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Unassigned

New Medicines

Ischaemic heart failure - after myocardial infarction

Information

New molecular entity
BioCardia
BioCardia

Development and Regulatory status

None
None
Phase II Clinical Trials
Nov 20BioCardia reportsd that, the US FDA raised additional questions related to long-term preclinical follow-up results from the studies targeted to treat patients with heart failure who are ineligible for the company ’s autologous cell therapy due to their cell potency assay score (CardiAMP HF trial). Company addressed all questions on the clinical protocol and the chemistry manufacturing and controls to the FDA satisfaction. The preclinical studies requested by the FDA were completed and the data reports provided to the agency [5].
Aug 20BioCardia reports that it has sumbitted its response to the US FDA comments on its IND application for CardiALLO cell therapy [5].
Apr 20BioCardia does not anticipate generating revenues from sales of the CardiAMP cell therapy system, the CardiALLO cell therapy system or any other biotherapeutic candidates within the next few years [4].
Dec 19BioCardia files an IND submission for CardiALLO cell therapy trial targeting patients excluded from CardiAMP HF trial that uses their autologous bone marrow cell therapy [5].

Category

An allogeneic culture expanded mesenchymal stem cells derived from bone marrow from an universal donor
Heart failure (HF) is a common complication of MI, with the estimated incidence varying from 10% to 40%.4 Post-MI HF is associated with a markedly elevated risk of death, with an estimated median survival of ≈4 years [1].
Ischaemic heart failure - after myocardial infarction
Intracoronary

Trial or other data

Apr 20BioCardia has co-sponsored three clinical trials for MSCs for the treatment of ischaemic systolic heart failure. In substantially similar trial designs, the POSEIDON PI/II trial compared autologous MSCs to allogeneic MSCs, the TACHFT-MSC PII trial compared autologous MSCs to placebo,and the TRIDENT PII compared allogenic MSCs at different doses. The first two trials shared common arms of autologous MSCs, enabling a bridge to placebo, leading BioCardia to conclude that allogeneic MSC therapy has potential to be superior to placebo. The IND for the TACHFT trial was filed with the FDA Center for Biologics Evaluation and Research in 2008 by the University of Miami, our co-sponsor for the trial. The POSEIDON trial and the TRIDENT trials were submitted by amendment under the same IND filed for the TACHFT study,and was co-sponsored by the University of Miami, the National Institutes of Health and us. The results from all three of these studies can be submitted to the FDA in support of an IND for the CardiALLOCell Therapy System [4].
Sep 17University of Miami completes a PII trial that evaluated the safety and efficacy of two doses of allogeneic human mesenchymal stem cells (20 million cells and 100 million cells) using BioCardias Helical infusion system, in patients with chronic ischaemic left ventricular dysfunction secondary to myocardial infarction (TRIDENT; NCT02013674). The randomised, double blind trial was initiated in February 2014, and enrolled 30 patients in the US [3].