Abstract: The invention is related to polynucleotide-based cytomegalovirus vaccines. In particular, the invention is plasmids operably encoding HCMV antigens, in which the naturally-occurring coding regions for the HCMV antigens have been modified for improved translation in human or other mammalian cells through codon optimization. HCMV antigens which are useful in the invention include, but are not limited to pp65, glycoprotein B (gB), IE1, and fragments, variants or derivatives of either of these antigens. In certain embodiments, sequences have been deleted, e.g., the Arg435-Lys438 putative kinase in pp65 and the membrane anchor and endocellular domains in gB. The invention is further directed to methods to induce an immune response to HCMV in a mammal, for example, a human, comprising delivering a plasmid encoding a codon-optimized HCMV antigen as described above.

Abstract: The invention provides adjuvants, immunogenic compositions, and methods useful for polynucleotide-based vaccination and immune response. In particular, the invention provides an adjuvant of cytofectin:co-lipid mixture wherein cytofectin is GAP-DMORIE.

Abstract: This invention relates to a method for systemic immune activation which is effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in a mammal. The method is particularly effective for protecting a mammal from herpes simplex virus. Also disclosed are therapeutic compositions useful in such a method.

Abstract: A reactor and methods of use are disclosed for amplification of an amplicon. The reactor includes a housing having a fluid path with a fluid inlet and a fluid outlet and one or more reaction chambers suitable for housing the amplicon. The reaction chambers are positioned within the housing in thermal communication with a fluid flowing in the fluid path to heat and/or cool the reaction chambers and the inside of the reaction chambers are coated with or are a plastic material. A variable temperature fluid source is in fluid communication with the fluid inlet and the fluid source is configured to provide fluid at temperatures suitable for amplification, including a denature temperature, an anneal temperature, and an extension temperature. A controller is coupled to the variable temperature fluid source to control a fluid temperature within the fluid path by controlling the variable temperature fluid source.

Abstract: The invention relates to a method for manufacturing cell delivery particles, pharmaceutical component-particle dispersions, compositions comprising cell delivery particles and pharmaceutical compositions comprising pharmaceutical component-particle dispersions. The method comprises homogenization of mixtures comprising amphiphilic components and a block copolymer to form stable particles. The invention is also directed to cell delivery particles and pharmaceutical component-particle dispersions produced by the claimed methods and compositions comprising same. In certain embodiments, the cell delivery particles may further comprise co-lipids. The invention further relates to methods of generating an immune response, treating or preventing a disease or condition, or delivering a biologically active molecule to cells in vitro comprising administration of the pharmaceutical compositions described herein.

Abstract: The present inventors have developed a novel composition and method for inhibiting inflammation and treating of symptoms of tissue ischemia, including that associated with peripheral and cardiac vascular disease by local administration of a pharmaceutical composition including an effective amount of a poloxamer.

Abstract: The invention is related to polynucleotide-based cytomegalovirus vaccines. In particular, the invention is plasmids operably encoding HCMV antigens, in which the naturally-occurring coding regions for the HCMV antigens have been modified for improved translation in human or other mammalian cells through codon optimization. HCMV antigens which are useful in the invention include, but are not limited to pp65, glycoprotein B (gB), IE1, and fragments, variants or derivatives of either of these antigens. In certain embodiments, sequences have been deleted, e.g., the Arg435-Lys438 putative kinase in pp65 and the membrane anchor and endocellular domains in gB. The invention is further directed to methods to induce an immune response to HCMV in a mammal, for example, a human, comprising delivering a plasmid encoding a codon-optimized HCMV antigen as described above.

Abstract: This invention relates to a method for systemic immune activation which is effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in a mammal. The method is particularly effective for protecting a mammal from herpes simplex virus. Also disclosed are therapeutic compositions useful in such a method.

Abstract: The invention relates to a process for purifying plasmid DNA. The invention also relates to a DNA product made by the process of the invention. The DNA product is suitable for pharmaceutical use.

Abstract: A recombinant vector containing infectious genome of human cytomegalovirus (HCMV) and being useful for the production of reconstituted HCMV virus retaining phenotypic characteristics of a clinical virus isolate including the ability to grow on endothelial cells and to induce microfusion is characterized in that it is obtainable by inserting DNA from a clinical isolate of HCMV virus into a bacterial cloning vehicle. Such vector can be used e.g., for production of reconstituted HCMV virus retaining the phenotypic characteristics of a parental clinical isolate and for studying genes and functions of genes of HCMV virus. A further aspect are mutant viruses and inter alia their use for studying aspects of infectivity of HCMV virus.

Abstract: The present invention is directed to enhancing the immune response of a human in need of protection against IV infection by administering in vivo, into a tissue of the human, at least one polynucleotide comprising one or more regions of nucleic acid encoding an IV protein or a fragment, a variant, or a derivative thereof. The present invention is further directed to enhancing the immune response of a human in need of protection against IV infection by administering, in vivo, into a tissue of the human, at least one IV protein or a fragment, a variant, or derivative thereof. The IV protein can be, for example, in purified form or can be an inactivated IV, such as those present in inactivated IV vaccines. The polynucleotide is incorporated into the cells of the human in vivo, and an immunologically effective amount of an immunogenic epitope of an IV, or a fragment, variant, or derivative thereof is produced in vivo.

Abstract: The present invention is directed to enhancing the immune response of a human in need of protection against IV infection by administering in vivo, into a tissue of the human, at least one polynucleotide comprising one or more regions of nucleic acid encoding an IV protein or a fragment, a variant, or a derivative thereof. The present invention is further directed to enhancing the immune response of a human in need of protection against IV infection by administering, in vivo, into a tissue of the human, at least one IV protein or a fragment, a variant, or derivative thereof. The IV protein can be, for example, in purified form or can be an inactivated IV, such as those present in inactivated IV vaccines. The polynucleotide is incorporated into the cells of the human in vivo, and an immunologically effective amount of an immunogenic epitope of an IV, or a fragment, variant, or derivative thereof is produced in vivo.

Abstract: This invention relates to a method for systemic immune activation which is effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in a mammal. The method is particularly effective for protecting a mammal from herpes simplex virus. Also disclosed are therapeutic compositions useful in such a method.

Abstract: This invention relates to a method for systemic immune activation which is effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in a mammal. The method is particularly effective for protecting a mammal from herpes simplex virus. Also disclosed are therapeutic compositions useful in such a method.

Abstract: This invention relates to a method for systemic immune activation which is effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in a mammal. The method is particularly effective for protecting a mammal from herpes simplex virus. Also disclosed are therapeutic compositions useful in such a method.

Abstract: A recombinant vector containing infectious genome of human cytomegalovirus (HCMV) and being useful for the production of reconstituted HCMV virus retaining phenotypic characteristics of a clinical virus isolate including the ability to grow on endothelial cells and to induce microfusion is characterized in that it is obtainable by inserting DNA from a clinical isolate of HCMV virus into a bacterial cloning vehicle. Such vector can be used e.g., for production of reconstituted HCMV virus retaining the phenotypic characteristics of a parental clinical isolate and for studying genes and functions of genes of HCMV virus. A further aspect are mutant viruses and inter alia their use for studying aspects of infectivity of HCMV virus.

Abstract: This invention relates to a method for systemic immune activation which is effective for eliciting both a systemic, non-antigen specific immune response and a strong antigen-specific immune response in a mammal. The method is particularly effective for protecting a mammal from herpes simplex virus. Also disclosed are therapeutic compositions useful in such a method.

Abstract: The invention provides adjuvants, immunogenic compositions, and methods useful for polynucleotide-based vaccination and immune response. In particular, the invention provides an adjuvant of cytofectin:co-lipid mixture wherein cytofectin is GAP-DMORIE.

Abstract: The present inventors have developed a novel approach for efficient delivery of angiogenic factors to the cardiac and peripheral vasculature that avoids problems with toxicity inherent to existing delivery technologies. Vectors carrying coding sequences for angiogenic agents including Del-1 or VEGF, or both, can be formulated with poloxamers or other polymers for delivery into ischemic tissue and delivered to areas of peripheral ischemia in a flow to no-flow pattern and to the heart by retrograde venous perfusion.

Abstract: The disclosure provides adjuvants, immunogenic compositions, and methods useful for vaccination and immune response. In particular, the disclosure provides a class of adjuvants comprising cationic lipid:co-lipid mixtures and methods for delivering formulated compositions.