating a surface, such as in the decontamination of equipment and clothing used during hazardous spill response. The compositions are adherent to a variety of different materials, including Teflon.RTM.. This makes the preparations particularly useful in the cleaning and decontamination of non-flat and curved surfaces, such as on protective garments.

Abstract: Esters or amides of a peptide, preferably a dipeptide, consisting essentially of natural or synthetic L-amino acids with hydrophobic side chains were found to have specific cellular toxicities. Preferable amino acids of the peptide are leucine, phenylalanine valine, isoleucine, alanine, proline, glycine or aspartic acid beta methyl ester. Preferable dipeptides are L leucyl L-leucine, L-leucyl L-phenylalanine, L-valyl L-phenylalanine, L-leucyl L-isoleucine, L-phenylalanyl L-phenylalanine, L-valyl L-leucine, L-leucyl L-alanine, L-valyl L-valine, L-phenylalanyl L leucine, L prolyl L-leucine, L-leucyl L-valine, L-phenylalanyl L-valine, L glycyl L-leucine, L-leucyl L-glycine, glycyl L-phenylalanine and L-aspartyl beta methyl ester L-phenylalanine. Most preferable dipeptides are L-leucyl L-leucine, L-leucyl L-phenylalanine, L-valyl L-phenylalanine, L-phenylalanyl L-leucine, L-leucyl L-isoleucine L-phenylalanyl L-phenylalanine and L-valyl L-leucine.

Abstract: Compositions that include as an active ingredient an effective concentration of a halogenated mevalonate preparation, particularly, Fmev (fluoromevalonate) are provided. The pharmacological activity of halogenated mevalonate for inhibiting ras-dependent cell growth, particularly ras-dependent tumor cell growth, is described. Methods for using preparations including a therapeutically effective concentration of Fmev for the inhibition of ras-dependent cell growth, as well as in the treatment and inhibition of ras-dependent tumors is also disclosed. The claimed compositions may be provided in liquid, salve, tablet, or capsule form, as well as other forms suitable for administration to an animal.