BALTIMORE, MD., June 10, 2021 —
NeoProgen, Inc., a pre-clinical stage company developing an exosome-based product from human neonatal heart-derived Medicinal Signaling Cells (nMSCs) for tissue repair and regeneration for the treatment of heart failure (HF) and other inflammatory diseases, announced that it has received approval from the United States Food and Drug Administration (FDA) to begin a Phase 1 trial, Study of The Safety And Efficacy of Intravenous Allogeneic Neonatal Mesenchymal Cells (nMSCs) In Chronic Ischemic Heart Failure an indication that is the leading cause of death in the United States.
NeoProgen is sponsoring the Phase 1 trial on NEO2001, a therapeutic derived from neonatal heart tissue. NeoProgen owns the exclusive rights to No.: US 10.967,007 B2 “Cardiac Stem Cells for Cardiac Repair.
“We are very pleased that NeoProgen’s first IND has been favorably reviewed ” said Dr. Sunjay Kaushal, MD, Chief Medical Officer of NeoProgen. “Our Phase 1 study design provides us the opportunity to gain important insights about the effectiveness of NEO2001 for a wide range of Heart Failure disease symptoms and signs.”
“Our Phase 1 study design provides us the opportunity to gain important insights about the effectiveness of NEO2001 for a wide range of Heart Failure disease symptoms and signs.”
“This is another major milestone for NeoProgen”, said Bill Niland, the company’s CEO who has successfully founded and exited three previous healthcare companies. “In addition to expanding our patent portfolio, this patent gives us coverage of our #1 asset: a secretome /exosome product that we expect to get into a phase 1 trial this year for Ischemic Cardiomyopathy, where we have excellent pre-clinical results”.
“The hypoallergenic and exceptional safety profile observed in preclinical studies, make nMSCs the best cell therapy candidate” said Dr. Sudhish Sharma, PhD, Chief Techological Officer of NeoProgen. “We are hopeful that the superb anti-inflammatory and pro-angiogenic properties of nMSCs will benefit the large population of patients suffering with chronic heart failure.”
Product NEO2001 is an allogenic culture-expanded neonatal mesenchymal stem cell (nMSCs) formulation that possesses unique and powerful immunomodulatory effect with a strong effectiveness to block the cytokine storm. nMSCs are isolated from the right appendage of neonatal donors with normal myocardium undergoing congenital heart surgery. Clinical experience with MSC derived from adult patients (adult mesenchymal stem cells (aMSCs)) in cardiac patients suggest potential benefit by improvement in cardiac function and attenuation of left ventricle remodeling. nMSCs possess the same biological properties as aMSCs which are critical for maintaining the safety, immunogenicity, toxicity, and pharmacokinetic properties seen with aMSCs. However, our preclinical studies show that nMSCs are more potent than aMSCs in all the assessed parameters (including induction of angiogenesis, cardiogenesis, anti-inflammatory properties, immune-modulation, and reduction in cardiac fibrosis, oxidative stress and apoptosis) by at least 5- to 10-fold due to a more prolific secretome. The proposed clinical trial will evaluate the safety and efficacy of NEO2001 for the treatment of patients with ischemic myocardium. nMSCs or NEO2001 are used interchangeably throughout the reports as nMSCs are the functional unit of NEO2001.
NeoProgen, Inc., is a pre-clinical stage company developing human neonatal heart-derived Medicinal Signaling Cells (nMSCs) and an exosome-based product for tissue repair and regeneration for the treatment of heart failure (HF) and other inflammatory diseases. Contact: Jamie Niland, [email protected]