San Diego, CA – March 12, 2012 – InflammaGen™ Therapeutics, a development-stage, critical care company initially focused on the diagnosis, treatment and prevention of multi-organ failure (MOF), announced today that the Company has initiated a 200-patient Phase 2 pilot study to examine the efficacy and safety of InflammaGen Shok-Pak as a potential treatment for critically ill patients in the Intensive Care Unit (ICU). Conditions expected to qualify for the study include new-onset sepsis and septic shock, post-operative complications and new-onset gastrointestinal bleeding.
The InflammaGen Shok-Pak is the result of decades of research by University of California, San Diego Bioengineering Professor Geert Schmid-Schönbein on the microvascular and cellular reactions that lead to organ failure after a patient has gone into shock, which is the second-leading cause of in-hospital deaths in the United States. Schmid-Schönbein and his colleagues at the UC San Diego Jacobs School of Engineering discovered that under conditions of shock, the epithelial cell barrier that lines the small intestine becomes permeable thereby causing potent digestive enzymes to be carried into the bloodstream and lymphatic system where they digest and destroy healthy tissue, a process he named Autodigestion. With the InflammaGen Shok-Pak, an enzyme inhibitor is administered directly into the stomach and lumen of the intestine, blockading the enzymes.
To date, the technology has been used successfully outside the United States as a rescue therapy in 15 patients, most of whom were diagnosed with life-threatening conditions. In addition, pre-clinical studies of InflammaGen Shok-Pak in two animal species have demonstrated significant increases in long-term survival.
“Currently, patients in shock who survive their initial insult don’t necessarily survive long-term. In addition, morbidity is very high in those patients that do survive. Our animal studies suggest that InflammaGen Shok-Pak could improve functional outcomes and reduce the time patients remain in intensive care, as well as increase long-term survival rates,” said principal investigator Dr. Erik Kistler, who currently serves as an assistant clinical professor in the Department of Anesthesiology and Critical Care at the UC San Diego School of Medicine and the Veterans Administration Healthcare System, San Diego. “While ICU costs can approach one-third of the entire hospital costs, decreasing ICU time by even a small percentage a day will have significant financial savings for patients and payors as well as result in significantly improved patient wellness,” said Kistler.
"We are testing for the first time whether it is possible to help severely ill patients by blocking autodigestion, a condition in which digestive enzymes not only break down food inside the intestine but also the intestine itself,” Schmid-Schönbein said. “We have pre-clinical results that this blockade can save lives.”
The Phase 2 pilot is designed as a double-blind, standard-therapy controlled study of 200 critically ill ICU patients. The primary endpoint is to provide preliminary efficacy and safety data on the gastrointestinal administration of InflammaGen Shok-Pak in the reduction of morbidity at discharge or at day 28. The secondary endpoint is the efficacy of InflammaGen Shok-Pak in reducing ICU and hospital length-of-stay, as well as morbidity and mortality at six months. The Phase 2 pilot study will be conducted at the ICU at the Veterans Administration San Diego Healthcare System, with additional sites being added as appropriate.
John Rodenrys, CEO of InflammaGen Therapeutics, remarked, “Initiation of the Phase 2 pilot study is a key milestone in the development of InflammaGen Shok-Pak as a potential treatment for sepsis and septic shock, which may result in multi-organ failure, a highly-invasive condition for which there is currently no effective therapy option.”
Hank Loy, president of InflammaGen Therapeutics, added, “We look forward to working with the investigative team at the VA San Diego Healthcare System and expect their experiences to demonstrate the benefits of InflammaGen Shok-Pak, which have been evident in the pre-clinical studies and ex-U.S. patient experiences.”
InflammaGen Shok-Pak was developed based on Schmid-Schönbein’s research at the UC San Diego Jacobs School of Engineering and was supported by the NIH and the von Liebig Center at UC San Diego. Schmid-Schönbein was awarded the 2008 Landis Award for his discovery.
About Multi-Organ Failure
Multi-organ failure is a potentially life-threatening disturbance in normal organ function caused by acute shock (trauma, sepsis, burn and SIRS). Without swift medical intervention, the patient’s organs will progressively continue to fail, decreasing one’s chances of survival. In the United States, shock is the second leading cause of in-hospital deaths, with approximately 750,000 cases occurring annually.1 It is estimated that between 28 and 50 percent of these patients die, exceeding the number of U.S. deaths from prostate cancer, breast cancer and AIDS combined.2 In 2007, sepsis accounted for an estimated $38 billion in hospital billings.
1. Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome and associated costs of care. Critical Care Medicine. 2001 Jul;29(7):1303-10
2. Wood KA, Angus DC. Pharmacoeconomic implications of new therapies in sepsis. PharmacoEconomics. 2004;22(14):895-906.
About InflammaGen™ Therapeutics
InflammaGen Therapeutics is a development-stage, critical care company initially focused on the diagnosis, treatment and prevention of multi-organ failure (MOF), a condition with a high mortality rate and very few therapeutic options. The Company’s lead technology is InflammaGen Shok-Pak, a drug/delivery platform designed to prevent the onset of shock and MOF via the direct administration of an enzyme inhibitor into the stomach and lumen of the intestine. InflammaGen Shok-Pak was developed based on research from the University of California, San Diego, which demonstrated that under conditions of shock, digestive enzymes permeate the wall of the intestine and enter the bloodstream, leading to multi-organ failure and death. Complementing InflammaGen Shok-Pak, the Company has also developed a diagnostic assay – AnaZyme – that uses either breath or blood samples to measure the presence and severity of inflammatory activity due to shock, and InflammaGen Lavage, a therapeutic for use in open wounds and areas of infection. InflammaGen Therapeutics is a Leading Biosciences' company. For additional information on Leading Biosciences, please visit http://leadingbiosciences.com/. For additional information on InflammaGen Therapeutics or its MOF treatment platform, please visit http://igenrx.com/