Benzinga | Jun 22, 2021 08:03AM EDT

BioCardia To Present CardiAMP Cell Therapy Clinical Trial Data At European Society Of Cardiology Heart Failure 2021

BioCardia(r), Inc. (NASDAQ:BCDA), a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces data from its CardiAMP Cell Therapy Heart Failure pivotal trial (ClinicalTrials.gov Identifier: NCT02438306), which are being presented at the virtual European Society of Cardiology Heart Failure Annual Meeting 2021.



The data demonstrate the high CD34+ cell dosing is being achieved in the ongoing CardiAMP cell therapy heart failure trial. CardiAMP cell therapy is an investigational therapy being studied at 24 centers in the United States where patients believed to have compelling biologic signatures in their own bone marrow cells are having these cells processed at their bedside and delivered to targeted regions of damage in their hearts.

"These early data are encouraging, showing that our CardiAMP cell therapy platform can achieve compelling therapeutic dosages which based on the totality of available data show promise for the ongoing pivotal heart failure trial to provide benefit to patients. To date, the reliable selection of patients, processing of cells, and efficient delivery of high doses of these cells to specific target locations in the heart have all been considered key obstacles in achieving a safe and effective therapy," said Ian McNiece, Ph.D., BioCardia's Chief Scientific Officer. "The compelling dosage data relative to other previous clinical trials released in abstract form today follows our third Data Safety Monitoring Board positive review and FDA allowing an earlier cross over option for the control group patients. Recommendations from the fourth DSMB review for the trial are imminent."

Data on the CardiAMP Cell Therapy platform were outlined in the abstract for the poster presentation and made available to the public online today. The full poster will be available to ESC HF conference participants beginning Tuesday, June 29.

High doses of CD34+ cells delivered to patients in the CardiAMP Heart Failure Trial

Authors: Amish N Raval M.D., et. al. on behalf of the CardiAMP Heart Failure Trial Investigators

Key takeaways include:

* CardiAMP cell therapy achieves a mean therapeutic dosage of 627,000,000 total nucleated cells (TNC), inclusive of mean number of 4,500,000 CD34+ cells in the ongoing pivotal trial for patients with ischemic heart failure.

* Despite symptomatic heart failure, patient selection and point of care cell processing produces a high TNC and CD34+ cell dose. When paired with improved intramyocardial cell retention, the retained CD34+ dose exceeds those used in prior trials of enriched CD34+ cell therapy, the results of which supported clinical efficacy.