FDA Approves CardiAMP® Heart Failure II Protocol Amendment to Use Proprietary Cell Population Analysis Screening to Define Treatment
BioCardia BCDA announced FDA approval for a protocol amendment in its CardiAMP Heart Failure II Trial, a Phase 3 study of autologous cell therapy for ischemic heart failure. The amendment allows for personalized treatment plans based on the proprietary CardiAMP Cell Population Analysis, enabling patients previously excluded to receive additional cell deliveries to achieve the target minimum dosage.
This advancement, built on data from 125 patients in the CardiAMP Heart Failure I Trial, is expected to enhance clinical experience and expand market opportunity. The refined approach adjusts dosing aliquots for patients with lower concentrations of specified cells, potentially increasing patient eligibility for the trial significantly.
BioCardia BCDA ha annunciato l'approvazione della FDA per un emendamento del protocollo nella sua CardiAMP Heart Failure II Trial, uno studio di Fase 3 sulla terapia cellulare autologa per l'insufficienza cardiaca ischemica. L'emendamento consente la creazione di piani di trattamento personalizzati basati sull'analisi della popolazione cellulare CardiAMP, permettendo ai pazienti precedentemente esclusi di ricevere ulteriori somministrazioni di cellule per raggiungere il dosaggio minimo target.
Questo progresso, basato su dati di 125 pazienti della CardiAMP Heart Failure I Trial, si prevede che possa migliorare l'esperienza clinica e espandere le opportunità di mercato. L'approccio affinato regola le aliquote di dosaggio per i pazienti con basse concentrazioni di cellule specifiche, aumentando potenzialmente l'idoneità dei pazienti per lo studio in modo significativo.
BioCardia BCDA anunció la aprobación de la FDA para una enmienda del protocolo en su CardiAMP Heart Failure II Trial, un estudio de Fase 3 sobre terapia celular autóloga para la insuficiencia cardíaca isquémica. La enmienda permite planes de tratamiento personalizados basados en el análisis de población celular CardiAMP, lo que permite que pacientes previamente excluidos reciban entregas adicionales de células para alcanzar la dosis mínima objetivo.
Este avance, basado en datos de 125 pacientes en la CardiAMP Heart Failure I Trial, se espera que mejore la experiencia clínica y amplíe las oportunidades de mercado. El enfoque refinado ajusta las alícuotas de dosificación para pacientes con bajas concentraciones de células específicas, lo que podría aumentar significativamente la elegibilidad de los pacientes para el ensayo.
BioCardia BCDA는 자가 세포 치료를 위한 심부전 이식 생체 세포 연구 CardiAMP Heart Failure II Trial의 프로토콜 수정에 대한 FDA 승인을 발표했습니다. 이 수정은 개인 맞춤 치료 계획을 가능하게 하여 CardiAMP 세포 집단 분석을 기반으로 하며, 이전에 제외된 환자들이 목표 최소 용량을 달성하기 위해 추가 세포 주입을 받을 수 있도록 허용합니다.
이 발전은 CardiAMP Heart Failure I Trial의 125명의 환자 데이터를 바탕으로 이루어졌으며, 임상 경험을 향상시키고 시장 기회를 확대할 것으로 기대됩니다. 정교해진 접근법은 특정 세포의 농도가 낮은 환자를 위한 용량 알리콧을 조정하여, trial에 대한 환자의 적합성을 상당히 증가시킬 수 있습니다.
BioCardia BCDA a annoncé l'approbation de la FDA pour une modification de protocole dans son CardiAMP Heart Failure II Trial, une étude de Phase 3 sur la thérapie cellulaire autologue pour l'insuffisance cardiaque ischémique. La modification permet de créer des plans de traitement personnalisés basés sur l'analyse de la population cellulaire CardiAMP, permettant ainsi aux patients précédemment exclus de recevoir des livraisons de cellules supplémentaires pour atteindre la dose minimale ciblée.
Ce progrès, fondé sur les données de 125 patients dans la CardiAMP Heart Failure I Trial, devrait améliorer l'expérience clinique et élargir les opportunités sur le marché. L'approche affinée ajuste les aliquotes de dosage pour les patients ayant de faibles concentrations de cellules spécifiques, ce qui pourrait augmenter considérablement l'éligibilité des patients pour l'essai.
BioCardia BCDA hat die FDA-Zulassung für eine Protokolländerung in seiner CardiAMP Heart Failure II Trial bekannt gegeben, einer Phase-3-Studie zur autologen Zelltherapie bei ischämischer Herzinsuffizienz. Die Änderung ermöglicht personalisiert angepasste Behandlungspläne basierend auf der proprietären CardiAMP Zellpopulation-Analyse, sodass zuvor ausgeschlossene Patienten zusätzliche Zellübertragungen erhalten können, um die Mindestdosierung zu erreichen.
Dieser Fortschritt, der auf Daten von 125 Patienten in der CardiAMP Heart Failure I Trial basiert, soll die klinische Erfahrung verbessern und Marktchancen erweitern. Der verfeinerte Ansatz passt die Dosierungsaliquote für Patienten mit niedrigen Konzentrationen von bestimmten Zellen an, was die Eignung der Patienten für die Studie erheblich erhöhen könnte.
- FDA approval for protocol amendment in CardiAMP Heart Failure II Trial
- Personalized treatment plans based on proprietary Cell Population Analysis
- Potential increase in patient eligibility for the trial
- Enhanced clinical experience and expanded market opportunity
- None.
Insights
The FDA's approval of BioCardia's protocol amendment for the CardiAMP Heart Failure II Trial represents a significant advancement in personalized medicine for cardiovascular treatments. This modification allows for a more inclusive patient selection process and tailored dosing strategies based on individual cell compositions. The proprietary Cell Population Analysis screening method is a novel approach that could potentially improve treatment efficacy and expand the eligible patient pool.
From a clinical perspective, this amendment addresses a important challenge in autologous cell therapies: variability in patient cell populations. By adjusting dosing based on each patient's unique cell profile, BioCardia may enhance the therapy's consistency and effectiveness. This personalized approach could lead to better patient outcomes and provide valuable data for future cell therapy developments in cardiovascular medicine.
The FDA's approval of BioCardia's protocol amendment could have positive financial implications for the company. By potentially increasing the number of eligible patients for the CardiAMP Heart Failure II Trial, BioCardia may accelerate its clinical progress and expand its market opportunity. This could lead to:
- Faster patient enrollment, potentially reducing trial costs and time to market
- Increased chances of successful trial outcomes, boosting investor confidence
- A wider addressable market upon potential approval, enhancing revenue prospects
However, investors should note that while this development is promising, it doesn't guarantee trial success or FDA approval. The financial impact will ultimately depend on the therapy's efficacy and safety profile in the expanded patient population.
- Patented personalized medicine approach for patient dosing for autologous cell therapy
- Expected to meaningfully enhance clinical experience and market opportunity
SUNNYVALE, Calif., Aug. 21, 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 FDA has approved a protocol amendment for the CardiAMP Heart Failure II Trial, BioCardia’s confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF). The protocol amendment allows patients who would have previously been excluded from treatment to receive additional cell deliveries to achieve the same target minimum dosage utilizing a treatment plan informed by the preprocedural CardiAMP Cell Population Analysis.
“This is a substantial advance in autologous cell therapy built on the analysis of clinical data from the 125 patients enrolled in our CardiAMP Heart Failure I Trial,” said Debby Holmes-Higgin, Vice President of Clinical at BioCardia. “This modification is expected to enable the same dosing result to be achieved for more patients and enhance the ease, efficiency, and experience for patients, physicians, and coordinators, in the CardiAMP Heart Failure II Trial.”
The CardiAMP Cell Population Analysis approach was developed to select patients most likely to respond to therapy based on their therapeutic cell composition at screening. In the CardiAMP Heart Failure II Trial, available clinical results enabled both refinement of the algorithm and development of a personalized treatment plan for patients below the Cell Population Analysis acceptance criteria. Such treatment plans adjust the number of dosing aliquots for patients with lower concentrations of important specified cells. Combined, the algorithm modifications and development of the treatment plan approach are expected to considerably increase the number of patients eligible for the trial.
About CardiAMP Cell Therapy
Designated by the FDA as a Breakthrough Therapy, 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 population analysis for patient selection and treatment planning, 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 the 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 Trial in November 2024. Interim results demonstrated a
The confirmatory CardiAMP Heart Failure II Trial focuses on patients in active heart failure who demonstrated the greatest benefits in the interim results of the CardiAMP Heart Failure I Trial. This subgroup of patients showed strong signals of benefit with
The CardiAMP Heart Failure II Trial 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 Trial (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 Trial are all continuing with the CardiAMP Heart Failure II Trial with world class additions. Many clinical sites are in active stages or 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, the expected impacts from the protocol amendments 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.
Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
FAQ
What is the purpose of the FDA-approved protocol amendment for BioCardia's BCDA CardiAMP Heart Failure II Trial?
How does the CardiAMP Cell Population Analysis benefit the CardiAMP Heart Failure II Trial for BCDA?
What impact is expected from the protocol amendment on BioCardia's BCDA market opportunity?
How many patients' data was used to develop the CardiAMP Cell Population Analysis for BCDA's heart failure trial?
