Saturday, August 4, 2012

Elusys Awarded Additional $50.2 Million Under An Exisiting U.S. Government Contract To Support Final Stages Of Development Of ETI-204, For Treatment Of Inhalational Anthrax


PINE BROOK, N.J.,announced today that  Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing countermeasures for biodefense, announced today that it has been awarded additional funding from the U.S. Government, valued at $50.2 million, for the advanced development of ETI-204 (Anthim), an investigational agent for the treatment of anthrax infection following a biowarfare attack.  Anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Anthrax remains one of the nation's top biowarfare threats. Inhaled anthrax is often fatal, despite treatment with antibiotics. ETI-204 is an investigational anti-toxin and is a promising candidate for the treatment of inhalational anthrax in humans.

The $50.2 million awarded by the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, will be used to conduct definitive efficacy studies in animals and complete validation of the commercial manufacturing process for ETI-204. This third year of funding is in addition to $57.5 million the company already received under this contract and is part of a five year award totaling up to $143 million. This advanced product development contract is supporting Elusys' efforts to gain U.S. Food and Drug Administration (FDA) licensure, including manufacturing activities, human safety trials and non-clinical effectiveness studies in animals.

"We are pleased that the U.S. Government is continuing to support our efforts to advance ETI-204 through the final stages of our development program, including validation of our commercial manufacturing processes," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "We recently completed a clinical dose-escalation study and look forward to reviewing those data." The company's dose-escalation study, including a total of 108 human subjects, collected additional safety and pharmacokinetic (PK) data at doses up to 16 mg/kg, administered intravenously. Elusys has completed two other dose escalation safety studies in humans and a number of studies assessing activity of ETI-204 against anthrax in two animal species.

If all activities in the ETI-204 development program are completed to FDA's satisfaction, the federal government could purchase ETI-204 for the Strategic National Stockpile (SNS) under Project BioShield. Project BioShield was established in 2004 to provide much needed funding to procure important countermeasures to protect the American public in the event of a biowarfare attack. ETI-204 was granted Fast-Track status and Orphan Drug Designation in 2006 by the FDA.