Global Heart Failure Consortium led by the Perelman School of Medicine at the University of Pennsylvania and Bristol Myers Squibb publishes data reinforcing potential of PRO-C6 as a promising biomarker for Heart Failure with Preserved Ejection Fraction (HFpEF).
In 2019, researchers at Bristol Myers Squibb and the Perelman School of Medicine at the University of Pennsylvania launched the Global Heart Failure Consortium (GHFC) to accelerate research and advance scientific understanding of this chronic condition. The progress since then has been significant.
Heart failure (HF) is a chronic progressive condition where the heart cannot pump enough blood to meet the body’s oxygen and nutrient needs. There are several types of HF. One of them, heart failure with preserved ejection fraction (HFpEF), makes up about half of the cases. The consortium focuses on identifying HFpEF biomarkers that can assist in diagnosis, monitor disease progression, guide therapy and better characterize the underlying disease pathology. Since the GHFC’s launch, a number of individual and composite biomarkers have emerged from the consortium’s research and multiple biomarker-focused scientific articles have been published.
“The GHFC was created to address unmet medical needs and better support patients who currently have very limited treatment options,” said Julio Chirinos, MD, PhD of Penn’s Perelman School of Medicine, and one of the GHFC’s leaders. “In a relatively short time, this consortium has established itself as a leader in the space of proteomic biomarkers in human heart failure, and has already made important contributions to science.”
Led by Penn and Bristol Myers Squibb, the consortium encompasses 18 medical centers and other study sites in the U.S., Canada, Europe, Japan, India and New Zealand. It also includes industry partners Nordic Bioscience, a Danish company specializing in biomarker technologies; and SomaLogic, a protein biomarker discovery and clinical diagnostics company in the U.S.
One of most promising biomarkers under study is known as PRO-C6, representing the pro-peptide of type VI collagen. Studies have shown that PRO-C6 may be a useful biomarker for the formation of fibrotic tissue and prognostic of negative outcomes in patients with HFpEF. The discovery and development of PRO-C6 as a potential HFpEF biomarker is the result of a collaboration among Penn, Bristol Myers Squibb and Nordic Bioscience.
The consortium published research in NEJM Evidence that further establishes and positions PRO-C6 as a potential biomarker that could be used to help identify patient subgroups for clinical trials and personalized therapies. The research looked at numerous groups of patients with HFpEF from around the world to understand how PRO-C6 may be associated with both the presence of HFpEF and with disease outcomes.
Additionally, important recognition of this biomarker came in 2021 when the U.S. Food and Drug Administration (FDA) issued a Letter of Support to Bristol Myers Squibb, Penn and Nordic Bioscience to urge continued study of PRO-C6 in HFpEF patients. While this doesn’t imply the agency will ultimately approve the biomarker through its formal regulatory process, the Biomarker Qualification Program, it is designed to raise the profile of PRO-C6 in the scientific community and spur more study.
“Identification of efficacious therapies across the broad HFpEF population has been very challenging,” said Francisco Ramirez-Valle, vice president, head of Immunology Thematic Research Center (I TRC), and Immunology, Cardiovascular & Fibrosis Translational Early Development, Bristol Myers Squibb, and a consortium leader. “Many large clinical trials have failed to meet their primary endpoints due to the lack of validated patient stratification approaches to match the therapy to the underlying pathology.”
“The letter of support from the FDA is powerful validation of the need for serum biomarker tools such as PRO-C6 for use in development of new therapies for HFpEF,” added David Gordon, vice president, Cardiovascular & Fibrosis Discovery Biology, Bristol Myers Squibb, also a GHFC leader. “Based on the robust data with this biomarker, there is also a genuine potential that PRO-C6 will be used in routine cardiology practice to assess individual patient risk and prognosis and perhaps guide therapy.”
GHFC’s leadership team also includes Thomas P. Cappola, MD, chief of Cardiovascular Medicine at PennMedicine; and Lei Zhao, senior director, Cardiovascular & Fibrosis Translational Research, Bristol Myers Squibb; with support from Karl Kammerhoff, GHFC Program Manager, Global Biospecimen & Imaging Management, Bristol Myers Squibb. Dr. Chirinos receives compensation as a Bristol Myers Squibb consultant.
This article originally posted on February 07, 2020, and was most recently updated on September 13, 2022.
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