Specialty biotechnology company Discovery Laboratories has initiated four research projects designed to explore the use of its proprietary KL4 surfactant technology for the prevention and treatment of acute lung injury (ALI).  

Discovery Labs believes that KL4 surfactant may be an effective intervention for people at risk for, or with, ALI.  The company is collaborating with leading research institutions in a series of preclinical studies funded through various United States (US) Government-sponsored, biodefense-related initiatives.

Government support and interest in Discovery Labs' ALI programme stems from the passing of the Project Bioshield Act of 2004 and the Pandemic & All-Hazards Preparedness Act of 2006 by the US. Congress.  Both Acts encourage private sector development of medical countermeasures against chemical, biological, radiological, and nuclear terrorism threat agents, and pandemic influenza, and provide a mechanism for federal acquisition of such countermeasures.  Excluding these potential threats, approximately 40 percent of the nearly 200,000 ALI cases reported in the United States each year result in death.  In addition to high mortality, patients with ALI have considerable morbidity risk and face high healthcare costs. Discovery Labs believes that this population is severely underserved.

The four ALI research projects supported through the National Institutes of Health (NIH), US Department of Health and Human Services (DHHS), are :

A two-year, $600,000 Small Business Innovation Research (SBIR) phase 1 award to Discovery Labs from NIH's National Institute of Allergy and Infectious Diseases (NIAID) Center for Medical Counter Measures Against Radiation and Nuclear Threats to assess the ability of KL4 surfactant to mitigate the effects of acute radiation exposure to the lung, including acute pneumonitis and delayed lung injury.  Discovery Labs is collaborating with the University of Pennsylvania on this project.

Collaboration with the University of Rochester Center for Medical Countermeasures against Radiation, an NIH/NIAID-funded Center of Excellence, to evaluate the use of KL4 surfactant to protect the lung in a radiation-induced, multi-organ dysfunction animal model.

Collaboration with the CounterACT Efficacy Research Facility (CERF), supported under an Interagency Agreement with the Department of Defense through the NIH Office of the Director and the Countermeasures Against Chemical Threats (CounterACT) program.  The utility of KL4 surfactant for the treatment of chemical-induced ALI will be explored in a chemical-induced ALI model currently being developed by the CERF.  The CounterACT program supports basic, translational, and clinical research aimed at the discovery and/or identification of better therapeutic and diagnostic countermeasures against chemical threat agents, and facilitates their movement through the regulatory process.

Use of NIAID's Animal Models of Infectious Disease program to investigate the use of KL4 surfactant as a treatment for influenza-induced ALI with NIAID-funded contractors.

NIAID is the lead NIH Institute for infectious diseases research, including research and development of countermeasures against potential agents of bioterrorism in support of the Project Bioshield Act.

"We are very fortunate to have the opportunity to participate in these projects and explore the potential benefits of KL4 surfactant to address unmet needs in acute lung injury," said Dr. Robert Segal, sr. vice president, Government and Academic Affairs at Discovery Labs.  "While our short-term development priority is focused on neonatology applications, efforts such as these demonstrate the potential to apply and develop our technologies to advance new standards in respiratory critical care."

ALI is associated with conditions that either directly or indirectly injure the air sacs of the lung.  ALI is a syndrome of inflammation and increased permeability of the lungs with an associated breakdown of the lungs' surfactant layer.  Among the causes of ALI are complications typically associated with certain major surgeries, mechanical ventilator-induced lung injury (often referred to as VILI), severe acute respiratory syndrome (SARS), pneumonia and sepsis.  Direct injury of the lung leading to ALI can also occur from radiation or caustic chemical exposure.  There are a significant number of people at risk in the United States for ALI annually and there are no currently approved therapies other than supportive respiratory care.  Despite recent advances in understanding the pathophysiology, treatment, and long-term outcome of acute lung injury, morbidity and mortality related to ALI remains high.