CLBS10

Phase 2 Product Candidate for ST-Elevation Myocardial Infarction (STEMI)

CLBS10 (formerly NBS10) is an investigational therapy designed to treat the damaged heart muscle following an acute myocardial infarction (“AMI” or heart attack).  CLBS10 is thought to work by increasing microvascular blood flow in the heart muscle via new blood vessel development and formation. These new vessels can reverse the restriction of blood supply caused by a heart attack and rescue the damaged tissue from eventual cell death. 

After a thorough review, the Company has set the future direction for its ischemic repair program. Based on an analysis of the available Phase 2 data from the PreSERVE-AMI trial, an updated commercial assessment considering all major potential relevant cardiovascular indications and consultation with the Company’s new cardiovascular scientific advisory board and the Science and Technology Committee of the Board of Directors, Caladrius has decided that it will not pursue further development of the acute myocardial infarction indication upon completion of the ongoing PreSERVE-AMI Phase 2 clinical study. However, the positive suggestion of safety and therapeutic activity seen to date in the PreSERVE-AMI trial supports the underlying platform technology and enables the Company’s exploration of more commercially viable indications of chronic heart failure and/or critical limb ischemia as targets for further development. The Company will continue to seek partnerships for all the indications in this platform, which will be necessary for Caladrius to proceed to the next steps in clinical development.


PreSERVE 6- and 12-month Interim Conclusions*

  • CD34 cell dose-dependent trend in reduced major adverse cardiac events (MACE)
  • Reduced serious adverse events (SAEs) frequency trend in higher CD34 cell dose groups (12 month data)
  • No deaths in the CLBS10 treated group (12 month data)
  • CD34 cell dose-dependent trend in improved left ventricular ejection fraction (LVEF) and in reduced infarct size
  • No correlation between experimental endpoint of perfusion and treatment

* Based on data collected at 6 months except where noted

Taken together, these preliminary results suggest that CLBS10 positively impacts the preservation of myocardial function and the prevention of adverse events post-STEMI. The favorable clinical outcomes encourage continued development for the platform. For more details, please visit the trial's listing on clinicaltrials.gov.

PreSERVE Phase 2 Study targeting acute myocardial infarction

Description

Randomized (1:1), double-blind, placebo controlled trial for post-AMI (STEMI) patients

Primary Endpoints and Key Secondary Endpoint

Change in cardiac perfusion from baseline to 6 months (exploratory)

Incidence rates of SAEs and MACE (regulatory – AMI)

LVEF change from baseline to 6 months (regulatory – heart failure)

Key Inclusion Criteria

Confirmation of ST Elevation MI

Ejection fraction < 48% at day 4 by CMR

State-of-the-art care post stenting

Study size

161 patients, 60 centers in United States

Treatment

Single dose via infarct related artery with minimum dose for release ≥ 10 million ± 20% CD34+ cells

Dose determined by volume of cells aspirated and manufacturing

Control

Matching infusion with placebo