STM-01 / Secretome Therapeutics - LARVOL DELTA

Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Secretome Therapeutics | N=18 ➔ 12

Enrollment change • Cardiovascular • Congestive Heart Failure • Heart Failure

Study in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Secretome Therapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2024 ➔ Mar 2025 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Enrollment open • Trial initiation date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Secretome Therapeutics Announces First Patient Dosed in Groundbreaking Phase 1 Study of STM-01 in Heart Failure with Preserved Ejection Fraction (Businesswire) - "Secretome Therapeutics...announced dosing of the first patient in its Phase 1 clinical trial evaluating STM-01 as a treatment for heart failure with preserved ejection fraction (HFpEF)...This is the first-ever clinical study of an allogeneic, off-the-shelf stem cell therapy in HFpEF, a leading cause of hospitalization, morbidity, and mortality worldwide...The Phase 1 clinical trial is a first-in-human, multiple-ascending dose, open-label study designed to assess the safety, tolerability, and exploratory efficacy of STM-01 in patients diagnosed with HFpEF. Patients will receive either 100 million or 200 million nCPC infused intravenously over one hour. The first patient was enrolled at The University of Texas, Southwestern Medical Center (UTSW), under the care of Dr. Ambarish Pandey, Associate Professor of Internal Medicine at UTSW."

Trial status • Heart Failure

Secretome Therapeutics Granted FDA Fast Track Designation for STM-01, a Neonatal Cardiac Progenitor Cell Therapy for HFpEF (Businesswire) - "Secretome Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STM-01, the company’s neonatal cardiac progenitor cell (nCPC) therapy, for the treatment of Heart Failure with Preserved Ejection Fraction (HFpEF)....With this designation, Secretome Therapeutics will benefit from increased interactions with the FDA, including the potential for priority review and a rolling submission of its Biologics License Application (BLA) for STM-01."

Fast track • Cardiovascular • Heart Failure

Secretome Therapeutics Closes $20.4 Million Financing Round to Advance Cardiomyopathy and Heart Failure Therapies (Businesswire, Businesswire) - "Secretome Therapeutics...today announced the successful closing of a $20.4 million round of financing. This funding will enable Secretome to initiate clinical trials for its lead asset, STM-01, and further advance its innovative pipeline....Secretome plans to initiate two multiple-ascending dose Phase 1 trials of STM-01 by the end of 2024: The first trial, led by Dr. Sanjiv Shah...will evaluate STM-01 in patients with HFpEF."

Grant

Secretome Therapeutics Closes $20.4 Million Financing Round to Advance Cardiomyopathy and Heart Failure Therapies (Businesswire, Businesswire) - "Secretome Therapeutics...today announced the successful closing of a $20.4 million round of financing. This funding will enable Secretome to initiate clinical trials for its lead asset, STM-01, and further advance its innovative pipeline....Secretome plans to initiate two multiple-ascending dose Phase 1 trials of STM-01 by the end of 2024: The first trial, led by Dr. Sanjiv Shah...will evaluate STM-01 in patients with HFpEF."

Grant