Healthcare Industry News: Fludase
News Release - August 31, 2011
NexBio's DAS181 (Fludase(R)*) Improves Symptoms in Four Severely Immunocompromised Patients With Life-Threatening Parainfluenza PneumonitisSAN DIEGO, Aug. 31, 2011 -- (Healthcare Sales & Marketing Network) -- NexBio, Inc. announced publication of "Treatment of Parainfluenza 3 Infection with DAS181 in a Patient after Allogeneic Stem Cell Transplantation" in the Journal Clinical Infectious Diseases. The lead author, Dr. Yi-Bin Chen, of the Department of Medicine, Massachusetts General Hospital and Harvard Medical School, is the treating physician for the first of these patients.
The current publication describes the administration of DAS181 to a bone marrow transplant patient who had progressive and worsening Parainfluenza Virus Type 3 (PIV3) infection under an Emergency Investigational New Drug Application (eIND) granted by the Food and Drug Administration (FDA). This was the first reported treatment with DAS181 of a patient with PIV infection after allogeneic stem cell transplantation. Due to the lack of specific treatment for PIV, immunocompromised patients who acquire PIV infection have a high risk of developing infections to the lower respiratory tract and carry a mortality of 30- 40%.
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 by approximately three logs in three days, 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.
Dr. Yi-Bin Chen commented on the results: "The treatment with DAS181 was associated with a beneficial impact on this patient's respiratory status. There was a very rapid improvement in symptoms and the viral load data supports an antiviral effect against PIV3. The outcome warrants a further investigation with controlled clinical trials of DAS181 to address this area of important unmet medical need."
Since the time of this use of DAS181 under eIND, the drug has been administered to three additional immunocompromised patients, all of whom had PIV pneumonitis. Of these four total patients, two had undergone allogeneic stem cell transplantation, and two had undergone lung transplantation (and were on chronic multi-drug immunosuppression). In all four cases, use of DAS181 was associated with significant improvement in clinical symptoms. Data on the three new eIND cases will be presented at a major infectious disease meeting in the near future.
PIV infection causes Influenza-like Illness (ILI), a common respiratory disease, in the healthy population. Parainfluenza can result in significant morbidity and mortality in immunocompromised patients. There are no approved drugs (or vaccines) for PIV infection and the current standard treatment is supportive care. DAS181 is an investigational antiviral medication with preclinical activity in vitro and in vivo against PIV and against all types and strains of influenza viruses (IFV) tested. 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 as well as the spread of existing infection. DAS181 is also currently in clinical development for the treatment and prevention of influenza.
"There is no approved treatment for PIV, which can be fatal in immunocompromised individuals, and which is a common cause of flu-like symptoms in the general population," said Fang Fang, MD, PhD, NexBio's President of Research and Development. "We are executing a broad clinical development plan for DAS181 that includes the goal of demonstrating activity against influenza as well as parainfluenza," she added.
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 development 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. SepcidinTM, 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 Fludase
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