Therabron Therapeutics, Inc.

Apc Research Assets, LLC

Clarassance, Inc.

Proteinix Company

Wellstat Biocatalysis, LLC

Claragen, Inc.

Claragen, Inc. and U.S. Government

Aprile L Pilon

Melissa E Winn

John H Kenten

Steven F Roberts

John K Zehmer

Alfonso Tramontano

Gerald L Lohnas

Pierre Borgeat

Richard S Clayton

Anil Baran Mukherjee

Humcha K Hariprakasha

Zhongjian Zhang

Richard William Welch

Louis Flamand

Pierre Ph D Borgeat

Louis Ph D Flamand

Methods of synthetically producing, formulating and using secretoglobins SCGB1A1, SCGB3A2, and SCGB3A1 are provided. Methods of using secretoglobins SCGB1A1, SCGB3A2, and SCGB3A1 as therapeutic agents to affect long term patient outcomes, such as preventing severe respiratory exacerbations of underlying conditions that require medical intervention, including hospitalization are provided. Methods of producing recombinant human secretoglobins, analytical methods, pharmaceutical compositions, and methods of use to prevent the long term sequelae of acute and chronic respiratory conditions are provided.

Compositions and methods of use for recombinant human secretoglobins

Novel compositions of recombinant human CC10 protein have been generated by chemically modifying the pure protein in vitro. Several new synthetic preparations containing isoforms of chemically modified CC10 have been generated by processes that utilize reactive oxygen species and reactive nitrogen species. These preparations contain novel isoforms of CC10 which have been characterized with enhanced or altered biological properties compared to the unmodified protein. Preparations containing novel isoforms may be used as standards to identify and characterize naturally occurring isoforms of native CC10 protein from blood or urine and ultimately to measure new CC10-based biomarkers to assess patient disease status. These preparations may also be used to treat respiratory, autoimmune, inflammatory, and other medical conditions that are not effectively treated with the unmodified protein.

Modification and compositions of human secretoglobin proteins

Methods of using recombinant human CC10 (rhCC10), also known as recombinant human uteroglobin, to reduce virus titers in the tissues of patients, particularly influenza and filovirus titers in lung tissues are provided. RhCC10 may be used as a therapeutic in the treatment, cure, or prevention of viral infection, particularly influenza and ebola infection. More particularly, methods, including broadly the critical dosage ranges of rhCC10, intravenous and intranasal route of administration, which may be administered to treat, cure or prevent influenza and ebola infection are provided. Further provided are compositions useful in the foregoing methods and in administering rhCC10 to humans.

Recombinant human CC10 protein for treatment of influenza and ebola

Methods of using recombinant human CC10 (rhCC10), also known as recombinant human uteroglobin, to reduce virus titers in the tissues of patients, particularly influenza titers in lung tissues are provided. RhCC10 may be used as a therapeutic in the treatment, cure, or prevention of viral infection, particularly influenza infection. More particularly, methods, including broadly the critical dosage ranges of rhCC10, intravenous and intranasal route of administration, which may be administered to treat, cure or prevent influenza infection are provided. Further provided are compositions useful in the foregoing methods and in administering rhCC10 to humans.

Recombinant human CC10 protein for treatment of influenza

The present invention relates generally to the use of recombinant human CC10 (rhCC10), also known as recombinant human uteroglobin, for use as a therapeutic in the treatment of Respiratory Distress Syndrome (RDS), Bronchopulmonary dysplasia (BPD), chronic lung disease and/or pulmonary fibrosis, Asthma and Chronic Obstructive Pulmonary Disease (COPD). More particularly, the invention provides methods, including broadly the critical dosage ranges of rhCC10, which may be administered to safely and effectively treat the aforementioned conditions. The invention further provides a composition useful in administering rhCC10 to humans.

Methods and compositions for the reduction of neutrophil influx and the treatment of bronchopulmonary displasia, respiratory distress syndrome, chronic lung disease, pulmonary fibrosis, asthma and chronic obstructive pulmonary disease

Methods and compositions for the reduction of neutrophil influx and for the treatment of bronchpulmonary dysplasia, respiratory distress syndrome, chronic lung disease, pulmonary fibrosis, asthma and chronic obstructive pulmonary disease

Disclosed are epitope-containing heat shock fusion proteins, DNA constructs encoding such fusion proteins, and methods of use. More specifically, disclosed are ubiquitin fusion proteins comprising ubiquitin fused to a plurality of identical or non-identical epitopes at specified locations.

Method for detection of specific antibodies using ubiquitin fusion proteins

The present invention relates generally to the production of recombinant human uteroglobin (rhUG) for use as a therapeutic in the treatment of inflammation and fibrotic diseases. More particularly, the invention provides processes, including broadly the steps of bacterial expression and protein purification, for the scaled-up production of rhUG according to current Good Manufacturing Practices (cGMP). The invention further provides analytical assays for evaluating the relative strength of in vivo biological activity of rhUG produced via the scaled-up cGMP processes.

Methods for the production of purified recombinant human uteroglobin for the treatment of inflammatory and fibrotic conditions

Ubiquitin fusion-based vaccine system

Heat shock fusion-based vaccine system

Method for treatment of inflammatory and fibrotic conditions in vivo using pure rhUG is disclosed. Method for treating or preventing inflammatory or fibrotic conditions characterized by a deficiency of endogenous functional UG is also disclosed. Compositions containing pure rhUG, optionally also containing lung surfactant, and assay procedures for detection of UG-fibronectin complexes, are also provided.

Use of recombinant human uteroglobin in treatment of inflammatory and fibrotic conditions

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Gaithersburg, MD, United States of America

Aprile L Pilon