Patient Enrollment Commenced in Pivotal Phase 3 Trial of CardiAMP Cell Therapy for the Treatment of Ischemic Heart Failure
BioCardia [Nasdaq: BCDA] has initiated patient enrollment for its pivotal Phase 3 trial of CardiAMP Cell Therapy, targeting ischemic heart failure with reduced ejection fraction (HFrEF). The 250-patient randomized, controlled trial aligns with FDA guidelines and features a 12-month primary composite endpoint. CardiAMP has received Breakthrough Device Designation from the FDA, potentially expediting development and review processes.
Dr. Leslie Miller, a trial investigator, emphasized the therapy's potential to be groundbreaking for heart failure patients. BioCardia CEO Peter Altman expressed optimism about swift enrollment and the therapy's potential to enhance survival, reduce adverse events, and improve quality of life, addressing a significant need in ischemic heart failure treatment.
BioCardia [Nasdaq: BCDA] ha avviato l'arruolamento dei pazienti per il suo trial della fase 3, cruciale per la terapia cellulare CardiAMP, destinata al trattamento dell'insufficienza cardiaca ischemica con frazione di eiezione ridotta (HFrEF). Il trial controllato e randomizzato su 250 pazienti è in linea con le linee guida della FDA e prevede un endpoint composito primario di 12 mesi. CardiAMP ha ricevuto la designazione di Dispositivo Innovativo dalla FDA, il che potrebbe accelerare i processi di sviluppo e revisione.
Il Dr. Leslie Miller, investigatore del trial, ha sottolineato il potenziale della terapia di essere rivoluzionaria per i pazienti con insufficienza cardiaca. Il CEO di BioCardia, Peter Altman, ha espresso ottimismo riguardo un arruolamento rapido e al potenziale della terapia di migliorare la sopravvivenza, ridurre eventi avversi e migliorare la qualità della vita, rispondendo a un bisogno significativo nel trattamento dell'insufficienza cardiaca ischemica.
BioCardia [Nasdaq: BCDA] ha iniciado el reclutamiento de pacientes para su ensayo pivotal de fase 3 de Terapia Celular CardiAMP, dirigida a la insuficiencia cardiaca isquémica con fracción de eyección reducida (HFrEF). El ensayo controlado y aleatorizado de 250 pacientes se alinea con las directrices de la FDA y presenta un punto final compuesto primario de 12 meses. CardiAMP ha recibido la designación de Dispositivo Innovador por parte de la FDA, lo que podría acelerar el desarrollo y los procesos de revisión.
El Dr. Leslie Miller, investigador del ensayo, destacó el potencial de la terapia para ser revolucionaria para los pacientes con insufficiencia cardíaca. El CEO de BioCardia, Peter Altman, expresó optimismo sobre un rápido reclutamiento y el potencial de la terapia para mejorar la supervivencia, reducir eventos adversos y mejorar la calidad de vida, abordando una necesidad significativa en el tratamiento de la insuficiencia cardiaca isquémica.
BioCardia [Nasdaq: BCDA]는 감소된 박출 분율(HFrEF)을 동반한 허혈성 심부전 치료를 위한 CardiAMP 세포 치료의 중요한 3상 시험을 위해 환자 등록을 시작했습니다. 250명의 환자에 대한 무작위 대조 시험은 FDA 가이드라인을 따르며 12개월의 주요 복합 결과 지표를 특징으로 합니다. CardiAMP는 FDA로부터 혁신적 장치 지정을 받아 개발 및 검토 과정을 가속화할 수 있습니다.
시험 연구자인 Leslie Miller 박사는 이 치료가 심부전 환자에게 혁신적일 수 있는 잠재력을 강조했습니다. BioCardia의 CEO인 Peter Altman은 신속한 환자 등록과 치료가 생존율 향상, 부작용 감소, 삶의 질 향상이라는 잠재력을 가지고 있으며, 허혈성 심부전 치료에서 중요한 필요를 충족할 수 있다고 낙관했습니다.
BioCardia [Nasdaq: BCDA] a lancé le recrutement des patients pour son essai pivot de phase 3 de la thérapie cellulaire CardiAMP, visant à traiter l'insuffisance cardiaque ischémique avec fraction d'éjection réduite (HFrEF). L'essai contrôlé randomisé de 250 patients est conforme aux directives de la FDA et présente un critère d'évaluation composite principal sur 12 mois. CardiAMP a reçu la dénomination de Dispositif Innovant de la FDA, ce qui pourrait accélérer les processus de développement et d'examen.
Le Dr. Leslie Miller, chercheur de l'essai, a souligné le potentiel de la thérapie pour être révolutionnaire pour les patients souffrant d'insuffisance cardiaque. Peter Altman, PDG de BioCardia, s'est montré optimiste quant à un recrutement rapide et au potentiel de la thérapie d'améliorer la survie, de réduire les événements indésirables et d'améliorer la qualité de vie, répondant ainsi à un besoin important dans le traitement de l'insuffisance cardiaque ischémique.
BioCardia [Nasdaq: BCDA] hat die Patienteneinschreibung für seine entscheidende Phase-3-Studie zur CardiAMP-Stammzelltherapie gestartet, die auf ischämische Herzinsuffizienz mit reduzierter Ejektionsfraktion (HFrEF) abzielt. Die 250-Patienten randomisierte, kontrollierte Studie entspricht den FDA-Richtlinien und weist einen primären, zusammengesetzten Endpunkt über 12 Monate auf. CardiAMP hat von der FDA die Breakthrough Device Designation erhalten, was möglicherweise die Entwicklungs- und Überprüfungsprozesse beschleunigt.
Dr. Leslie Miller, ein Studienleiter, betonte das Potenzial der Therapie, bahnbrechend für Herzinsuffizienzpatienten zu sein. Der CEO von BioCardia, Peter Altman, äußerte Optimismus über eine schnelle Einschreibung und das Potenzial der Therapie, die Überlebensrate zu erhöhen, unerwünschte Ereignisse zu reduzieren und die Lebensqualität zu verbessern, um ein signifikantes Bedürfnis in der Behandlung der ischämischen Herzinsuffizienz zu adressieren.
- Commencement of patient enrollment in pivotal Phase 3 trial for CardiAMP Cell Therapy
- FDA granted Breakthrough Device Designation for CardiAMP Cell Therapy
- Alignment with FDA on trial design and endpoints
- Potential for expedited development and prioritized review due to Breakthrough Designation
- Strong interest from potential trial participants, with nine patients already in active screening
- None.
Insights
The commencement of patient enrollment in BioCardia's pivotal Phase 3 trial for CardiAMP Cell Therapy marks a significant milestone in the development of treatments for ischemic heart failure. This trial, involving 250 patients, aims to evaluate the efficacy of an autologous cell therapy in addressing a critical unmet need in cardiovascular medicine.
The trial's primary endpoint, a composite of all-cause death, reduction in major adverse cardiovascular events and improvement in quality of life, is comprehensive and patient-centric. This approach aligns with the FDA's increasing focus on patient-reported outcomes and real-world benefits. The 12-month follow-up period is substantial, allowing for a robust assessment of the therapy's durability and long-term impact.
The FDA's Breakthrough Device Designation for CardiAMP Cell Therapy is particularly noteworthy. This designation not only highlights the potential significance of this treatment but also suggests a smoother regulatory pathway, potentially accelerating its time to market if the trial results are positive.
However, it's important to temper enthusiasm with caution. While previous studies have shown promising trends, Phase 3 trials often reveal challenges not apparent in earlier stages. The complexity of autologous cell therapies, including potential variability in cell quality and the logistics of personalized treatments, could pose hurdles in demonstrating consistent efficacy across a larger patient population.
BioCardia's advancement to a Phase 3 trial for its CardiAMP Cell Therapy represents a significant value inflection point for the company. As a
The ischemic heart failure market is substantial, with millions of patients worldwide and effective treatment options. A successful cell therapy in this space could potentially capture a multi-billion dollar market. However, investors should be mindful of the capital-intensive nature of late-stage clinical trials, especially for a small-cap biotech company. BioCardia will likely need to secure additional funding to support this trial through to completion, which could lead to dilution for existing shareholders.
The Breakthrough Device Designation is a significant regulatory advantage, potentially reducing time and costs associated with the approval process. This could accelerate BioCardia's path to commercialization if the trial results are positive, providing a competitive edge in the rapidly evolving cell therapy landscape.
While the news is undoubtedly positive for BioCardia's prospects, it's important to note that the company's future hinges heavily on the success of this single asset. This concentration of risk is typical for small biotech companies but requires careful consideration from investors. The trial's outcome will be a binary event for BioCardia's stock, with potential for significant upside in case of success, but also substantial downside risk in case of failure.
SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF) has commenced enrollment in the United States.
BioCardia previously confirmed alignment with the United States Food and Drug Administration (FDA) on the design of the 250-patient randomized, controlled trial and the minimum of 12-month primary composite endpoint of all cause death, reduction in major adverse cardiovascular events, and improvement in quality of life. FDA granted CardiAMP Cell Therapy a Breakthrough Device Designation for the treatment of ischemic heart failure. Breakthrough designation provides for FDA to expedite development and prioritize review of regulatory submissions intended to help patients have more timely access to these product candidates.
“The CardiAMP cell therapy has the potential to be groundbreaking and life changing for patients with heart failure,” said Dr. Leslie Miller, MD, 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. “As the principal investigator of the first site activated to enroll patients in this important study, I have identified many patients who may benefit from inclusion in this clinical trial, including nine patients in my clinic in active screening to participate after meeting the important NTproBNP inclusion criterion.”
BioCardia Chief Executive Officer, Peter Altman, PhD said “We are looking forward to expeditious enrollment in the trial ahead working with world class clinical heart function teams with the objective of confirming the trends of enhanced survival, reduced major adverse events, and improved quality of life observed in previous studies. There is a significant need for a safe, effective, and durable treatment for patients with ischemic heart failure, in particular one that positively impacts patient survival and quality of life.”
About Chronic Heart Failure of Reduced Ejection Fraction (HFrEF)
Heart failure of reduced ejection fraction (HFrEF) is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2022, the American Heart Association report on heart disease statistics estimated that 3 million American adults ages 20 and older have heart failure of reduced ejection fraction with a prevalence expected to increase to more than 4 million people by 2030. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart’s ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body’s needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living.
Despite guideline-directed therapies employing a wide range of pharmacologic, device, and surgical options, many patients deteriorate over time and develop advanced heart failure symptoms that cannot be effectively managed by existing medical therapies.
About CardiAMP Cell Therapy
Granted Breakthrough Designation by the FDA, the CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. Clinical development to date in randomized controlled double blinded trials has shown trends towards enhanced patient survival, reduced major adverse cardiac events, and improved quality of life. The CardiAMP clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Center for Medicare and Medicaid Services (CMS) for both treatment and control procedures. CAUTION - Limited by United States law to investigational use.
About CardiAMP Heart Failure Clinical Development
BioCardia expects final study results from the randomized double blinded controlled one hundred and twenty-five subjects CardiAMP Heart Failure I Study in November 2024. Interim results demonstrated a
The confirmatory CardiAMP Heart Failure II study focuses on patients in active heart failure who demonstrated the greatest benefits in the interim results of the CardiAMP Heart Failure I study. This subgroup of patients showed strong signals of benefit with
The CardiAMP Heart Failure II study also uses a validated quality of life patient self-assessment instrument as the third component of the primary endpoint instead of the distance walked in six minutes. This endpoint would have been statistically significant in the patients with active heart failure that are the focus of the CardiAMP Heart Failure II study (p=0.03). The study design has >
The world class cardiologists who comprise the Co-National principal investigators, Executive Steering Committee Members, Clinical Events Committee and the Data Safety Monitoring Board from the CardiAMP Heart Failure I study are all continuing with the CardiAMP Heart Failure II study with world class additions. Many clinical sites are in active stages of being onboarded and activated.
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information visit: www.BioCardia.com.
Forward Looking Statements:
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the potential benefits of CardiAMP cell therapy for patients with ischemic HFrEF, and the rate of enrollment in clinical trials ahead. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” And in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
FAQ
What is the purpose of BioCardia's Phase 3 trial for CardiAMP Cell Therapy?
What is the primary endpoint of BioCardia's CardiAMP Cell Therapy Phase 3 trial?
Has BioCardia's CardiAMP Cell Therapy received any special designations from the FDA?
How many patients are expected to be enrolled in BioCardia's CardiAMP Cell Therapy Phase 3 trial?
What potential benefits does BioCardia (BCDA) expect from CardiAMP Cell Therapy for heart failure patients?
