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-Schonbein 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-Schonbein 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-Schonbein 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-Schonbein'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-Schonbein was awarded the 2008 Landis Award for his discovery.