Ohtake S.,Aridis Pharmaceuticals, Llc |
Journal of Pharmaceutical Sciences | Year: 2011
Trehalose, a disaccharide of glucose, has been reported to accumulate in many organisms that can withstand extended periods of inanimation. Since this discovery, the properties of trehalose have been examined extensively to understand its role and abundance in nature. The unique features of this sugar became clearer with each new finding which demonstrated its ability to sustain and preserve a wide array of biological molecules. Trehalose has been used in a variety of research applications and is contained in several commercially available therapeutic products, including Herceptin®, Avastin®, Lucentis®, and Advate®. Currently, there is a growing interest in the use of trehalose in solid dosage formulations, most notably in quick-dissolving tablets. Furthermore, trehalose has found its use in several food and cosmetic products, and new applications capitalizing on its unique properties are being developed and implemented in everyday-use products. As trehalose is an approved ingredient in all major markets, there is no significant barrier to its use. Extensive work with trehalose has been conducted in the three major industries, however with little overlap. Further understanding of the role of trehalose in the various applications may lead to an increase in the number of trehalose-containing products. © 2011 Wiley-Liss, Inc.
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 2.92M | Year: 2011
DESCRIPTION (provided by applicant): Over the past two decades, the number of new antimicrobials being developed has experienced a greater than 60% decline, while the number of antibiotic resistant microorganisms has been steadily increasing. Only one newantibacterial drug with a novel mechanism of action (linezolid) has been introduced during this period making the long term outlook for sustained infection control increasingly precarious. One particularly concerning example is a Gram negative bacterium called Pseudomonas aeruginosa in which 30% of clinical isolates from ICU (intensive care unit) or nursing home patients were reported to be resistant to 3 or more drugs. The Infectious Diseases Society of America (IDSA) also identified P. aeruginosa as one of six superbugs on the top priority hit list of dangerous pathogens that are becoming increasingly drug resistant. P. aeruginosa poses a particularly deadly threat for lung infections in hospital acquired pneumonia (HAP), particularly ventilator associated pneumonia (VAP) cases and in cystic fibrosis (CF) patients. The major hypothesis to be tested in this application is whether a human monoclonal antibody (mAb) targeted against a prevalent cell surface carbohydrate (alginate) on P. aeruginosa can be used clinically to treat P. aeruginosa lung infections resulting in improvement in lung function and a reduction in morbidity and mortality. Preliminary data indicate that these human mAbs recognize an epitope on alginate that is expressed on a broad arrayof P. aeruginosa clinical isolates. The mAb kills these isolates through an immune mediated process called opsono-phagocytosis and can be used therapeutically to protect animals from lethal lung infections. In this application, we propose to scale-up themanufacturing process for the mAb and produce clinical material for future clinical trials. We propose to test the clinical material in toxicity studies in animals according to Good Laboratory Procedures (GLP) to demonstrate that the mAb is safe to administer to people in human clinical testing. Finally, we propose to schedule a pre-IND (investigational new drug) meeting with the FDA to present and discuss the Mab preclinical data and our proposed clinical plan. Incorporating feedback from the FDA, we willthen file an IND application. PUBLIC HEALTH RELEVANCE: The proposed studies will result in further development of a human monoclonal antibody for the treatment of severe bacterial lung infections due to Pseudomonas aeruginosa in patients with hospital acquired pneumonia and cystic fibrosis. Clinical material will be produced, safety data in animals will be generated and an IND will be filed with the FDA.
Aridis Pharmaceuticals, Llc | Date: 2010-05-04
A method and composition for treatment of bacterial infections caused by gram negative or gram positive bacteria such as Staphylococcus aureus, Rhodococcus equi, Mycobacterium tuberculosis, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, Serratia marcescens as well as those caused by Burkholderia cepacia, Stenotrophomonas maltophilia, Alcaligenes xylosoxidans, and multidrug resistant Pseudomonas aeruginosa, using a formulation containing gallium (III), in a pharmaceutically acceptable salt or complex thereof.
Aridis Pharmaceuticals, Llc | Date: 2010-11-18
A method for the selection of pharmaceutically acceptable excipients that allow for the production of highly dispersible powders produced by spray drying.
Aridis Pharmaceuticals, Llc | Date: 2012-11-29
The present invention provides antigenic polypeptides expressed during an infection by a pathogenic organism, such as Acinetobacter and compositions comprising these polypeptides. The invention further provides compositions for use in treating, preventing or detecting a bacterial infection, in particular vaccine compositions using the antigenic polypeptides. The invention further provides antibodies directed to said antigenic polypeptides.
Aridis Pharmaceuticals, Llc | Date: 2014-10-29
This invention is directed to an antibody construct or fragment thereof derived from an RSV-infected human, such that the antibody construct binds with specificity to RSV fusion protein antigenic region II/A with an affinity of greater than 110^(9 )M. Preferably, the antibody construct is capable of neutralizing RSV strains, including at least one RSV strain that is resistant to palivizumab. The invention further relates to nucleic acids encoding the antibody construct or portions thereof, and cell lines expressing the antibody. This invention further relates to methods for producing said antibody construct, and to the use of said antibody construct for treating or preventing infection of a patient by RSV having a normal or mutated version of F protein.
Aridis Pharmaceuticals, Llc | Date: 2015-04-15
The present invention relates to a human monoclonal antibody specific for the alpha-toxin of S. aureus and a hybridoma producing said monoclonal antibody. In addition, the present invention relates to pharmaceutical compositions comprising at least one antibody or at least one nucleic acid encoding said antibody. Further, the present inventions relates to the use of said monoclonal antibody for treating or preventing abscess formation.
Aridis Pharmaceuticals, Llc | Date: 2015-06-01
Biochemicals, namely, monoclonal antibodies for in vitro scientific or research use; Laboratory chemicals, namely, an antibody reagent used for the detection of antigens in cell and tissue analysis for in vitro diagnostic use. Diagnostic kits consisting primarily of monoclonal antibodies, buffers, and reagents for use in disease testing; Medicinal preparations for the treatment of infectious diseases and for use in oncology; Pharmaceutical preparations for the treatment and prevention of pneumonia, cystic fibrosis, eye infection, bronchitis, bronchiectasis, urinary tract infections, COPD, bloodstream infection, skin infections, surgical related infections, endocarditis; Pharmaceutical products for the treatment of viral and infectious diseases, for the treatment of cancer. Biochemical research and development; Medical and scientific research in the field of infectious diseases; Pharmaceutical research and development.
Aridis Pharmaceuticals, Llc | Date: 2012-08-14
This invention provides methods of spray drying pharmaceutical powders from a vibrating nozzle at low pressures. The method can effectively spray dry thick or viscous solutions or suspensions to provide small uniform particles. The invention includes dry particle compositions prepared by methods of low pressure spraying from vibrating nozzles.