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NexBio’s DAS181 (Fludase®*) Improved Symptoms in a Severely Immunocompromised Patient with Parainfluenza Pneumonitis
Date:2/17/2011

SAN DIEGO, Feb. 17, 2011 /PRNewswire/ -- NexBio, Inc. announced the presentation of "Treatment of Parainfluenza 3 Infection with DAS181 in a Patient after Allogeneic Stem Cell Transplantation" at the American Society for Blood and Bone Marrow Transplant meeting February 17-21 in Honolulu, Hawaii.  The data was presented by Dr. Yi-Bin Chen, Department of Medicine, Massachusetts General Hospital and Harvard Medical School.

Parainfluenza virus (PIV) infection causes Influenza-like-Illness (ILI), a common respiratory disease.  Parainfluenza can result in significant morbidity and mortality in immunocompromised patients.  The current standard treatment for PIV infection is supportive care as there are no approved drugs or vaccines for the infection.  DAS181 is an investigational antiviral medication with preclinical activity in vitro and in vivo against PIV and influenza viruses (IFV).  The receptor for both PIV and IFV on airway epithelial cells is sialic acid.  DAS181, a recombinant sialidase fusion protein, removes sialic acid residues from airway epithelium, thereby preventing both the initial step in PIV and IFV infection and the spread of existing infection.  DAS181 is currently being studied in a Phase II clinical trial (http://flugotyoublue.com/) enrolling subjects with ILI in the United States. This study is funded by the National Institute of Allergy and Infectious Disease, National Institutes of Health.

DAS181 was administered to a bone marrow transplant patient who had progressive and worsening PIV-3 infection under an Emergency Investigational New Drug Application, as permitted by the Food and Drug Administration. This is the first reported treatment with DAS181 of a patient with PIV infection after allogeneic stem cell transplantation.  

Within one day of initiating treatment, the patient's respiratory status had improved, and by day three the patient no longer required supplemental oxygen. In addition, Pulmonary Function Tests showed an improvement in the patient's lung function. The measurement of virus in the upper respiratory tract (i.e., viral load) decreased for approximately three logs with treatment, as demonstrated by Quantitative Polymerase Chain Reaction.  In vitro testing in cultured cells confirmed the sensitivity of the patient's PIV clinical isolate to DAS181. The patient was discharged home, but was readmitted one week later with relapse of Acute Myeloid Leukemia.

"After treatment with DAS181 there was documented improvement in the patient's pulmonary function and reduction in viral load, and the patient's respiratory symptoms improved sufficiently to allow for the discontinuation of supplemental oxygen," said Dr. Ronald Moss, NexBio's Executive Vice President of Clinical Development and Medical Affairs.  "There are currently no treatments for PIV, which can be fatal in immunocompromised individuals. This novel investigational medicine should be studied further for this area of unmet medical need," he added.

"We are executing a broad clinical development plan for DAS181 that includes the goal of demonstrating activity against influenza as well as parainfluenza," said Dr. David Wurtman, NexBio's Vice President of Corporate Development. "In addition, a large body of preclinical data has shown activity of DAS181 for airway disease, and a clinical study of DAS181 in asthmatic patients is ongoing at the NIH clinical center to test this possible second indication in people. Based on these ongoing and future studies, we are hoping to demonstrate a broad clinical utility for DAS181," he added.

ABOUT NEXBIO

NexBio, Inc. is a privately held clinical-stage biopharmaceutical company located in San Diego.  NexBio's mission is to save lives and to improve the quality of life by creating and commercializing novel, broad-spectrum biopharmaceuticals to prevent and treat current and emerging life-threatening diseases.  DAS181 (Fludase®) is an investigational drug in Phase 2 clinical trial that consists of an inhaled recombinant fusion protein.  It inactivates viral receptors on the cells of the human respiratory tract, thereby preventing and treating infection by influenza, including potential pandemic strains, and by parainfluenza viruses (which may cause serious respiratory illness similar to influenza and for which there is no approved vaccine or therapeutic).  The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, under BAA Contract HHSN266200600015C and grant U01-AI070281. Sepcidin™, invented and developed by NexBio, is a parenteral protein at pre-clinical lead optimization stage, directed to the treatment of sepsis/SIRS, viral hemorrhagic fevers, bacterial biothreat agents.  TOSAP®, a technology invented and developed by NexBio, is used to formulate DAS181 for inhalation, as well as to make microparticles from virtually any type of large and small molecule, and combinations of molecules. TOSAP is offered for the formulation of compounds of partners, under license.

For more information about NexBio, Inc., please visit http://www.nexbio.com

* FDA has yet to approve the name FludaseContact:David Wurtman, M.D., M.B.A.VP, Corporate DevelopmentNexBio, Inc.10665 Sorrento Valley RoadSan Diego, CA  92121Phone: (858) 452-2631dwurtman@nexbio.com
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SOURCE NexBio, Inc.
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