Interventional Concepts and Immunotrex partner for a Phase 0 study to be conducted in Colombia on a novel anti-sepsis compound

Immunotrex Biologics —a Boston-based biotech startup company developing a novel anti-sepsis compound capable of blocking the multiple pathophysiologic processes involved in sepsis— has selected Interventional Concepts —a leading US-based contract research organization for innovative life science startup companies— to design a Phase 0 human study to understand the effects of the compound in the human system and how the human body processes it. Immunotrex intends to conduct this study at a clinical research center in Colombia. Interventional Concepts, through a strategic alliance with JSS Research, will design the study, will select the center and principal investigator in Colombia, and will facilitate the regulatory approval process, among other activities necessary to make the study a success in Colombia.

Sepsis has been named as the most expensive in-patient cost in American hospitals in 2011 at over $20 billion each year. Forty percent of patients diagnosed with severe sepsis do not survive. Until a cure for sepsis is found, early detection is the surest hope for survival. Up to 50% of survivors suffer from post-sepsis syndrome. In the U.S., sepsis is the second-leading cause of death in noncoronary intensive care unit (ICU) patients and the tenth-most-common cause of death overall (the first being heart disease), according to data from the Centers for Disease Control and Prevention (CDC). It is a major cause of death in ICUs worldwide, with mortality rates ranging from 20% for sepsis to 40% for severe sepsis, and to >60% for septic shock, a medical emergency caused by decreased tissue perfusion and oxygenation. Severe sepsis is one of the most significant challenges in critical care. Each year, more than 750,000 people in the U.S. will develop severe sepsis, more than heart attacks, lung cancer, and other commonly known causes of death in the hospital. Treating patients with severe sepsis costs U.S. hospitals nearly $17 billion a year. There are three cases of severe sepsis per 1,000 population and 2.26 cases per 100 hospital discharges. With standard supportive care alone, mortality remains unacceptably high, at 28-50%. Severe sepsis causes 215,000 deaths in the U.S. each year—more than heart attacks, lung cancer, and other commonly known causes of death in the hospital.

Immunotrex has developed several novel therapeutic agents/compounds for the treatment of sepsis, referred to as KDEON™. These are novel small peptides (11 or 12 amino acids long) created by rational design aimed at neutralizing and blocking the injurious effects of endotoxins and thereby capable of blocking the multiple deleterious pathophysiological processes involved in sepsis. Immunotrex has successfully worked with students from the University of Massachusetts Lowell to develop and manufacture its anti-sepsis compound.

“We are very excited to be working with International Concepts on our novel anti-sepsis treatment (KDEONTM); Immunotrex looks to fast track this crucial life-saving therapeutic into hospitals to save patients lives when facing septic shock,” said Syed K. Hasan, Immunotrex' founder, president & CEO.

"We are proud of being part of the development of this breakthrough anti-sepsis compound," stated Julio G. Martinez-Clark, Interventional Concepts' president & CEO, "our team is committed to helping companies like Immunotrex develop their life-saving innovations, and Colombia is uniquely position to be the most cost-effective destination in Latin America for this type of clinical studies ."

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About Interventional Concepts, Inc.: Interventional Concepts was founded in 2010 in Miami, FL by Dr. Pedro Martinez-Clark, a Harvard-trained physician, and medical innovator— is dedicated to helping innovative life science startup companies validate their technologies at leading research institutions. The company provides clinical study design, regulatory, operational and logistics support services with a special focus in Colombia.


About Immunotrex Biologics, Inc.: Immunotrex Biologics is an emerging medical technology company committed to the development of innovative diagnostic and therapeutic products that satisfy key unmet needs in medicine. The company has laboratory space in Lowell MA and is developing two major products: an automated system for the rapid identification of infectious agents, and a therapeutic agent aimed at the treatment of sepsis. Mosaic™ is an automated point-of-care platform for the rapid identification of pathogenic bacteria and viruses using DNA-RNA hybridization in the hospital or diagnostic laboratory setting. KDEON™ is the company’s therapeutic agent for septic shock, based on a family of small peptides that block the injurious effects of lipopolysaccharide (LPS), a component of bacterial cell walls.