ROSALIND FRANKLIN UNIVERSITY STARTUP PREPARING FOR FDA IND FILING AND A PIVOTAL CLINICAL TRIAL ON NOVEL THERAPY FOR SUDDEN CARDIAC ARREST
NORTH CHICAGO, Ill., Feb. 2, 2023 /PRNewswire/ -- Rosalind Franklin University of Medicine and Science (RFU) announced today that one of its early-stage companies — Resuscitation Therapeutics (RTx), which is focused on developing new therapies for life-threatening acute cardiovascular events — is preparing an Investigational New Drug (IND) application for submission to the U.S. Food and Drug Administration proposing a novel treatment for sudden cardiac arrest (SCA).
More than 350,000 people suffer an episode of out-of-hospital cardiac arrest (OHCA) each year in the U.S. but less than 10% survive. A major obstacle to survival is reperfusion injury, which occurs during CPR when oxygenated blood is returned to a heart muscle that has been deprived of oxygen for several minutes. The injury reduces the heart's ability to pump after resuscitation.
The IND application is for the use of the hormone erythropoietin (EPO) to ameliorate reperfusion injury during CPR. RTx is looking to finalize its IND application during the first quarter of 2023 and to undertake a multi-center clinical trial early next year.
RTx was founded in 2017 by Dr. Raúl J. Gazmuri, FCCM, a professor of medicine and professor of physiology and biophysics at RFU's Chicago Medical School, and chief of Critical Care Medicine and ICU director at the neighboring Captain James A. Lovell Federal Health Care Center. The company is rooted in decades of preclinical research at the university's Resuscitation Institute, directed by Dr. Gazmuri, who discovered the benefits of ameliorating reperfusion injury during CPR through the use of compounds known as NHE-1 inhibitors. Although NHE-1 inhibitors are not currently available for clinical use, the research pointed to EPO, which is approved by the FDA for the treatment of anemia in patients with chronic kidney disease. Work at the Resuscitation Institute and a pilot clinical study in Slovenia supported the role of EPO for cardiac resuscitation and led to patents that provide exclusivity for its use in this new indication.
Two key milestones were achieved by RTx in the fourth quarter of 2022: the first, a favorable pre-IND meeting with the FDA's Division of Cardiology and Nephrology, and second, the securing of an exclusive option with RFU to license the patents for this new indication.
The clinical trial will assess the effects of administering EPO during CPR in adult victims of OHCA. The primary outcome will be 72-hour survival. Several additional outcomes will be assessed, including survival at 90 days and whether those who survive do so with adequate brain function. A positive result of the clinical trial will pave the way for FDA approval for clinical use and subsequent commercialization.
"SCA is a deadly condition where little progress has been made and no therapies targeting reperfusion injury for cardiac resuscitation have come to the market," said RTx Chief Operating Officer Dr. Iyad Ayoub. "We are very encouraged by our FDA pre-IND meeting and the guidance provided."
RFU Executive Vice President for Research Dr. Ronald Kaplan commended the progress made by RTx based on the internationally-recognized research conducted by the Resuscitation Institute.
"It's our great hope," he said, "that this potential therapeutic solution for sudden cardiac arrest will save many lives in the U.S. and around the world."
Find more information on RFU Helix 51 incubator companies and RTx Inc.
Office of Marketing and Communications
View original content to download multimedia:https://www.prnewswire.com/news-releases/rosalind-franklin-university-startup-preparing-for-fda-ind-filing-and-a-pivotal-clinical-trial-on-novel-therapy-for-sudden-cardiac-arrest-301737739.html
SOURCE Rosalind Franklin University of Medicine and Science