InflammaGen is launching a Phase II pilot study of its device that delivers a treatment for self-digestion, a gross phenomenon in which the body starts essentially eating its organs after going into shock.
Plans call for holding a double-blind, standard-therapy controlled study of 200 critically ill ICU patients. Researchers will primarily assess the company's Shok-Pak device as to how often it prevents death during its use or after 28 days. Patients at the Veterans Administration San Diego HealthCare System will take part in the study. The scientists will gather preliminary safety and effectiveness data on the device, which is intended to address a particularly nasty condition known both as "self-digestion" and "auto-digestion."
What is this horrible state, you might be asking? Well, the treatment is necessary for some people who go into shock and develop this. Such a condition can set off a nasty process, as FierceBiotech's Ryan McBride explained to you in November, in which the small intestine's natural barriers start to break down, releasing digestive enzymes that eat organ tissue. If left unchecked, organs can fail, and death quickly follows.
Shock-Pak is designed to reverse the awful condition by delivering an enzyme inhibitor into the stomach and lumen of the intestine by way of a nose tube.
The University of California, San Diego's Dr. Geert Schmid-Schonbein developed the research behind the technology, which investors spun off into the fledgling startup. To date, the company claims it has tested its system successfully on 15 patients outside of the U.S. and two unnamed animal species, though the company hasn't shared detailed study results yet.
- here's the release