Abstract: This application covers a novel PEGylated interferon and a novel crystalline form of interferon which are useful, inter alia, for detailed structural analysis of interferon as well as treatment and prevention of viral infections and hyperproliferative diseases such as leukemia.

Abstract: A method and pharmaceutical composition for the enhancement of transfer of a therapeutic agent to a cell wherein the therapeutic agent is formulated in a buffer comprising a compound of Formula I: wherein: n is an integer from 2-8; X1 is a cholic acid group or deoxycholic acid group; and X2 and X3 are each independently selected from the group consisting of a cholic acid group, a deoxycholic acid group, and a saccharide group, wherein the saccharide group is selected from the group consisting of pentose monosaccharide groups, hexose monosaccharide groups, pentose-pentose disaccharide groups, hexose-hexose disaccharide groups, pentose-hexose disaccharide groups, and hexose-pentose disaccharide groups; and wherein at least one of X2 and X3 is a saccharide group.

Abstract: A method and pharmaceutical composition for the enhancement of transfer of a therapeutic agent to a cell wherein the therapeutic agent is formulated in a buffer comprising a compound of Formula I: wherein: n is an integer from 2-8; X1 is a cholic acid group or deoxycholic acid group; and X2 and X3 are each independently selected from the group consisting of a cholic acid group, a deoxycholic acid group, and a saccharide group, wherein the saccharide group is selected from the group consisting of pentose monosaccharide groups, hexose monosaccharide groups, pentose-pentose disaccharide groups, hexose-hexose disaccharide groups, pentose-hexose disaccharide groups, and hexose-pentose disaccharide groups; and wherein at least one of X2 and X3 is a saccharide group.

Abstract: A method and pharmaceutical composition for the enhancement of transfer of a therapeutic agent to a cell wherein the therapeutic agent is formulated in a buffer comprising a compound of Formula I: wherein: n is an integer from 2-8; X1 is a cholic acid group or deoxycholic acid group; and X2 and X3 are each independently selected from the group consisting of a cholic acid group, a deoxycholic acid group, and a saccharide group, wherein the saccharide group is selected from the group consisting of pentose monosaccharide groups, hexose monosaccharide groups, pentose-pentose disaccharide groups, hexose-hexose disaccharide groups, pentose-hexose disaccharide groups, and hexose-pentose disaccharide groups; and wherein at least one of X2 and X3 is a saccharide group.

Abstract: This invention provides methods and compositions for enhancing transfer of an agent into a cell. The agents can include polypeptides, polynucleotides such as genes and antisense nucleic acids, and other molecules. In some embodiments, the agents are modulating agents that can modulate a cellular activity or function when introduced into the cell. The methods and compositions are useful for introducing agents into individual cells, as well as cells that are present as a tissue or organ.

Abstract: The present invention is directed to compositions and methods for the delivery of interferon polypeptides. The invention provides recombinant viral and non-viral vectors for the selective expression of interferon polypeptides in particular cell or tissue types. The invention further provides pharmaceutically acceptable formulations of such vectors for administration to mammalian subjects. The invention further provides methods of treatment of diseases in mammalian organisms through the delivery of recombinant vectors selectively expressing interferon polypeptides.

Abstract: The present invention is directed to compositions and methods of treating cancer by gene therapy using a therapeutic gene formulated in a buffer comprising a delivery-enhancing agent. The delivery-enhancing agents of the invention can be used to formulate therapeutic or diagnostic agents, such as proteins, nucleic acids, antisense RNA, small molecules, etc., for administration to any tissue or organ having an epithelial membrane. The delivery-enhancing agents include detergents, alcohols, surfactants and other molecules.

Abstract: Methods and pharmaceutical compositions for administering interferon therapy to tissues or organs having an epithelial cell layer are provided. A recombinant adenoviral vector encoding an interferon gene is administered to the target tissue or organ in combination with treatment with a delivery enhancing agent which increases the transduction of the cells of the target tissues or organs by the vector. The methods and combinations are useful in the treatment of cancers and other conditions responsive to interferon therapy. An exemplary method comprises the transurethral intravesical administration to the bladder of a therapeutically effective amount of a pharmaceutical composition comprising an adenoviral vector encoding alpha-interferon and SYN3 or a SYN3 homolog or analog. In the urinary bladder, as much as a 1,000 to 10,000 fold increase in interferon gene expression has been achieved by use of the combination of SYN3 with the recombinant adenoviral vector as compared to the use of the vector without SYN3.

Abstract: The present invention is directed to compositions and methods for the delivery of interferon polypeptides. The invention provides recombinant viral and non-viral vectors for the selective expression of interferon polypeptides in particular cell or tissue types. The invention further provides pharmaceutically acceptable formulations of such vectors for administration to mammalian subjects. The invention further provides methods of treatment of diseases in mammalian organisms through the delivery of recombinant vectors selectively expressing interferon polypeptides.

Abstract: This invention provides methods and compositions for enhancing transfer of an agent into a cell. The agents can include polypeptides, polynucleotides such as genes and antisense nucleic acids, and other molecules. In some embodiments, the agents are modulating agents that can modulate a cellular activity or function when introduced into the cell. The methods and compositions are useful for introducing agents into individual cells, as well as cells that are present as a tissue or organ.

Abstract: This invention provides methods and compositions for enhancing transfer of an agent into a cell. The agents can include polypeptides, polynucleotides such as genes and antisense nucleic acids, and other molecules. In some embodiments, the agents are modulating agents that can modulate a cellular activity or function when introduced into the cell. The methods and compositions are useful for introducing agents into individual cells, as well as cells that are present as a tissue or organ.

Abstract: Methods are provided for treating cancer, comprising administering (1) a farnesyl protein transferase inhibitor in conjunction with (2) an additional Ras signaling pathway inhibitor to induce cancer cell death and tumor regression.

Abstract: This invention provides methods and compositions for enhancing transfer of an agent into a cell. The agents can include polypeptides, polynucleotides such as genes and antisense nucleic acids, and other molecules. In some embodiments, the agents are modulating agents that can modulate a cellular activity or function when introduced into the cell. The methods and compositions are useful for introducing agents into individual cells, as well as cells that are present as a tissue or organ.

Abstract: A method for making crystals of zinc interferon alpha-2, and the use thereof in depot formulations, are disclosed.

Abstract: This invention provides a crystalline form of recombinant human granulocyte-macrophage colony-stimulating factor (r-h-GM-CSF) and methods for making such crystals.

Abstract: A method for making crystals of interferon alpha-2 and the use thereof in depot formulations are disclosed.

Abstract: The present invention provides for crystalline zinc-interferon alfa-2 (IFN .alpha.-2) having a monoclinic morphology. The present invention further provides for crystalline cobalt-IFN .alpha.-2, crystalline calcium-IFN .alpha.-2, and crystalline IFN .alpha.-2 having a serum half-life of at least about 12 hours when injected into a primate. The present invention further provides for a method for producing a crystalline IFN .alpha.-2 comprising forming a soluble metal-IFN .alpha.-2 complex, and equilibrating the soluble metal-IFN .alpha.-2 complex in solution with an acetate salt of the metal under conditions that will cause the metal-IFN .alpha.-2 solution to become supersaturated and form crystalline metal-IFN .alpha.-2. The present invention also includes crystalline metal-alfa interferon having monoclinic, plate and needle morphologies.

Abstract: This invention provides a crystalline form of recombinant human granulocyte-macrophage colony-stimulating factor (r-h-GM-CSF) and methods for making such crystals.

Abstract: Antiandrogenic peptidyl esters, particularly tri-peptidyl esters, of the active metabolite of flutamide are disclosed.

Abstract: A method of purifying a polypeptide having a physiological activity such as one having interferon activities from a culture mixture of a microorganism obtained by a recombinant DNA technique and capable of producing the polypeptide is disclosed. The method comprises subjecting the cultured cells to extraction and purification in the presence of a salt of zinc or copper and polyethyleneimine thereby inhibiting decomposition and denaturation of the polypeptide. The extracted polypeptide can be further purified by column chromatographies using a column containing an anion exchange resin, column containing a cation exchange resin and column containing a gel filtration resin.