ALACHUA, FL, United States
ALACHUA, FL, United States
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Patent
Nanotherapeutics, Inc. | Date: 2017-01-26

Described herein are compositions comprising particles of poorly soluble drugs encapsulated by stabilizers. Further described are pharmaceutical compositions comprising such encapsulated compositions. Also described are methods of making such encapsulated particle compositions, and methods of making the corresponding pharmaceutical compositions. The encapsulated particle compositions described herein allow poorly soluble drugs to be administered with good bioavailability by routes that are non-invasive to patients, such as by oral administration.


The instant disclosure provides O-acetylated high molecular weight polygalacturonic acids or pharmaceutically acceptable salts thereof, having at least one of: (a) a molecular weight greater than 1 x 106 Da; (b) a degree of methylation less than about 10% per mole; and (c) an intervening rhamnose content ranging from about 2% to about 15% per mole, useful as a synthetic immunogenic Vi antigen. The instant disclosure further provides methods of preparing an O-acetylated high molecular weight polygalacturonic acid or pharmaceutically acceptable salt thereof of, pharmaceutical compositions and/or vaccine compositions comprising the same, and methods of immunization using any of the foregoing.


Patent
Nanotherapeutics, Inc. | Date: 2015-04-16

The present disclosure relates generally to methods of treatment of Clostridium difficile-associated disorders and/or C. difficile spores in the gastrointestinal tract by administering ramoplanin or a pharmaceutical formulation thereof, pharmaceutical compositions comprising ramoplanin, and therapeutic uses thereof in treating Clostridium difficile-associated disorders and/or C. difficile spores.


The present invention relates to recombinant viral vectors and methods of using the recombinant viral vectors to induce an immune response to influenza A viruses. The invention provides recombinant viral vectors based, for example, on the non-replicating modified vaccinia virus Ankara. When administered according to methods of the invention, the recombinant viral vectors are designed to be cross-protective and induce heterosubtypic immunity to influenza A viruses.


Patent
Nanotherapeutics, Inc. | Date: 2016-07-11

The present invention relates to a method for production of continuous cell lines comprising providing living cells of an animal or a human, irradiating said cells with UV light, proliferating said cells and selecting multiplying cells as cells of a continuous cell line.


The present disclosure provides compositions comprising particles, the particles comprising 3-aminopyridine-2-carboxaldehyde (3-AP) and at least one controlled-release polymer, wherein the 3-AP is encapsulated by the at least one controlled-release polymer, and pharmaceutical compositions comprising such compositions. The present disclosure also provides methods of treatment by administering an effective amount of the compositions or pharmaceutical compositions of the present disclosure, methods of making such encapsulated particle compositions, and methods of making the corresponding compositions and pharmaceutical compositions.


Patent
Nanotherapeutics, Inc. | Date: 2013-01-15

Described herein are compositions comprising particles of poorly soluble drugs encapsulated by stabilizers. Further described are pharmaceutical compositions comprising such encapsulated compositions. Also described are methods of making such encapsulated particle compositions, and methods of making the corresponding pharmaceutical compositions. The encapsulated particle compositions described herein allow poorly soluble drugs to be administered with good bioavailability by routes that are non-invasive to patients, such as by oral administration.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 2.99M | Year: 2013

DESCRIPTION provided by applicant Noroviruses are a group of enteropathogenic viruses belonging to the taxonomic family Caliciviridae which causes approximately of epidemic non bacterial outbreaks of gastroenteritis around the world and may be responsible for of all foodborne outbreaks of gastroenteritis in the US In developing countries according to a estimate by CDC researchers up to children less than years old die of norovirus infection each year There is no vaccine against norovirus and no specific antiviral drugs to treat infections To be safe and effective a vaccine must protect humans against two serotypes of Norovirus currently causing epidemics Nanotherapeutics and its collaborators propose to conduct BLA enabling preclinical development of a stable dry powder nasal norovirus vaccine that will form the basis for initiation of Phase I clinical studies The vaccine consists of the GelVacandquot dry powder formulation in combination with recombinant virus like particle rVLP antigens of two dominant norovirus genotypes G III manufactured in green plants using a transient viral expression system The powder vaccine is packaged in an established disposable nasal powder inhaler Valois Monopowder MK IV ready for nasal administration The GelVacandquot dry powder formulation is a novel in situ gelling nasal powder vaccine delivery platform based on GelSite R polymer a distinct and inert ionic polysaccharide polygalacturonic acid that enhances the immune response through prolonged nasal residence sustained antigen release by an in situ gelation mechanism and stabilization of vaccine antigens The GelVacandquot dry powder approach addresses the storage and administration shortcomings of the current NoV oral approach The G I VLP antigen produced using the plant expression system has been successfully formulated with GelVacandquot dry powder and a series of preclinical immunogenicty studies have been conducted with the vaccine formulation at Arizona State Universityandapos s ASU These studies have demonstrated that the antigen is stable in the GelVacandquot dry powder and nasal administration of the GelVacandquot dry powder with G I antigen induced strong mucosal and humroal responses including a robust IgA response in intestinal tract In addition the response levels generated with GelVacandquot dry powder was comparable or better than those with formulations containing a variety of TLR agonists as adjuvants These studies formed a solid basis for the proposed fast track development of GelVacandquot dry powder NoV vaccine containing both G I and G II antigens that is designed to provide protection against two dominant norovirus genotypes Noroviruses are a group of enteropathogenic viruses belonging to the taxonomic family Caliciviridae which causes approximately of epidemic non bacterial outbreaks of gastroenteritis around the world and may be responsible for of all foodborne outbreaks of gastroenteritis in the US The GelVacandquot dry powder formulation is a novel in situ gelling nasal powder vaccine delivery platform based on GelSite R polymer a distinct and inert ionic polysaccharide polygalacturonic acid that enhances the immune response through prolonged nasal residence sustained antigen release by an in situ gelation mechanism and stabilization of vaccine antigens These studies formed a solid basis for the proposed fast track development of GelVacandquot dry powder NoV vaccine containing both G I and G II antigens that is designed to provide protection against two dominant norovirus genotypes


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 578.71K | Year: 2011

DESCRIPTION (provided by applicant): Noroviruses are a group of enteropathogenic viruses belonging to the taxonomic family Caliciviridae, which causes approximately 90% of epidemic non-bacterial outbreaks of gastroenteritis around the world and may be responsible for 50% of all foodborne outbreaks of gastroenteritis in the US. In developing countries, according to a 2008 estimate by CDC researchers, up to 200,000 children less than 5 years old die of norovirus infection each year. There is no vaccine against norovirus and no specific antiviral drugs to treat infections. To be safe and effective a vaccine must protect humans against two serotypes of Norovirus currently causing epidemics. Nanotherapeutics and its collaborators propose to conduct BLA-enabling preclinical development of a stable, dry-powder nasal norovirus vaccine that will form the basis for initiation of Phase I clinical studies. The vaccine consists of the GelVac dry powder formulation in combination with recombinant virus-like particle (rVLP) antigens of two dominant norovirus genotypes (G-III) manufactured in green plants using a transient viral expression system. The powder vaccine is packaged in an established disposable nasal powder inhaler (Valois Monopowder MK IV) ready for nasal administration. The GelVac dry-powder formulation is a novel in situ gelling nasal powder vaccine delivery platform based on GelSite(R) polymer, a distinct and inert ionic polysaccharide (polygalacturonic acid) that enhances the immune response through (1) prolonged nasal residence, (2) sustained antigen release by an in situ gelation mechanism, and (3) stabilization of vaccine antigens. The GelVac dry powder approach addresses the storage and administration shortcomings of the current NoV oral approach. The G-I VLP antigen produced using the plant expression system has been successfully formulated with GelVac dry powder and a series of preclinical immunogenicty studies have been conducted with the vaccine formulation at Arizona State University's (ASU). Thesestudies have demonstrated that the antigen is stable in the GelVac dry powder and nasal administration of the GelVac dry powder with G-I antigen induced strong mucosal and humroal responses, including a robust IgA response in intestinal tract. In addition, the response levels generated with GelVac dry powder was comparable or better than those with formulations containing a variety of TLR agonists as adjuvants. These studies formed a solid basis for the proposed fast-track development of GelVac dry powder NoV vaccine containing both G-I and G-II antigens that is designed to provide protection against two dominant norovirus genotypes. PUBLIC HEALTH RELEVANCE: Noroviruses are a group of enteropathogenic viruses belonging to the taxonomic family Caliciviridae, which causes approximately 90% of epidemic non-bacterial outbreaks of gastroenteritis around the world and may be responsible for 50% of all foodborne outbreaks of gastroenteritis in the US. The GelVac dry-powder formulation is a novel in situgelling nasal powder vaccine delivery platform based on GelSite(R) polymer, a distinct and inert ionic polysaccharide (polygalacturonic acid) that enhances the immune response through (1) prolonged nasal residence, (2) sustained antigen release by an in situ gelation mechanism, and (3) stabilization of vaccine antigens. These studies formed a solid basis for the proposed fast-track development of GelVac dry powder NoV vaccine containing both G-I and G-II antigens that is designed to provide protection against two dominant norovirus genotypes.


Patent
Nanotherapeutics, Inc. | Date: 2016-09-07

Described herein are compositions comprising particles of poorly soluble drugs, in particular opiods, encapsulated by stabilizers, in particular polyethylene glycol (PEG). Further described are pharmaceutical compositions comprising such encapsulated compositions. Also described are methods of making such encapsulated particle compositions, and methods of making the corresponding pharmaceutical compositions. The encapsulated particle compositions described herein allow poorly soluble drugs to be administered with good bioavailability by routes that are non-invasive to patients, such as by oral administration.

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