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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.


News Article | November 9, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for Rotavirus Infections  ,complete with analysis by stage of development,drug target,mechanism of action (MoA),route of administration (RoA) and molecule type. The report also coversthe descriptive pharmacological action of the therapeutics,its complete research and development history and latest news and press releases. Additionally,the report provides an overview of key players involved in therapeutic development for Rotavirus Infections   and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios,enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Rotavirus Infections - Pipeline Review,H2 2016 addition with 26 market data tables and 13 figures, spread across 62 pages is available at http://www.rnrmarketresearch.com/rotavirus-infections-pipeline-review-h2-2016-market-report.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct's proprietary databases,company/university websites,clinical trial registries,conferences,SEC filings,investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally,various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Beijing Minhai Biotechnology Co., Ltd,Bharat Biotech International Limited,Biological E. Limited,Curevac AG ,Medicago Inc. ,MSD Wellcome Trust Hilleman Laboratories Pvt Ltd,Nanotherapeutics, Inc.,Serum Institute of India Limited,Shantha Biotechnics Limited,Sinovac Biotech Ltd.,Takeda Pharmaceutical Company Limited,Wuhan Institute of Biological Products Co., Ltd. Inquire before buying http://www.rnrmarketresearch.com/contacts/inquire-before-buying?rname=748014(This is a premium report price at US$2000 for a single user PDF license).


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.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 595.95K | Year: 2010

DESCRIPTION (provided by applicant) Typhoid fever is a major cause of morbidity worldwide with an estimated incidence of 16 to 33 million infections and 500,000 to 600,000 deaths annually. It is caused by Salmonella typhi (S. typhi). The Vi capsular polysaccharide of S. typhi is the protective antigen and is used in current licensed Vi vaccines for prophylactic immunization against typhoid fever for people of e 2 years. The current licensed Vi vaccines are produced by costly and hazardous fermentation of S. typhi wild type bacteria and elaborate purification processes. A second generation of typhoid vaccines based on Vi polysaccharide-protein conjugate is being developed that may potentially be more immunogenic and effective in children under 2 years. A high-molecular-weight PGA (HPGA) from a plant source has been developed and is manufactured by Nanotherapeutics under cGMP at a kilogram (kg) scale. The end product also had a high molecular weight (gt2 x 106 Da) similar to that of the native Vi polysaccharide. The O-acetylated HPGA (OAcHPGA) not only shared the same antigenicity with the Vi polysaccharide, but was also immunogenic in laboratory animals. The antibody response level induced by OAcHPGA was comparable to that of a marketed Vi vaccine. These studies indicate that this OAcHPGA could potentially be used to make a synthetic typhoid vaccine that can be produced in large quantities from a plant-based starting material (HPGA). Compared to the existing Vi polysaccharide vaccine, OAcHPGA could be a much safer and less expensive vaccine. The economic advantage makes it easier and more affordable to expand production and use of the typhoid vaccine worldwide, especially in endemic areas of developing countries. Thus, we propose to continue developing a synthetic typhoid vaccine based on OAcHPGA with the following two specific aims: (Specific Aim 1 - Immunogenicity and protection studies) To evaluate the immunogenicity of OAcHPGA based on the potency indicators (DOAc and molecular weight) and to demonstrate the protective effect of the OAcHPGA against the S. typhi challenge in animal models. This will establish that the OAcHPGA is immunogenic and protective against the S. typhi, and help establish product specifications in the future. (Specific Aim 2 - Process development) To refine and establish the O-acetylation process for producing OAcHPGA with desired DOAc, molecular weight, and other properties. This will be conducted together with related assay development and in conjunction with Specific Aim 1. In addition, the OAcHPGA-protein conjugate will be prepared and evaluated. Accomplishment of these two specific aims will form the base for next development phases toward pilot cGMP manufacturing, animal toxicology studies, and clinical studies of the OAcHPGA vaccine and, also importantly, the development of an OAcHPGA-protein conjugate vaccine that may potentially be more immunogenic and suitable for children under the age of 2. PUBLIC HEALTH RELEVANCE: Typhoid fever is a major cause of morbidity worldwide with an estimated incidence of 16 to 33 million infections and 500,000 to 600,000 deaths annually. The current licensed Vi vaccines are produced by costly and hazardous fermentation of S. typhi wild type bacteria and elaborate purification processes. A second generation of typhoid vaccines based on Vi polysaccharide-protein conjugate is being developed that may potentially be more immunogenic and effective in children under 2 years.


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.


News Article | December 1, 2016
Site: www.businesswire.com

ALACHUA, Fla.--(BUSINESS WIRE)--Nanotherapeutics, Inc., a contract development and manufacturing organization (CDMO), announced today that Prasad Raje, Ph.D., has been appointed President and Chief Executive Officer, succeeding James M. Matthew, who served as interim President and Chief Executive Officer and will retain his position as Chief Financial Officer. Dr. Raje’s expertise in the CDMO space is expected to be a driving factor as Nanotherapeutics establishes its footprint in the commercia

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