A method of reducing the incidence of mucocutaneous ulcers or vasculitis in an individual comprising administering an effective amount of dusquetide in a formulation, wherein the formulation comprises no excipients. More specifically, a method of treating oral, genital or cutaneous aphthous lesions in an individual by administering an effective amount of excipient-free dusquetide, wherein the individual has been diagnosed with Behçet's disease.
A61P 1/04 - Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
2.
COMPOSITIONS AND METHODS OF TREATMENT OF CERTAIN VASCULITIS SYNDROMES
A method of reducing the incidence of mucocutaneous ulcers or vasculitis in an individual comprising administering an effective amount of dusquetide in a formulation, wherein the formulation comprises no excipients. More specifically, a method of treating oral, genital or cutaneous aphthous lesions in an individual by administering an effective amount of excipient-free dusquetide, wherein the individual has been diagnosed with Behqet's disease.
A61P 1/04 - Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
A61P 29/00 - Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agentsNon-steroidal antiinflammatory drugs [NSAID]
A61P 43/00 - Drugs for specific purposes, not provided for in groups
3.
Telmisartan Nanosuspension for Therapy of Respiratory Infections and Methods of Making and Using Same
A method of inhibiting viral replication of a virus in an individual comprising administering an effective amount of a drug nanosuspension combined with a surfactant, wherein the drug nanosuspension combined with the surfactant is delivered to the individual's lungs. Preferably, the drug is a nanosuspension delivered to the individual's lungs through inhalation.
Disclosed is a stable immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one antigen consisting of a filovirus glycoprotein and at least one nano-emulsion adjuvant which are co-lyophilized and can be reconstituted immediately prior to use. Also disclosed is a vaccine composition comprising at least two antigens, wherein each antigen is specific to a different genus of filovirus and which also comprises at least one nano-emulsion adjuvant.
Recombinant vaccine compositions combined with a specified adjuvant to deliver a robust immune response against coronaviruses for inducing protective immunity to a coronavirus comprising providing a stable immunogenic composition capable of eliciting a robust and durable immune response to the coronavirus, wherein the composition comprises a protein subunit comprising a recombinant protein specific to the coronavirus and at least one adjuvant.
A method of inhibiting viral replication of a virus in an individual comprising administering an effective amount of a drug nanosuspension combined with a surfactant, wherein the drug nanosuspension combined with the surfactant is delivered to the individual's lungs. Preferably, the drug is a nanosuspension delivered to the individual's lungs through inhalation.
Disclosed is a stable immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one antigen consisting of a filovirus glycoprotein and at least one nano-emulsion adjuvant which are co-lyophilized and can be reconstituted immediately prior to use. Also disclosed is a vaccine composition comprising at least two antigens, wherein each antigen is specific to a different genus of filovirus and which also comprises at least one nano-emulsion adjuvant.
A method of treating CTCL comprising applying a combination of an effective amount of hypericin together with a form of visible light photodynamic therapy. Preferably, the effective amount of hypericin is an ointment comprising less than 1% hypericin. More preferably, the form of photodynamic therapy comprises an administration of escalating doses of visible light. Optionally, the escalating doses of visible light starts at about 5 J/cm2and increases to a maximum dose of about 12 J/cm2.
Recombinant vaccine compositions combined with a specified adjuvant to deliver a robust immune response against coronaviruses for inducing protective immunity to a coronavirus comprising providing a stable immunogenic composition capable of eliciting a robust and durable immune response to the coronavirus, wherein the composition comprises a protein subunit comprising a recombinant protein specific to the coronavirus and at least one adjuvant.
The Regents of the University of Colorado, a body corporate (USA)
Soligenix, Inc. (USA)
Inventor
Hassett, Kimberly
Nandi, Pradyot
Brey, Robert N.
Carpenter, John
Randolph, Theodore
Abstract
Compositions relating to thermostable vaccines and methods of preparing the same. Specifically, methods of preparing thermostable vaccines based on a recombinant ricin neurotoxin protein and uses of co-adjuvants to develop a composition capable of eliciting an immune response in a subject.
Disclosed is a stable immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one antigen consisting of a filovirus glycoprotein and at least one nano-emulsion adjuvant which are co-lyophilized and can be reconstituted immediately prior to use. Also disclosed is a vaccine composition comprising at least two antigens, wherein each antigen is specific to a different genus of filovirus and which also comprises at least one nano-emulsion adjuvant.
Disclosed is a stable immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one antigen consisting of a filovirus glycoprotein and at least one nano-emulsion adjuvant which are co-lyophilized and can be reconstituted immediately prior to use. Also disclosed is a vaccine composition comprising at least two antigens, wherein each antigen is specific to a different genus of filovirus and which also comprises at least one nano-emulsion adjuvant.
Improved systems and methods for producing synthetic hypericin at high volume and high purity. In particular, systems and methods of preparing a purified synthetic hypericin resulting from irradiation, wherein the irradiation step is performed in a continuous flow micro-reactor. The process of manufacturing purified synthetic hypericin results in the synthetic yield of 30-100% of the dry product.
Preclinical data obtained in models of chemotherapy-induced mucositis, radiation-induced mucositis, neutropenic infection and colitis indicate oral mucositis is a promising indication for Innate Defense Regulator (IDR) peptides. Preclinical efficacy results obtained with IDRs in mouse and hamster models of mucositis indicate that dosing every third day should be able to cover the mucositis “window” with seven to fourteen doses, depending on the duration of chemotherapy or radiation exposure. IDRs have also shown efficacy in mouse models of chemotherapy-induced oral and gastrointestinal mucositis, consistent with the response of the innate immune response to chemotherapy and/or radiation damage. IDRs are also effective at reducing bacterial burden and improve survival in the presence or absence of antibiotic treatment in various murine infection models.
C07K 9/00 - Peptides having up to 20 amino acids, containing saccharide radicals and having a fully defined sequenceDerivatives thereof
C07K 7/06 - Linear peptides containing only normal peptide links having 5 to 11 amino acids
C07K 5/11 - Tetrapeptides the side chain of the first amino acid containing more amino groups than carboxyl groups, or derivatives thereof, e.g. Lys, Arg
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
Stable immunogenic composition capable of eliciting a robust and durable immune response yielding a measurable increase in neutralizing antibodies at least 200 days post-administration, comprising at least one antigen consisting of a ribosome inactivating protein and at least one antigen comprising a toxin derived from bacterial spores. Method making and using a stable immunogenic composition capable of eliciting a stable immune response yielding a measurable increase in neutralizing antibodies at least 200 days post-administration, comprising providing an immunogenic composition comprising at least one antigen comprising a ribosome inactivating protein and at least one antigen comprising a toxin derived from bacterial spores and administering the immunogenic composition to an individual.
C07C 50/36 - Quinones containing groups having oxygen atoms singly bound to carbon atoms the quinoid structure being part of a condensed ring system having four or more rings
C07C 50/36 - Quinones containing groups having oxygen atoms singly bound to carbon atoms the quinoid structure being part of a condensed ring system having four or more rings
C07C 46/10 - SeparationPurificationStabilisationUse of additives
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Vaccine preparations; vaccines; human vaccine preparations. Research, development, engineering and testing services in
the fields of immunopharmaceuticals and vaccines.
22.
Peptides and analogs for use in the treatment of oral mucositis
Preclinical data obtained in models of chemotherapy-induced mucositis, radiation-induced mucositis, neutropenic infection and colitis indicate oral mucositis is a promising indication for Innate Defense Regulator (IDR) peptides. Preclinical efficacy results obtained with IDRs in mouse and hamster models of mucositis indicate that dosing every third day should be able to cover the mucositis “window” with seven to fourteen doses, depending on the duration of chemotherapy or radiation exposure. IDRs have also shown efficacy in mouse models of chemotherapy-induced oral and gastrointestinal mucositis, consistent with the response of the innate immune response to chemotherapy and/or radiation damage. IDRs are also effective at reducing bacterial burden and improve survival in the presence or absence of antibiotic treatment in various murine infection models.
C07K 7/06 - Linear peptides containing only normal peptide links having 5 to 11 amino acids
C07K 5/11 - Tetrapeptides the side chain of the first amino acid containing more amino groups than carboxyl groups, or derivatives thereof, e.g. Lys, Arg
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
The present invention features methods of delivering corticosteroids or metabolites thereof for treating inflammatory conditions otherwise difficult to cure with topical administration.
A61K 31/00 - Medicinal preparations containing organic active ingredients
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 9/00 - Medicinal preparations characterised by special physical form
Stable immunogenic composition capable of eliciting a robust and durable immune response yielding a measurable increase in neutralizing antibodies at least 200 days post-administration, comprising at least one antigen consisting of a ribosome inactivating protein and at least one antigen comprising a toxin derived from bacterial spores. Method making and using a stable immunogenic composition capable of eliciting a stable immune response yielding a measurable increase in neutralizing antibodies at least 200 days post-administration, comprising providing an immunogenic composition comprising at least one antigen comprising a ribosome inactivating protein and at least one antigen comprising a toxin derived from bacterial spores and administering the immunogenic composition to an individual.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Vaccine preparations, namely, vaccines against the Ricin toxin; Vaccines, namely, vaccines against the Ricin toxin; Human vaccine preparations, namely, vaccine preparations against the Ricin toxin
26.
NOVEL PEPTIDES AND ANALOGS FOR USE IN THE TREATMENT OF MACROPHAGE ACTIVATION SYNDROME
Innate Defense Regulators (IDRs) interact with intracellular signaling events and modulate the innate defense response. Whereas much of the initial work with the IDRs focused on their role in fighting infection, recent results in animal models of chemotherapy- or radiation-induced mucositis and wound healing suggest that IDRs can be beneficial during the responses to a broader range of damage-inducing agents beyond pathogens. RIVPA (SEQ ID NO. 5), has demonstrated safety in humans and efficacy in animal models of fractionated radiation-induced and chemotherapy-induced oral mucositis, in models of chemotherapy induced damage to the gastro-intestinal tract and in models of local and systemic Gram-positive and Gram-negative infection in immunocompetent and immunocompromised hosts. Based on this information, we propose the use of RIVPA (SEQ ID NO. 5) and / or other IDRs (Table 1) as a novel treatment for Macrophage Activation Syndrome.
Preclinical data obtained in models of chemotherapy-induced mucositis, radiation-induced mucositis, neutropenic infection and coiitis indicate oral mucositis is a promising indication for Innate Defense Regulator (IDR) peptides. Preclinical efficacy results obtained with IDRs in mouse and hamster models of mucositis indicate that dosing every third day should be able to cover the mucositis "window" with seven to fourteen doses, depending on the duration of chemotherapy or radiation exposure. IDRs have also shown efficacy in mouse models of chemotherapy-induced oral and gastrointestinal mucositis, consistent with the response of the innate immune response to chemotherapy and / or radiation damage. IDRs are also effective at reducing bacterial burden and improve survival in the presence or absence of antibiotic treatment in various murine infection models.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Vaccine preparations; vaccines. Research and development of vaccines and medicines;
research, development, engineering and testing services in
the fields of immunopharmaceuticals and vaccines.
29.
Peptides for treating and preventing immune-related disorders, including treating and preventing infection by modulating innate immunity
In one aspect, the present invention provides isolated novel peptides that can be used to modulate innate immunity in a subject and/or for the treatment of an immune-related disorder, including treating and preventing infection by modulating innate immunity. Also provided are an agent reactive with the peptide, a pharmaceutical composition that includes the peptide, an isolated nucleic acid molecule encoding the peptide, a recombinant nucleic acid construct that includes the nucleic acid molecule, at least one host cell comprising the recombinant nucleic acid construct, and a method of producing the peptide using the host cell. The present invention further provides a method for treating and/or preventing infection in a subject by administering the peptide of the invention to the subject, thereby modulating innate immunity in the subject. Additionally, the present invention provides a method for predicting whether a subject would be responsive to treatment with a peptide of the invention.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Vaccine preparations, namely human vaccines. (1) Research and development of human vaccines and medicines; Research, development, engineering and testing services in the fields of immunopharmaceuticals and human vaccines.
31.
Peptides for treating and preventing immune-related disorders, including treating and preventing infection by modulating innate immunity
In one aspect, the present invention provides isolated novel peptides that can be used to modulate innate immunity in a subject and/or for the treatment of an immune-related disorder, including treating and preventing infection by modulating innate immunity. Also provided are an agent reactive with the peptide, a pharmaceutical composition that includes the peptide, an isolated nucleic acid molecule encoding the peptide, a recombinant nucleic acid construct that includes the nucleic acid molecule, at least one host cell comprising the recombinant nucleic acid construct, and a method of producing the peptide using the host cell. The present invention further provides a method for treating and/or preventing infection in a subject by administering the peptide of the invention to the subject, thereby modulating innate immunity in the subject. Additionally, the present invention provides a method for predicting whether a subject would be responsive to treatment with a peptide of the invention.
C07K 7/06 - Linear peptides containing only normal peptide links having 5 to 11 amino acids
C07K 7/64 - Cyclic peptides containing only normal peptide links
C07K 7/00 - Peptides having 5 to 20 amino acids in a fully defined sequenceDerivatives thereof
C07K 7/08 - Linear peptides containing only normal peptide links having 12 to 20 amino acids
C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
C07K 7/54 - Cyclic peptides containing at least one abnormal peptide link with at least one abnormal peptide link in the ring
Results from two randomized trials have shown that oral beclomethasone dipropionate (BDP) is effective for treatment of acute gastrointestinal graft-versus-host disease (GVHD). Here, we report results of a double-blind, randomized placebo-controlled phase II study designed to test the hypothesis that acute GVHD could be prevented by administration of oral BDP, beginning before hematopoietic cell transplantation (HCT) and continuing until day 75 after HCT. Study drug (BDP or placebo) was administered as 1 mg immediate-release formulation plus 1 mg delayed-release formulation orally four times daily. According to the primary endpoint, systemic glucocorticoid treatment for GVHD was given to 60 of the 92 participants (65%) in the BDP arm, versus 31 of 46 participants (67%) in the placebo arm. The secondary efficacy endpoints showed no statistically significant differences between the two arms.
A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A61P 1/00 - Drugs for disorders of the alimentary tract or the digestive system
42 - Scientific, technological and industrial services, research and design
Goods & Services
Research and development of vaccines and medicines; Research, development, engineering and testing services in the fields of immunopharmaceuticals and vaccines
35.
THERMOSTABLE VACCINE COMPOSITIONS AND METHODS OF PREPARING SAME
The disclosure provides compositions relating to thermostable vaccines and methods of preparing same. Specifically, the disclosure provides for methods of preparing thermostable vaccines based on a recombinant ricin neurotoxin protein and uses of co-adjuvants to develop a composition capable of eliciting an immune response in a subject.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Vaccine preparations; vaccines. Research and development of vaccines and medicines;
research, development, engineering and testing services in
the fields of immunopharmaceuticals and vaccines.
The present invention provides a method for making hypericin comprising the steps of converting a protohypericin to a protohypericin salt, and irradiating the protohypericin salt with visible light to form hypericin. The present invention also provides an apparatus comprising a transparent column having a top end and a bottom end, an inlet attached to the column at the top end to flow reactants into the column, a container attached to the column at the bottom end; and a visible light source positioned to cast light on to the column. The present invention further provides a method for making hypericin using said apparatus.
C07C 45/61 - Preparation of compounds having C=O groups bound only to carbon or hydrogen atomsPreparation of chelates of such compounds by reactions not involving the formation of C=O groups
C07C 45/81 - SeparationPurificationStabilisationUse of additives by change in the physical state, e.g. crystallisation
42 - Scientific, technological and industrial services, research and design
Goods & Services
Research and development of vaccines and medicines; Research, development, engineering and testing services in the fields of immunopharmaceuticals and vaccines
40.
TOPICALLY ACTIVE STEROIDS FOR USE IN RADIATION AND CHEMOTHERAPEUTICS INJURY
The present invention features methods of delivering corticosteroids or metabolites thereof for treating and preventing tissue damage resulting from acute radiation injury in the gastrointestinal tract with locally effective therapeutic agents.
A01N 37/00 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
A61K 31/21 - Esters, e.g. nitroglycerine, selenocyanates
In one aspect, the present invention provides isolated novel peptides that can be used to modulate innate immunity in a subject, and/or for the treatment of an immune-related disorder, including treating and preventing infection by modulating innate immunity. Also provided are an agent reactive with this peptide, a pharmaceutical composition that includes the peptide, an isolated nucleic acid molecule encoding the peptide, a recombinant nucleic acid construct that includes the nucleic acid molecule, at least one host cell comprising the recombinant nucleic acid construct, and a method of producing the peptide using the host cell. The present invention further provides a method for treating and/or preventing infection in a subject by administering the peptide of the invention to the subject, thereby modulating innate immunity in the subject. Additionally, the present invention provides a method for predicting whether a subject would be responsive to treatment with a peptide of the invention.
The invention relates to compositions and methods for drug delivery suitable for promoting the transmucosal absorption of drugs, especially drugs with poor intrinsic bioavailability, such as peptides, proteins, vaccines, and nucleic acids. The delivery system of this invention preferably comprises fatty acid esters and their hydrophilic derivatives that associate with water and other polar solvents to form reverse micelles that are physically stabilized in the presence of gastrointestinal fluid, water, and other hydrophilic solvents. Such stable reverse micelles are formed by suitable mixtures of polymeric or non-polymeric compounds with amphiphiles. Micelles made using these methods undergo phase transformation more slowly resulting in delayed drug release profiles and sustained absorption. When administered as a pharmaceutical to mucosal surfaces following oral ingestion or intranasal administration, therapeutic molecules principally solubilized in the aqueous phase are protected from digestion by mucosal enzymes and other mucosal degradative processes and are taken up by absorptive cell mechanisms and reach appropriate body compartments. The reverse micelle compositions may comprise mono-, di-glycerides and/or their transesterified products containing C6-C12 fatty acids chains, wherein the transester groups consist of hydrophilic moieties.
