dm+d

Unassigned

New Medicines

Ischaemic heart failure - after myocardial infarction

Information

New molecular entity
BioCardia
BioCardia

Development and Regulatory status

None
None
Phase III Clinical Trials
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].

Category

An autologous bone marrow derived cell therapy (using a patients own cells), injected into damaged heart tissue through a catheter
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
Intracardiac

Trial or other data

Jan 21In the latest company annual report, BIoCardia notes that the independent Data Safety Monitoring Board (DSMB) completed a prespecified data review of the trial in September 2019, which included follow-up results on 50 patients randomized in the trial as of August 31, 2019. The DSMB indicated there were no safety concerns with the study results and recommended that the trial continue as planned. On March 31, 2020, the Company announced that the DSMB completed its second prespecified data review,and that based on the DSMB’s review of all available safety data for patients randomized into the trial to date, there were no safety concerns and that the DSMB recommended continuing the trial as planned. Another interim DSMB readout is planned in Q4 2020, which will include a non-futility analysis with 60 patients having reached one-year follow-up. This fourth quarter of 2020 event is anticipated to be the first randomized efficacy data set including the primary endpoint reviewed by the DSMB [4].
Oct 20PIII CardiAMP heart failure trial is recruiting [3].
Dec 16PIII CardiAMP heart failure trials starts (NCT02438306). 250 adults will be recruited in the US only. This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control), sham-controlled, patient- and evaluator-blinded study. Primary outcome is a composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12. Collection of these data is due to complete Dec 21 [3].

Angina pectoris, chronic refractory myocardial ischaemia

Information

Licence extension / variation
BioCardia
BioCardia

Development and Regulatory status

None
None
Phase III Clinical Trials
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 [3].

Category

An autologous bone marrow derived cell therapy (using a patients own cells), injected into damaged heart tissue through a catheter
8% of men and 3% of women aged 55-64 years have, or have had, angina. Coronary revascularisation is required in those at high risk and those who have failure to be controlled by medical therapy. Estimates for annual mortality rates range from 1.2-2.4% per annum, with an annual incidence of cardiac death between 0.6 and 1.4% and of non-fatal myocardial infarction between 0.6% and 2.7% [1].
Angina pectoris, chronic refractory myocardial ischaemia
Intracardiac

Trial or other data

Sep 20A pivotal PIII CardiAMP CMI trial is due to starts (NCT03455725). Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase. In the subsequent randomised phase, up to 333 subjects with refractory chronic myocardial ischaemia CCS class III-IV will be randomised. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system and up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells). Patients will be enrolled in the US only and collection of primary outcome data (Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol) is due to complete Dec 2022. However, timing is entirely dependent on the course of COVID-19 and the response in the United States [2,3].