BioCardia, Inc. has announced a significant milestone in its Phase 3 CardiAMP HF II clinical trial with the enrollment of the first patient at University of Wisconsin School of Medicine and Public Health. The enrollment marks progress in the company's pivotal study evaluating an innovative autologous cell therapy for ischemic heart failure patients.
"CardiAMP cell therapy has shown evidence of benefit for ischemic heart failure patients with elevated markers of heart stress, despite being on optimized medical therapy," said Dr. Amish Raval, M.D., Professor of Medicine at UW School of Medicine and Public Health and CardiAMP HF II Trial National Co-Principal Investigator. "We look forward to offering patients the opportunity to participate in this important study and potentially contributing to the evidence that may enable this therapy to be more broadly available."
Phase 3 Trial Design and Objectives
CardiAMP HF II is a 250-patient randomized multicenter procedure placebo-controlled study evaluating CardiAMP autologous cell therapy as a one-time treatment for patients with ischemic heart failure with reduced ejection fraction (HFrEF) on guideline directed medical therapy having elevated NTproBNP. The study is designed to confirm the safety and efficacy results observed in the previous CardiAMP HF study.
The trial employs a three-tier composite primary outcome measure consisting of all cause death, nonfatal major adverse cardiac events, and a validated quality of life measure. In the earlier CardiAMP HF study, this composite efficacy endpoint was achieved with statistical significance in patients with elevated NTproBNP, who are the specific focus of the CardiAMP HF II study.
Therapeutic Advances and Technology
The current trial incorporates several advances in the therapeutic approach, including the use of cell population analysis at screening to define treatment doses and improvements to the Helix system, including the FDA approved Morph DNA steerable platform.
CardiAMP Cell Therapy, which has been granted FDA Breakthrough designation, uses a patient's own bone marrow cells delivered to the heart through a minimally invasive, catheter-based procedure. The therapy is intended to increase capillary density and reduce tissue fibrosis, specifically targeting microvascular dysfunction in heart failure patients.
Clinical Development Support
The CardiAMP Cell Therapy clinical development program for heart failure receives support from the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). The therapy remains limited by United States law to investigational use.
Peter Altman, PhD, CEO of BioCardia, emphasized the significance of the University of Wisconsin partnership: "The leadership of this prestigious cardiology center strengthens our trial. We share the vision of providing specialized medicine that translates into personalized care for improved patient outcomes. Dr. Amish Raval, who has served as our CardiAMP HF II Trial Co-National Principal Investigator since the trial's inception, is a valued world leader in both basic science and translation of biotherapeutic interventions in cardiology."
Company Profile
BioCardia, Inc., headquartered in Sunnyvale, California, positions itself as a global leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary disease treatment. The company's biotherapeutic platforms include CardiAMP autologous and CardiALLO allogeneic cell therapies, with three clinical stage product candidates currently in development. These therapies are supported by the company's Helix biotherapeutic delivery and Morph vascular navigation product platforms.
