Elusys to launch three human safety studies, including safety of ETI-204 administered via intramuscular injection (IM)
PINE BROOK, NJ,USA I September 13, 2012 I 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 $14.5 million, to support expanded human safety studies of ETI-204 (Anthim), an investigational agent for the treatment of anthrax infection following a biowarfare attack. The company has now received $149 million, under two advanced development contracts with a potential total value of $211 million, from the Biomedical Advanced Research and Development Authority, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. ETI-204 is an investigational anti-toxin and is a promising candidate for the treatment of inhalational anthrax in humans.
Anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation’s top biowarfare threats. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Inhaled anthrax is often fatal, despite treatment with antibiotics.
The $14.5 million funding will be used to conduct final, expanded safety studies for intravenous (IV) administration of ETI-204, as well as a dose escalation safety study for intramuscular (IM) administration of the anti-toxin. IM administration would allow rapid administration of anti-toxin treatment to large numbers of people in an emergency setting. Elusys has also received funding previously from the U.S. Department of Defense to support the development of its IM formulation.
"As we continue to reach milestones in the late stages of our development program, we are pleased to have the ongoing support of the U.S. Government to evaluate not only IV administration but also the more rapid, cost-effective IM administration of ETI-204," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "Advancing the development of both IV and IM administration of our anti-toxin could provide two important options in the prevention and treatment of inhalational anthrax following a biowarfare attack."
Elusys continues to work closely with the U.S. Food and Drug Administration (FDA) on the design of the ETI-204 Phase 3 development program in preparation for an anticipated End of Phase 2 meeting. ETI-204 was granted Fast Track status and Orphan Drug Designation in 2006 by the FDA.
About ETI-204
ETI-204 is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to Protective Antigen. It is an investigational agent being developed for treatment of inhalational anthrax following a biowarfare attack.
ETI-204 efficacy and safety are being studied in animals and safety studies are being conducted with human volunteers. To date, five studies assessing the efficacy and safety of ETI-204 in animals with inhalational anthrax have been completed, and three studies assessing pharmacokinetics and safety of IV administration of ETI-204 in humans have been conducted. In the two completed studies, the adverse event profile of ETI-204 was comparable to placebo and the more common adverse events related to ETI-204 administration were headache and upper respiratory tract infection. ETI-204 is formulated as a solution suitable for either IV or IM administration. This program is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services (HHS) under Contract Nos. HHSO100201000026C and HHS0100201100034C.
About Elusys Therapeutics, Inc.
Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of life-threatening disease. Elusys has been engaged in development of biodefense countermeasures since 2000. The company has established experience in government contract management and to date has received multiple grants and has the potential to receive, in total, up to $211 million in government funding. ETI-204, a highly effective, anthrax anti-toxin, is in late-stage development and is a strong candidate for future procurement into the Strategic National Stockpile. For more information, please visit www.elusys.com.
SOURCE: Elusys Therapeutics
Post Views: 59
Elusys to launch three human safety studies, including safety of ETI-204 administered via intramuscular injection (IM)
PINE BROOK, NJ,USA I September 13, 2012 I 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 $14.5 million, to support expanded human safety studies of ETI-204 (Anthim), an investigational agent for the treatment of anthrax infection following a biowarfare attack. The company has now received $149 million, under two advanced development contracts with a potential total value of $211 million, from the Biomedical Advanced Research and Development Authority, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. ETI-204 is an investigational anti-toxin and is a promising candidate for the treatment of inhalational anthrax in humans.
Anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation’s top biowarfare threats. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. Inhaled anthrax is often fatal, despite treatment with antibiotics.
The $14.5 million funding will be used to conduct final, expanded safety studies for intravenous (IV) administration of ETI-204, as well as a dose escalation safety study for intramuscular (IM) administration of the anti-toxin. IM administration would allow rapid administration of anti-toxin treatment to large numbers of people in an emergency setting. Elusys has also received funding previously from the U.S. Department of Defense to support the development of its IM formulation.
"As we continue to reach milestones in the late stages of our development program, we are pleased to have the ongoing support of the U.S. Government to evaluate not only IV administration but also the more rapid, cost-effective IM administration of ETI-204," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "Advancing the development of both IV and IM administration of our anti-toxin could provide two important options in the prevention and treatment of inhalational anthrax following a biowarfare attack."
Elusys continues to work closely with the U.S. Food and Drug Administration (FDA) on the design of the ETI-204 Phase 3 development program in preparation for an anticipated End of Phase 2 meeting. ETI-204 was granted Fast Track status and Orphan Drug Designation in 2006 by the FDA.
About ETI-204
ETI-204 is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to Protective Antigen. It is an investigational agent being developed for treatment of inhalational anthrax following a biowarfare attack.
ETI-204 efficacy and safety are being studied in animals and safety studies are being conducted with human volunteers. To date, five studies assessing the efficacy and safety of ETI-204 in animals with inhalational anthrax have been completed, and three studies assessing pharmacokinetics and safety of IV administration of ETI-204 in humans have been conducted. In the two completed studies, the adverse event profile of ETI-204 was comparable to placebo and the more common adverse events related to ETI-204 administration were headache and upper respiratory tract infection. ETI-204 is formulated as a solution suitable for either IV or IM administration. This program is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services (HHS) under Contract Nos. HHSO100201000026C and HHS0100201100034C.
About Elusys Therapeutics, Inc.
Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of life-threatening disease. Elusys has been engaged in development of biodefense countermeasures since 2000. The company has established experience in government contract management and to date has received multiple grants and has the potential to receive, in total, up to $211 million in government funding. ETI-204, a highly effective, anthrax anti-toxin, is in late-stage development and is a strong candidate for future procurement into the Strategic National Stockpile. For more information, please visit www.elusys.com.
SOURCE: Elusys Therapeutics
Post Views: 59
