Abstract: Aspects of the present invention relate to electroporation devices and methods of using same to effectively facilitate the introduction of a biomolecule into cells of a selected tissue in a body, in particular skin such as intradermic or subcutaneous tissue. In some aspects, the present invention is a skin EP device, which produces a pulse of energy and delivers same to the skin tissue using a skin electrode array and maintains a constant current in the same skin tissue based on user input, including a preset current, and allows the storage and acquisition of current waveform data.

Abstract: Compositions and kits comprising a nucleotide sequence that encodes GHRH and a nucleotide sequence that encodes GnRH and compositions and kits comprising a GHRH protein and GnRH protein are disclosed. Use of such compositions and kits in methods of enhancing fertility in mammals comprising the step of administering said compositions to the mammal are disclosed.

Abstract: There are provided methods of generating antibodies in a mammal against recombinant antigens using DNA plasmids capable of expressing said antigens in cells of said mammal, comprising: injecting into tissue of said mammal a DNA plasmid comprising an encoding sequence operably linked to a promoter, electroporating said tissue with an electroporation device capable of delivering an electrical pulse effective to electroporate cells of said tissue to allow entry of said DNA plasmid and expression of said antigen, and allowing said mammal to respond to said expressed antigen in order to generate antibodies to said antigen. Furthermore, there are provided methods of isolating antibodies specific against desired antigens wherein said antibodies are generated in a mammal using DNA plasmids capable of expressing said antigens.

Abstract: One aspect of the current invention is an optimized synthetic mammalian expression plasmid with a mutated origin of replication (e.g. “mut” family of plasmids) comprising a therapeutic element, and a replication element. The therapeutic elements of this plasmid are operatively linked and located in a first operatively-linked arrangement. Additionally, the optimized synthetic mammalian expression plasmid comprises replication elements, wherein the replication elements are operatively linked and located in a second operatively-linked arrangement. The first-operatively-linked arrangement and the second-operatively-linked arrangement comprise a circular structure of the codon optimized synthetic mammalian expression plasmid.

Abstract: Composition and method for stimulating angiogenesis, stimulating myogenesis, upregulating angiogenic factors and angiopoietins, and treating the muscular and vascular complications of diabetes. Overall, the embodiments of the invention can be accomplished by delivering a heterologous nucleic acid sequence encoding insulin-like growth factor I (“IGF-I”) or a functional biological equivalent thereof into the cells of the subject and allowing expression of the encoded gene to occur while the modified cells are within the subject. The nucleic acid sequence maybe delivered by a vector system including a synthetic myogenic promoter and a 3? untranslated region. The preferred method to deliver the constitutive or inducible nucleic acid encoding sequences of IGF-I or the functional biological equivalents thereof is directly into the cells of the subject by the process of in vivo electroporation.

Abstract: An electroporation device which may be used to effectively facilitate the introduction of a macromolecule into cells of a selected tissue in a body or plant. The electroporation device comprises an electro-kinetic device (“EKD”) whose operation is specified by software or firmware. The EKD produces a series of programmable constant-current pulse patterns between electrodes in an array based on user control and input of the pulse parameters and allows the storage and acquisition of current waveform data. The electroporation device also comprises a replaceable electrode disk having an array of needle electrodes, a central injection channel for an injection needle, and a removable guide disk.

Abstract: One aspect of the current invention is a method of preventing and/or treating arthritis and/or preventing or treating lameness in a subject. Additionally, subject quality of life and welfare, and body condition scores are improved by utilizing methodology that administers the nucleic acid expression construct encoding a GHRH or functional biological equivalent to a subject through a parenteral route of administration. Following a single dose of nucleic acid expression vector, subjects are healthier and effects are demonstrated long term without additional administration(s) of the expression construct.

Abstract: The present invention pertains to compositions and methods useful for treating anemia and other effects that are commonly associated in cancer bearing animals. The invention is accomplished by delivering an effective amount of a nucleic acid expression construct that encodes a GHRH or functional biological equivalent thereof into a tissue of an animal and allowing expression of the encoded gene in the animal.

Abstract: This invention is related to compositions and methods for decreasing cholesterol levels in a subject. The method utilizes a nucleic acid expression construct that encodes a growth-hormone-releasing-hormone (“GHRH”) that is delivered into a tissue of the subject, wherein, GHRH is expressed in vivo in the subject.

Abstract: One aspect of the current invention is an optimized synthetic mammalian expression plasmid with a mutated origin of replication (e.g. “mut” family of plasmids). This new plasmid comprises a therapeutic element, and a replication element. The therapeutic element of the new plasmid comprises a eukaryotic promoter; a 5? untranslated region (“UTR”); a codon-optimized-eukaryotic therapeutic gene sequence; and a poly adenylation signal. The therapeutic elements of this plasmid are operatively linked and located in a first operatively-linked arrangement. Additionally, the optimized synthetic mammalian expression plasmid comprises replication elements, wherein the replication elements are operatively linked and located in a second operatively-linked arrangement. The replication elements comprise a selectable marker gene promoter, a ribosomal binding site, a selectable marker gene sequence, and an improved origin of replication.

Abstract: The present invention relates to a modular electrode system, and its use, for facilitating the introduction of a macromolecule into cells of a selected tissue in a body or plant. The modular electrode system comprises a non-symmetrically arranged plurality of needle electrodes; a hypodermic needle; an electrical connector that provides a conductive link from a programmable constant-current pulse controller to the plurality of needle electrodes; and a power source. In a preferred embodiment of the present invention, an operator can grasp the plurality of needle electrodes that are mounted on a support structure and firmly insert the them into the selected tissue in a body or plant. The macromolecules are then delivered via the hypodermic needle into the selected tissue. The programmable constant-current pulse controller is activated and constant-current electrical pulse is applied to the plurality of needle electrodes.

Abstract: The present invention relates to DNA vaccines that are capable of generating a protective immune response in mammals against a pox virus, and comprises at least one DNA plasmid capable of expressing a plurality of VACV MV antigens, and at least one DNA plasmid capable of expressing a plurality of VACV EV antigens. Also, the present invention relates to methods of inducing a protective immune response in a mammal to pox virus, including a neutralizing antibody response, comprising: injecting into tissue of said mammal said DNA vaccine.

Abstract: There are provided methods of generating antibodies in a mammal against recombinant antigens using DNA plasmids capable of expressing said antigens in cells of said mammal, comprising: injecting into tissue of said mammal a DNA plasmid comprising an encoding sequence operably linked to a promoter, electroporating said tissue with an electroporation device capable of delivering an electrical pulse effective to electroporate cells of said tissue to allow entry of said DNA plasmid and expression of said antigen, and allowing said mammal to respond to said expressed antigen in order to generate antibodies to said antigen. Furthermore, there are provided methods of isolating antibodies specific against desired antigens wherein said antibodies are generated in a mammal using DNA plasmids capable of expressing said antigens.

Abstract: One aspect of the current invention is a method designing and using species-specific or synthetic signal peptides and GHRH sequences for the purpose of preventing and/or treating chronic illness in a subject by utilizing methodology that administers a single dose of nucleic acid expression vector or nucleic acid expression construct encoding a GHRH or functional biological equivalent to a subject through a parenteral route of administration.

Abstract: Pharmaceutical composition comprising compounds and/or compositions useful to inhibit viral replication are disclosed.

Abstract: A composition and a method of increasing growth hormone (“GH”) values in a canine or dog, and more specifically, a canine- or dog-specific growth hormone releasing hormone (“dGHRH”), or functional biological equivalent thereof. The dGHRH is an isolated composition or a nucleic acid molecule that encodes the dGHRH or functional biological equivalent. Also, a method for delivering the composition of this invention to a subject, wherein the dGHRH increases the level of growth hormone (“GH”) secretion in a recipient subject, such as a canine or dog.

Abstract: A composition and a method of increasing growth hormone (“GH”) values in a canine or dog, and more specifically, a canine- or dog-specific growth hormone releasing hormone (“dGHRH”), or functional biological equivalent thereof. The dGHRH is an isolated composition or a nucleic acid molecule that encodes the dGHRH or functional biological equivalent. Also, a method for delivering the composition of this invention to a subject, wherein the dGHRH increases the level of growth hormone (“GH”) secretion in a recipient subject, such as a canine or dog.

Abstract: One aspect of the current invention is an optimized synthetic mammalian expression plasmid (e.g. pAV0201). This new plasmid comprise a therapeutic element, and a replication element. The therapeutic element of the new plasmid comprises a eukaryotic promoter; a 5? untranslated region (“UTR”); a codon-optimized-eukaryotic therapeutic gene sequence; and a poly adenylation signal. The therapeutic elements of this plasmid are operatively linked and located in a first operatively-linked arrangement. Additionally, the optimized synthetic mammalian expression plasmid comprises replication elements, wherein the replication elements are operatively linked and located in a second operatively-linked arrangement. The replication elements comprise a selectable marker gene promoter, a ribosomal binding site, and an origin of replication. The first-operatively-linked arrangement and the second-operatively-linked arrangement comprise a circular structure of the codon optimized synthetic mammalian expression plasmid.

Abstract: Pharmaceutical composition comprising compounds and/or compositions useful to inhibit HIV replication are disclosed. Methods of treating individuals infected with HIV are disclosed. Methods of preventing HIV infection in high risk individuals are disclosed.