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ALACHUA, FL, United States

The US Food and Drug Administration (FDA) requires risk communication as an element of Risk Evaluation and Mitigation Strategies (REMS) to alert and educate healthcare providers about severe toxicities associated with approved drugs. The educational effectiveness of this approach has not been evaluated. To support the communication plan element of the ipilimumab REMS, a Medscape Safe Use Alert (SUA) letter was distributed by Medscape via email and mobile device distribution to clinicians specified in the REMS. This alert contained the FDA-approved Dear Healthcare Provider (DHCP) letter mandated for distribution. A continuing medical education (CME) activity describing ipilimumab toxicities and the appropriate management was simultaneously posted on the website and distributed to Medscape members. Data were collected over a 6-month period regarding the handling of the letter and the responses to pre- and post-test questions for those who participated in the CME activity. Analysis of the answers to the pre- and posttest questions showed that participation in the CME activity resulted in an improvement in correct answer responses of 47%. Our experience shows that there are likely distinct information sources that are utilized by different HCP groups. The ready availability of a brief CME activity was utilized by 24,063 individuals, the majority of whom showed enhanced understanding of ipilimumab toxicity by improvement in post-test scores, educational data that are not available via implementation of standard safety alert communications. These results demonstrate that improvement in understanding of specific drug toxicities is enhanced by a CME intervention. Source


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 Defense | Branch: Navy | Program: SBIR | Phase: Phase II | Award Amount: 940.88K | Year: 2006

The overall goal of this Phase II project is to develop the Nanobreath® detection system for proximity detection of explosives at 50 meters, and specifically detection of peroxide improvised explosive devices (IED’s) such as TATP and HMTD. Pentagon statistics show that about half the U.S. battle deaths occurred as a result of homemade, easy-to-hide IED’s. Proximity vapor sampling and detection is non-invasive and allows wide area detection from stationary or moving air sampling. In the Phase I SBIR project, Nanotherapeutics, Inc. was successful in demonstrating proximity detection of triacetone triperoxide (TATP) peroxide explosive using its proprietary Nanobreath® preconcentrator and 4-SAW array. The current Nanobreath® setup was successfully able to provide sensitive and vapor specific detection proportional to a 100 gram TATP IED 5 to 10 meters away and Phase II studies are proposed to improve the sensitivity and specificity resulting in a device that can provide rapid detection of concealed explosives at safe distances (50 meters). The Phase II project will include development and testing of a robust, commercializable detection system (System modification, IED agent vapor quantification, IED agent challenge, laboratory interference tests, and field interference tests) in collaboration with its commercialization partner RF Monolithics, Inc.


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: 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.

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