Phase II study underway of Shok-Pak (Inflammagen Therapeutics) for patients with Shock

A 200-patient Phase II pilot study has begun to examine the efficacy and safety of the Shok-Pak, from InflammaGen Therapeutics, as a potential treatment for critically ill patients suffering from Multiple Organ Dysfunction Syndrome (MODS), formally known as multiple organ failure. Conditions expected to qualify for the study include new-onset sepsis and septic shock, post-operative complications and new-onset gastrointestinal bleeding. Under conditions of shock, the epithelial cell barrier becomes permeable and the highly active and potent digestive enzymes are carried into the wall of the intestine where they start to break down the intestinal wall. Shok-Pak is designed to inhibit the progression from Acute Shock to MODS by delivering an enzyme inhibitor directly into the lumen of the intestine, via a NG tube, thereby blocking the digestive enzymes. To date, the technology has been used successfully outside the US 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. 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 study will be conducted at the ICU at the Veterans Administration San Diego Healthcare System, with additional sites being added as appropriate.