Presentation to Highlight Patient Experience and Recovery from Multiple Organ Failure
Phase 2 Pilot Study Expected to Commence by Year End 2011
San Diego, CA & Düsseldorf, Germany - October 31, 2011 - InflammaGenTM Therapeutics, a development-stage, critical care company initially focused on the diagnosis, treatment and prevention of Multiple Organ Failure (MOF), announced today that the Company will present a case review during BIO-Europe 2011 detailing the first-ever in-human experience involving InflammaGen Shok-Pak. The case review will be presented by Hank Loy, president of InflammaGen Therapeutics, on Tuesday, November 1 at 11:00 a.m., CET (6:00 a.m., ET) on Level 2, Room 26 at the CCD Conference Center in Düsseldorf, Germany.
InflammaGen Shok-Pak is a drug/delivery technology 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. A Phase 2 pilot study of the InflammaGen Shok-Pak is expected to begin by year end 2011.
John Rodenrys, CEO of InflammaGen Therapeutics, commented, "We welcome the opportunity to present this case review at BIO-Europe 2011 to showcase the value of InflammaGen Shok-Pak as a potential treatment for shock and MOF. Our pre-clinical research and patient experiences have demonstrated that blocking the release of digestive enzymes from the intestine to the bloodstream appears to play a critical role in treating and reversing shock and MOF, thereby enabling those inflicted with the condition to recover and survive. We look forward to continuing the clinical development of this unique technology with the initiation of a Phase 2 pilot study."
The case review at BIO-Europe 2011 highlights the recovery of a 58 year-old male patient and prior cardiac transplant survivor who was treatedwith InflammaGen Shok-Pak after being diagnosed with Fournier's gangrene and acute septic shock. The patient was the first human treated with InflammaGen Shok-Pak, which has now been used outside the U.S. as a rescue therapy for 13 patients, all of whom were diagnosed with life-threatening conditions. In addition to the successful ex-U.S. human experiences, pre-clinical studies of InflammaGen Shok-Pak in two animal species have demonstrated significant increases in long-term survival.
Mr. Loy remarked, "Despite the prevalence and severity of MOF, current therapies to treat this potentially grave condition are limited both in availability and effectiveness. Our therapeutic and diagnostic platform is being developed to address this severe medical need, and we believe it may eventually offer a significant breakthrough in the survivability of shock and MOF patients."
InflammaGen Shok-Pak was developed based on research from the University of California, San Diego. Dr. Geert Schmid-Schonbein, lead investigator, and colleagues discovered that under conditions of shock, the epithelial cell barrier in the small intestine becomes permeable causing highly potent digestive enzymes to be carried into the bloodstream and lymphatic system where they can lead to MOF and death. Dr. Schmid-Schonbein and his colleagues demonstrated that by delivering an enzyme inhibitor directly into the lumen of the intestine via a nasogastric tube they could block the digestive enzymes, thereby inhibiting the progression from acute shock to MOF. Dr. Schmid- Schonbein was awarded the 2008 Landis Award for this discovery, termed Autodigestion.
InflammaGen Therapeutics is also developing a tandem diagnostic, AnaZyme, which is designed to detect the onset and severity of shock from either breath or blood samples. AnaZyme is intended to be used in critical care situations to enable first responders, nurses and physicians to identify the signs of shock before it cascades to MOF, enabling healthcare workers to quickly administer InflammaGen therapy following the technologies' approval by the FDA and other regulatory agencies.
About Multiple Organ Failure
Multiple Organ Failure (MOF) is a potentially life-threatening disturbance in normal organfunction caused by acute shock (trauma, sepsis, burn, SIRS, etc). 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 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 InflammaGenTM Therapeutics
InflammaGen Therapeutics is a development-stage, critical care company initially focused on the diagnosis, treatment and prevention of Multiple 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/.