Patient Enrollment Begins in Phase 3 Trial of CardiAMP Cell Therapy for Ischemic Heart Failure

SUNNYVALE, CA, USA I July 25, 2024, BioCardia, Inc. [Nasdaq: BCDA], a prominent entity in cellular and cell-derived therapies for cardiovascular and pulmonary disorders, has announced the initiation of patient enrollment in the United States for its Phase 3 trial. The trial will investigate the efficacy of the CardiAMP cell therapy product for patients with ischemic heart failure with reduced ejection fraction (HFrEF).

The trial design, which involves 250 patients and runs over a minimum duration of 12 months, has been approved by the United States Food and Drug Administration (FDA). The primary outcomes to be measured include overall mortality, reduction in major adverse cardiovascular events, and improvements in quality of life. The FDA has granted CardiAMP Cell Therapy a Breakthrough Device Designation, facilitating faster development and prioritized review processes, aimed at providing patients with quicker access to the therapy.

Dr. Leslie Miller, MD, a trial investigator at the CHF Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida, and a member of the CardiAMP Heart Failure II Study Executive Steering Committee, stated, "The CardiAMP cell therapy holds transformative potential for heart failure patients. We've already identified numerous candidates who may benefit from inclusion in this essential study, including nine patients currently under active screening."

Peter Altman, PhD, BioCardia's CEO, expressed optimism about the trial's progress, noting, "We anticipate rapid enrollment and look forward to confirming the positive trends in survival, reduced adverse events, and improved quality of life observed in earlier studies. The need for an effective, durable, and safe treatment for ischemic heart failure remains critical."

HFrEF is a condition where the heart's ability to pump blood diminishes, failing to meet the body's metabolic needs. The American Heart Association reported in 2022 that roughly 3 million American adults suffer from HFrEF, with numbers expected to climb to over 4 million by 2030. As heart failure progresses, the heart's capacity to respond to increased metabolic demands wanes, eventually incapacitating the patient. Current treatments, despite being comprehensive, often fail to manage advanced symptoms effectively.

CardiAMP Cell Therapy, which has received Breakthrough Designation from the FDA, utilizes a patient’s bone marrow cells, delivered via a minimally invasive, catheter-based procedure. This method aims to trigger the heart's natural healing processes. The therapy includes three unique elements: pre-procedural cell analysis for patient selection, a high target cell dosage, and a proprietary delivery system proven to be safer and more effective in retaining cells than other methods. Previous clinical trials have shown promising trends in patient survival and quality of life improvements. The development of CardiAMP for heart failure is also supported by the Maryland Stem Cell Research Fund and is reimbursed by Center for Medicare and Medicaid Services (CMS).

The CardiAMP Heart Failure II study, a confirmatory trial, focuses on patients in active heart failure who showed the greatest benefits in earlier studies. This group exhibited a significant reduction in mortality and near-statistical significance in primary outcomes over two years. The study employs a validated quality of life assessment tool as part of its primary endpoint, which would have been statistically significant in the targeted patient group. The study design boasts a high probability of achieving statistical significance based on interim results.

Renowned cardiologists from the CardiAMP Heart Failure I study are continuing their efforts in the CardiAMP Heart Failure II study, with additional expert members joining the team. Numerous clinical sites are currently being activated to participate in this significant trial.

BioCardia, Inc., based in Sunnyvale, California, is a leader in cellular and cell-derived therapies for cardiovascular and pulmonary diseases. Their product platforms include CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, both in advanced clinical development stages. These therapies are supported by BioCardia’s Helix™ biotherapeutic delivery and Morph® vascular navigation platforms.

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