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Papers by Robert Malone

Research paper thumbnail of Dexamethasone enhancement of gene expression after direct hepatic DNA injection

Journal of Biological Chemistry, 1994

Research paper thumbnail of Hospitalized COVID-19 Patients Treated With Celecoxib and High Dose Famotidine Adjuvant Therapy Show Significant Clinical Responses

BACKGROUND: Up to 80% of SARS-CoV-2 positive patients are asymptomatic and do not appear to progr... more BACKGROUND: Up to 80% of SARS-CoV-2 positive patients are asymptomatic and do not appear to progress to COVID-19. SARS-CoV-2 infection is not sufficient for development of COVID-19 disease; this may reflect differences in host inflammatory responses to infection. COX-2 expression is transcriptionally upregulated by SARS nucleocapsid N protein, and COVID-19 is associated with markedly elevated levels of prostaglandin E2 (PGE2). PGE2 modulates a wide variety of innate and adaptive inflammatory responses including mast cell activation. SARS-CoV-2 infection-associated mast cell degranulation may play a role in development of COVID-19. A randomized trial of hospitalized COVID-19 cases has demonstrated that COX-2 protein antagonist celecoxib dampened systemic PGE2 levels, prevented clinical deterioration, and was associated with rapid pulmonary CT-chest improvement. High doses of famotidine, a histamine H2 receptor antagonist/inverse agonist reduces severity of COVID-19 symptoms. We hypot...

Research paper thumbnail of Medical Countermeasures Analysis of 2019-nCoV and Vaccine Risks for Antibody-Dependent Enhancement (ADE)

Background: In 80% of patients, COVID-19 presents as mild disease1,2. 20% of cases develop severe... more Background: In 80% of patients, COVID-19 presents as mild disease1,2. 20% of cases develop severe (13%) or critical (6%) illness. More severe forms of COVID-19 present as clinical severe acute respiratory syndrome, but include a T-predominant lymphopenia3, high circulating levels of proinflammatory cytokines and chemokines, accumulation of neutrophils and macrophages in lungs, and immune dysregulation including immunosuppression4. Methods: All major SARS-CoV-2 proteins were characterized using an amino acid residue variation analysis method. Results predict that most SARS-CoV-2 proteins are evolutionary constrained, with the exception of the spike (S) protein extended outer surface. Results were interpreted based on known SARS-like coronavirus virology and pathophysiology, with a focus on medical countermeasure development implications. Findings: Non-neutralizing antibodies to variable S domains may enable an alternative infection pathway via Fc receptor-mediated uptake. This may be...

Research paper thumbnail of Molecular evolution of Zika virus as it crossed the Pacific to the Americas

Cladistics, 2016

Zika virus was previously considered to cause only a benign infection in humans. Studies of recen... more Zika virus was previously considered to cause only a benign infection in humans. Studies of recent outbreaks of Zika virus in the Pacific, South America, Mexico and the Caribbean have associated the virus with severe neuropathology. Viral evolution may be one factor contributing to an apparent change in Zika disease as it spread from Southeast Asia across the Pacific to the Americas. To address this possibility, we have employed computational tools to compare the phylogeny, geography, immunology and RNA structure of Zika virus isolates from Africa, Asia, the Pacific and the Americas. In doing so, we compare and contrast methods and results for tree search and rooting of Zika virus phylogenies. In some phylogenetic analyses we find support for the hypothesis that there is a deep common ancestor between African and Asian clades (the "Asia/Africa" hypothesis). In other phylogenetic analyses, we find that Asian lineages are descendent from African lineages (the "out of Africa" hypothesis). In addition, we identify and evaluate key mutations in viral envelope protein coding and untranslated terminal RNA regions. We find stepwise mutations that have altered both immunological motif sets and regulatory sequence elements. Both of these sets of changes distinguish viruses found in Africa from those in the emergent Asia-Pacific-Americas lineage. These findings support the working hypothesis that mutations acquired by Zika virus in the Pacific and Americas contribute to changes in pathology. These results can inform experiments required to elucidate the role of viral genetic evolution in changes in neuropathology, including microcephaly and other neurological and skeletomuscular issues in infants, and Guillain-Barr e syndrome in adults.

Research paper thumbnail of Compounds and methods for enhancing delivery of free polynucleotide

Research paper thumbnail of ***Withdrawn Application as Per the Latest Uspto Withdrawn List***Expression of Exogenous Polynucleotide Sequences in a Vertebrate

Research paper thumbnail of Method for gene transfection and vaccination through skin using electropermeabilization

Research paper thumbnail of Process for Enhancing Electric Field-Mediated Delivery of Biological Materials Into Cells

Research paper thumbnail of Zika Fetal Neuropathogenesis: Etiology of a Viral Syndrome

The ongoing Zika Virus epidemic in the Americas, and the observed association with both fetal abn... more The ongoing Zika Virus epidemic in the Americas, and the observed association with both fetal abnormalities (primary microcephaly) and adult autoimmune pathology (Guillain-Barré syndrome) has brought attention to this neglected pathogen. While initial case studies generated significant interest in the Zika virus outbreak, larger prospective epidemiology and basic virology studies examining the mechanisms of Zika viral infection and associated pathophysiology are only now starting to be published. In this review, we analyze Zika fetal neuropathogenesis from a comparative pathology perspective, using the historic metaphor of “TORCH” viral pathogenesis to provide context. By drawing parallels to other viral infections of the fetus, we identify common themes and mechanisms that may illuminate the observed pathology. The existing data on the susceptibility of various cells to both Zika and other flavivirus infections are summarized. Finally, we highlight relevant aspects of the known mol...

Research paper thumbnail of Polyfunctional Cationic Cytofectins, Formulations and Methods for Generating Active Cytofectin:Polynucleotide Transfection Complexes

Research paper thumbnail of In vivo translation delivering antisense nucleotides; elicit-ing immune response to poorly immunogenic viral proteins

Research paper thumbnail of DNA vaccines for eliciting a mucosal immune response

Research paper thumbnail of Zika Virus Disease: A Simple Model Approach to Rapid Impact Assessment

There has been substantial media attention regarding Zika infection as a threat to pregnancy, pro... more There has been substantial media attention regarding Zika infection as a threat to pregnancy, prompted by WHOs declaration of a Public Health Event of International Concern (PHEIC). Here we present a simple risk assessment model for two states within the continental United States at-risk for autochthonous transmission of Zika virus, Texas and Florida. Our simple impact assessment model is partially validating at this early interval in the crisis.

Research paper thumbnail of Producing antibodies directed to protein of hiv virus in mice, dna plasmids

Research paper thumbnail of Lipid-mediated polynucleotide administration to deliver a biologically active peptide and to induce a cellular immune response

Research paper thumbnail of Methods of delivering a physiologically active polypeptide to a mammal

Research paper thumbnail of Generation of antibodies through lipid mediated DNA delivery

Research paper thumbnail of Biological injections into mamalian muscle of dna to express a therapeutic protein, polypeptide or peptide; vaccines; administering a dystrophin gene correcting muscular dystrophy

Research paper thumbnail of Generation of an immune response to a pathogen

Research paper thumbnail of Expression of exogenous polynucleotide sequences in a vertebrate

Research paper thumbnail of Dexamethasone enhancement of gene expression after direct hepatic DNA injection

Journal of Biological Chemistry, 1994

Research paper thumbnail of Hospitalized COVID-19 Patients Treated With Celecoxib and High Dose Famotidine Adjuvant Therapy Show Significant Clinical Responses

BACKGROUND: Up to 80% of SARS-CoV-2 positive patients are asymptomatic and do not appear to progr... more BACKGROUND: Up to 80% of SARS-CoV-2 positive patients are asymptomatic and do not appear to progress to COVID-19. SARS-CoV-2 infection is not sufficient for development of COVID-19 disease; this may reflect differences in host inflammatory responses to infection. COX-2 expression is transcriptionally upregulated by SARS nucleocapsid N protein, and COVID-19 is associated with markedly elevated levels of prostaglandin E2 (PGE2). PGE2 modulates a wide variety of innate and adaptive inflammatory responses including mast cell activation. SARS-CoV-2 infection-associated mast cell degranulation may play a role in development of COVID-19. A randomized trial of hospitalized COVID-19 cases has demonstrated that COX-2 protein antagonist celecoxib dampened systemic PGE2 levels, prevented clinical deterioration, and was associated with rapid pulmonary CT-chest improvement. High doses of famotidine, a histamine H2 receptor antagonist/inverse agonist reduces severity of COVID-19 symptoms. We hypot...

Research paper thumbnail of Medical Countermeasures Analysis of 2019-nCoV and Vaccine Risks for Antibody-Dependent Enhancement (ADE)

Background: In 80% of patients, COVID-19 presents as mild disease1,2. 20% of cases develop severe... more Background: In 80% of patients, COVID-19 presents as mild disease1,2. 20% of cases develop severe (13%) or critical (6%) illness. More severe forms of COVID-19 present as clinical severe acute respiratory syndrome, but include a T-predominant lymphopenia3, high circulating levels of proinflammatory cytokines and chemokines, accumulation of neutrophils and macrophages in lungs, and immune dysregulation including immunosuppression4. Methods: All major SARS-CoV-2 proteins were characterized using an amino acid residue variation analysis method. Results predict that most SARS-CoV-2 proteins are evolutionary constrained, with the exception of the spike (S) protein extended outer surface. Results were interpreted based on known SARS-like coronavirus virology and pathophysiology, with a focus on medical countermeasure development implications. Findings: Non-neutralizing antibodies to variable S domains may enable an alternative infection pathway via Fc receptor-mediated uptake. This may be...

Research paper thumbnail of Molecular evolution of Zika virus as it crossed the Pacific to the Americas

Cladistics, 2016

Zika virus was previously considered to cause only a benign infection in humans. Studies of recen... more Zika virus was previously considered to cause only a benign infection in humans. Studies of recent outbreaks of Zika virus in the Pacific, South America, Mexico and the Caribbean have associated the virus with severe neuropathology. Viral evolution may be one factor contributing to an apparent change in Zika disease as it spread from Southeast Asia across the Pacific to the Americas. To address this possibility, we have employed computational tools to compare the phylogeny, geography, immunology and RNA structure of Zika virus isolates from Africa, Asia, the Pacific and the Americas. In doing so, we compare and contrast methods and results for tree search and rooting of Zika virus phylogenies. In some phylogenetic analyses we find support for the hypothesis that there is a deep common ancestor between African and Asian clades (the "Asia/Africa" hypothesis). In other phylogenetic analyses, we find that Asian lineages are descendent from African lineages (the "out of Africa" hypothesis). In addition, we identify and evaluate key mutations in viral envelope protein coding and untranslated terminal RNA regions. We find stepwise mutations that have altered both immunological motif sets and regulatory sequence elements. Both of these sets of changes distinguish viruses found in Africa from those in the emergent Asia-Pacific-Americas lineage. These findings support the working hypothesis that mutations acquired by Zika virus in the Pacific and Americas contribute to changes in pathology. These results can inform experiments required to elucidate the role of viral genetic evolution in changes in neuropathology, including microcephaly and other neurological and skeletomuscular issues in infants, and Guillain-Barr e syndrome in adults.

Research paper thumbnail of Compounds and methods for enhancing delivery of free polynucleotide

Research paper thumbnail of ***Withdrawn Application as Per the Latest Uspto Withdrawn List***Expression of Exogenous Polynucleotide Sequences in a Vertebrate

Research paper thumbnail of Method for gene transfection and vaccination through skin using electropermeabilization

Research paper thumbnail of Process for Enhancing Electric Field-Mediated Delivery of Biological Materials Into Cells

Research paper thumbnail of Zika Fetal Neuropathogenesis: Etiology of a Viral Syndrome

The ongoing Zika Virus epidemic in the Americas, and the observed association with both fetal abn... more The ongoing Zika Virus epidemic in the Americas, and the observed association with both fetal abnormalities (primary microcephaly) and adult autoimmune pathology (Guillain-Barré syndrome) has brought attention to this neglected pathogen. While initial case studies generated significant interest in the Zika virus outbreak, larger prospective epidemiology and basic virology studies examining the mechanisms of Zika viral infection and associated pathophysiology are only now starting to be published. In this review, we analyze Zika fetal neuropathogenesis from a comparative pathology perspective, using the historic metaphor of “TORCH” viral pathogenesis to provide context. By drawing parallels to other viral infections of the fetus, we identify common themes and mechanisms that may illuminate the observed pathology. The existing data on the susceptibility of various cells to both Zika and other flavivirus infections are summarized. Finally, we highlight relevant aspects of the known mol...

Research paper thumbnail of Polyfunctional Cationic Cytofectins, Formulations and Methods for Generating Active Cytofectin:Polynucleotide Transfection Complexes

Research paper thumbnail of In vivo translation delivering antisense nucleotides; elicit-ing immune response to poorly immunogenic viral proteins

Research paper thumbnail of DNA vaccines for eliciting a mucosal immune response

Research paper thumbnail of Zika Virus Disease: A Simple Model Approach to Rapid Impact Assessment

There has been substantial media attention regarding Zika infection as a threat to pregnancy, pro... more There has been substantial media attention regarding Zika infection as a threat to pregnancy, prompted by WHOs declaration of a Public Health Event of International Concern (PHEIC). Here we present a simple risk assessment model for two states within the continental United States at-risk for autochthonous transmission of Zika virus, Texas and Florida. Our simple impact assessment model is partially validating at this early interval in the crisis.

Research paper thumbnail of Producing antibodies directed to protein of hiv virus in mice, dna plasmids

Research paper thumbnail of Lipid-mediated polynucleotide administration to deliver a biologically active peptide and to induce a cellular immune response

Research paper thumbnail of Methods of delivering a physiologically active polypeptide to a mammal

Research paper thumbnail of Generation of antibodies through lipid mediated DNA delivery

Research paper thumbnail of Biological injections into mamalian muscle of dna to express a therapeutic protein, polypeptide or peptide; vaccines; administering a dystrophin gene correcting muscular dystrophy

Research paper thumbnail of Generation of an immune response to a pathogen

Research paper thumbnail of Expression of exogenous polynucleotide sequences in a vertebrate

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