San Carlos, CA. - November 24, 2021 - Regencor announced today that the Application Review Subcommittee of the California Institute for Regenerative Medicine (CIRM) awarded Regencor $3.9M for the performance of IND-enabling studies of their proprietary cardio-regenerative recombinant human protein, FSTL1. This new award builds upon the Company’s large animal studies which have confirmed and extended the cardiac regenerative effects originally published in Nature (24 Sept 2015, 525, 479-485) by the Company’s founders, Mark Mercola, PhD, and Pilar Ruiz-Lozano, PhD, the Company’s Chief Scientific Officer, and the PI of the new CIRM grant.
Heart Failure is an enormous economic and societal burden worldwide and remains incurable. More than half of heart failure is due to prior myocardial infarction (MI). Whereas death was a common outcome of acute MI in the past, advances in coronary reperfusion technology and adjuvant drug therapy now allow most patients to initially survive their first heart attack, although 35% of these patients progressively develop heart failure over five (5) years. Heart failure patients face a progressive and devastating decline in quality of life that is aggravated by common comorbidities (like obesity, hypertension, and diabetes). The 5-year survival rate is only 50-60%. Today, 50% of Medicare patients admitted to hospital for heart failure die within 3 years of discharge. Because of improved acute care and increased prevalence of risk factors, heart failure due to prior MI is now the single largest cause of human mortality. The incidence of this global disease is predicted to skyrocket in the next few decades -- tripling by 2030. No current therapy, including revascularization, regenerates the lost cardiomyocytes and blood vessels, or effectively prevents progression to heart failure after MI.
Regencor’s proprietary biological, the non-glycosylated recombinant variant of the normal circulating human protein, FSTL1 (ngFSTL1), safely promotes cardiac regeneration after myocardial infarction in multiple rodent and adult pig models. The treatment results in increased animal survival, reduced progression to HF, substantial reduction of scar size, recovery of cardiac function to nearly pre-infarct levels, and the formation of new cardiomyocytes and blood vessels limited exclusively to the infarct zone. The Company has recently shown that infarcted pigs treated with continuous subcutaneous (SubQ) infusion of the protein via osmotic pumps identically stimulates myocardial regeneration, and improves cardiac function and survival. These studies provide proof of principle for the use of commercially available wearable injectors for the outpatient clinical delivery of the protein to patients after MI. This new CIRM award will support IND-enabling studies of ngFSTL1 delivered via SubQ continuous infusion for a single 2–4-week infusion cycle.
“We are grateful to CIRM for their enablement of the next steps in the pre-clinical development of our cardio-regenerative protein, ngFSTL1’” said Thomas Okarma, MD, PhD, Chairman & CEO of Regencor. “We look forward to working with CIRM and our other development partners to help bring this unique cardio-regenerative biological into human testing”.
California’s stem cell agency, the California Institute for Regenerative Medicine, or CIRM, was created by voters in 2004 with the overwhelming passage of Proposotion 71, which authorized $3 billion in funding for stem cell research. It was renewed by voters in 2020 with the passage of Proposotion 14, giving the agency an additional $5.5 billion. At CIRM the mission is to accelerate regenerative treatments to patients with unmet medical needs.
CIRM funds research that may lead to the development of treatments and cures for a wide range of deadly diseases. So far CIRM is working on treatments for 40 different diseases and their funding has led to 68 clinical trials — meaning they have moved out of the lab and are being tested in people. Around 30 other projects that CIRM supported early on have also progressed to clinical trials.