FibroGenesis Advances Preclinical Data in Preparation for FDA Investigational New Drug Submission
HOUSTON, July 21, 2020 /PRNewswire/ -- FibroGenesis announced today new data supporting use of its PneumoBlast™ product in the battle against COVID-19. Using the widely accepted bleomycin model of lung scarring (fibrosis), Company scientists have demonstrated the administration and use of PneumoBlast™ induced a 51% reduction of lung fibrosis, which was statistically significant (p < .005). Importantly, when PneumoBlast™ was compared head to head with bone marrow derived mesenchymal stem cells (BMSCs) for COVID-19, PneumoBlast™ was 221% more effective. In producing the potent anti-inflammatory protein interleukin 1 receptor antagonist, which is believed to be the mechanism of scar tissue prevention by BMSC therapies currently in development, PneumoBlast™ was 192% more effective than BMSCs which was again, statistically significant (p < .005).
During an interview with Healthline.com, Dr. Lori Shah, transplant pulmonologist at New York-Presbyterian/Columbia University Irving Medical Center, stated "Holes in the lungs likely refers to an entity that has been dubbed 'post-COVID fibrosis,' otherwise known as post-ARDS [acute respiratory distress syndrome] fibrosis, which is irreversible and can result in severe functional limitations from patients, such as cough, shortness of breath, and need for oxygen." It has been reported that pulmonary fibrosis due to COVID-19 is occurring in increasing numbers of patients in their 20s and 30s.
"COVID-19 represents a new clinical entity which not only causes death through lung inflammation, but in some patients causes permanent lung injury through stimulation of scarring," said Tom Ichim, Ph.D., Chief Scientific Officer of FibroGenesis. "The prospects that our cell therapy approach not only possesses therapeutic effects on animal models of the acute stage of COVID-19, but also benefits the long-term pathology, has our research team extremely excited."
"As the scientific and medical community is discovering more about the biological and medical consequences of the COVID-19 infection, FibroGenesis is eager to contribute to the therapeutic cure options currently being created to fight this global war against an invisible enemy," commented Pete O'Heeron, President/CEO of FibroGenesis. "While we are excited about potential vaccines in the pipeline, the fact remains that there are 3.8 million confirmed cases of COVID-19 in the U.S. and we do not know what the long-term outcomes for these patients will be. To our knowledge, we are the only cell therapy company which is creating a therapy to resolve the initial pathology of infection and also proactively tackling its long-term consequences."
Based in Houston, Texas, FibroGenesis, is a regenerative medicine company developing an innovative solution for chronic disease treatment using human dermal fibroblasts. Currently, FibroGenesis holds 235+ U.S. and international issued patents/patents pending across a variety of clinical pathways, including Disc Degeneration, Multiple Sclerosis, Parkinson's, Chronic Traumatic Encephalopathy, Cancer, Diabetes, Liver Failure, Colitis and Heart Failure. Funded entirely by angel investors, FibroGenesis represents the next generation of medical advancement in cell therapy.