Secretome Therapeutics Initiates Phase 1 Clinical Trial of STM-01 in Patients with Dilated Cardiomyopathy

PLANO, Texas--(BUSINESS WIRE)--Secretome Therapeutics today announced the launch of a Phase 1, dose-escalating trial of STM-01, Secretome’s neonatal cardiac progenitor cell (nCPC) product, for the treatment of heart failure in young adults with dilated cardiomyopathy (DCM). This trial, and a subsequent dose-escalating Phase 1 of STM-01 in pediatric DCM, are funded through a grant from The Marcus Foundation and will take place at Children’s Healthcare of Atlanta.

Pediatric DCM is a rare but life-threatening form of heart failure that affects between 500 and 1,000 children in the United States. The disease is diagnosed on average at 2 years of age, and without heart transplantation, life expectancy is 5 years after diagnosis on average. Preclinical studies conducted in the laboratories of Michael Davis, Ph.D. at Emory University and Georgia Tech, and Sunjay Kaushal, M.D., Ph.D. at the University of Maryland, Baltimore indicate that nCPC produce marked improvements in cardiac function in both adult and juvenile animal models of heart failure.

“Our preclinical published results in animals suggest that, compared to mesenchymal stem cells from older donors, STM-01 is uniquely potent at improving ejection fraction and treating heart failure,” said Michael Davis, Ph.D., Director of the Emory and Children’s Heart Research and Outcomes Center and Professor of Cardiology and Biomedical Engineering at the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. “We are grateful for the support from The Marcus Foundation to now study this potentially groundbreaking new therapy in adults and children with DCM who truly need a new treatment option.”

The Phase 1 trial in adult patients with DCM will study the safety of multiple ascending doses of STM-01. If safe and well-tolerated, STM-01 will proceed to a Phase 1 multiple ascending dose study in pDCM. Both trials will occur at the Marcus Center for Cellular Therapy at Children's Arthur M. Blank Hospital.

“The launch of this clinical study is the first step towards offering a new class of therapies to adult and pediatric patients suffering from DCM,” said Vinny Jindal, President and Chief Executive Officer of Secretome Therapeutics. “We are honored to work with the teams at Children’s, Emory, and The Marcus Foundation to study STM-01 in this lethal and underserved disease.”

About The Marcus Foundation

Founded in 1989, The Marcus Foundation fulfills the philanthropic vision of the late Bernie Marcus, co-founder of The Home Depot, and his wife, Billi Marcus. The Foundation’s grantmaking philosophy is derived from Bernie Marcus’ personal life experiences as a businessman and entrepreneur. Upholding Bernie’s beliefs and values in entrepreneurial philanthropy, the Foundation has five key areas of giving – all with the goal to transform lives through innovative problem solving. The five focus areas are: medical research and healthcare; Jewish causes; free enterprise, including veteran initiatives and national security; the health and welfare of children, with an emphasis on civics education; and targeted community support. The Foundation has given more than $2.7 billion in grants in the past 30+ years.

About Secretome Therapeutics

Secretome Therapeutics is a clinical-stage biotechnology company based in Plano, Texas, developing novel therapies derived from neonatal cardiac progenitor cells (nCPCs). Our lead product, STM-01, is a first-in-class cellular therapy designed to modulate inflammatory and fibrotic pathways and support myocardial function in dilated cardiomyopathy (DCM) and heart failure with preserved ejection fraction (HFpEF). Additionally, Secretome Therapeutics is advancing STM-21, a secretome-based therapeutic currently in preclinical development for inflammatory conditions, including skin wounds and diabetes-associated co-morbidities.