New Bioterrorism Vaccine Gets First Test In Humans

GAITHERSBURG, Md., Feb. 26, 2013 /PRNewswire/ -- Integrated BioTherapeutics (IBT) announces the initiation of a Phase 1 clinical trial testing the safety and immunogenicity of its staphylococcal enterotoxin B vaccine "STEBVAX" in healthy adults.

This trial, marking the first time a superantigen vaccine has been administered to humans, is designed to enroll 28 individuals. STEBVax is a proprietary, rationally designed and attenuated form of Staphylococcal Enterotoxin B (SEB), a member of a group of toxins called superantigens due to the ability to cause a massive inflammatory response leading to toxic shock.

"SEB is a biowarfare threat to the US and the superantigens can be critical factors affecting the outcome of Staphylococcus aureus infections," said Dr. M. Javad Aman, IBT President and Chief Scientific Officer. "This clinical study advances our vaccine programs designed to protect military and civilian populations against the threat of SEB and our long-term goal of developing vaccines and therapeutics for Staphylococcus aureus."

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have sponsored the clinical trial. The trial is being conducted at the Center for Vaccine Development at the University of Maryland in Baltimore, which is one of NIAID's Vaccine and Treatment Evaluation Units (VTEUs). 

"We are extremely pleased to see a decade-long research and development effort, which was heavily supported by the government, reach this critical milestone," Aman said. "Safety evaluation of STEBVax is significant as it is the first time a vaccine for such a potent toxin is being tested in humans."

IBT, a biotechnology company developing medical countermeasures for biodefense and emerging infectious diseases, is dedicated to the development of vaccines, immunotherapeutics and discovery of small molecules targeting emerging infectious agents.  IBT was named Outstanding Company of 2011 by the Maryland Technology Development Corporation (TEDCO), recognizing the company's tremendous growth in funding and personnel, and its strong relationships with the U.S. Government and industry partners. 

For more information, visit the ClinicalTrials.gov page here.

About Integrated BioTherapeutics Inc:

Integrated BioTherapeutics Inc (IBT) is an emerging research-based company dedicated to development of vaccines, immunotherapeutics, and discovery of small molecules targeting emerging infectious agents.  IBT has a portfolio of proprietary recombinant technologies for development of vaccines and immunotherapeutics against major biodefense and emerging infectious agents, with an emphasis on staphylococcal, and streptococcal infections, as well as viral hemorrhagic fevers. IBT has experience with many U.S. government agencies including the U.S. Army Medical Research Institute of Infectious Diseases, National Cancer Institute, National Institute of Health, and the Department of Defense.  IBT has established cooperative relationships with pharmaceutical and biotechnology companies for development of joint products for prevention and treatment of staphylococcal infections and viral hemorrhagic fevers.  IBT is funded through government grants, contracts and revenue from its CRO division, IBT Bioservices. For more information visit www.integratedbiotherapeutics.com. 

About Staphylococcal Enterotoxin B:

The Staphylococcus aureus and Streptococcus pyogenes bacteria release superantigens during an infection. SEB is one of the most potent superantigens. When purified, SEB is a potential bioweapon and was pursued by the US and USSR prior to an international ban on offensive biological and chemical weapons. STEBVax is considered a stand-alone vaccine for biodefense applications but is also a component of IBT's multivalent vaccine for prevention and treatment of staphylococcal infections in civilian life, a pressing public health problem in light of growing antibiotic resistance. The prospective multivalent vaccine will contain additional toxoids including other attenuated superantigens and pore-forming toxins currently in pre-clinical development at IBT.

CONTACTS:  Molly Boyle
202-777-3668 
molly.boyle@fpmgi.com

SOURCE Integrated BioTherapeutics Inc