NeoProgen receives approval from U.S. FDA for a Phase I Study of The Safety And Early Efficacy of Intravenous Allogeneic Neonatal Mesenchymal Cells (nMSCs) In Chronic Ischemic Heart Failure
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."
“This is another major milestone for NeoProgen”, said Bill Niland, who has successfully founded and exited three previous healthcare companies.
"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, JNiland@NeoProgen.com
April 13, 2021
BALTIMORE--(BUSINESS WIRE)--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 a patent from the United States Patent Office Patent No.: US 10.967,007 B2 “Cardiac Stem Cells for Cardiac Repair”. The innovation was developed by Dr. Sunjay Kaushal, a pediatric cardiac surgeon, while he was at the University of Maryland, Baltimore and NeoProgen is the exclusive licensee of the newly issued patent.
Oct. 27, 2020
In 2020, The Maryland Stem Cell Research Commission (The Commission) announced $8.3M MSRCF grant awards across two funding rounds. MSCRF has awarded $157M in funding to BHCR companies seeking to accelerate stem cell research, therapies, and commercialization of products since 2007. Recent MSCRF funding recipients include Frederick, Maryland’s RoosterBio, Inc., Theradaptive, and Baltimore’s Neoprogen.
Oct. 17, 2019
NeoProgen, a Baltimore-based company led by medtech entrepreneur Bill Niland, raised $1.5 million in seed funding as it develops a cell therapy for patients following a heart attack.
October 16, 2019
NeoProgen, Inc., a preclinical stage therapeutics company located in Baltimore, has received a $245,000 investment from the University System of Maryland (USM) Maryland Momentum Fund to complete the company’s $1.5M seed funding round, which also includes participation from UMB, TEDCO (Maryland Venture Partners, L.P.) and UM Ventures.
September 10, 2019
The MSCRF awards of the 2020 fiscal year include:
Jun 27, 2019
Bill Niland has led multiple medical device companies throughout his career, and was the CEO behind the $250 million sale of Baltimore's Harpoon Medical in 2017. Now, he is working to build three more device companies here, with hopes to lead all of them through similar exits.