Key points from article :
The first patient was successfully dosed in cardiomyopathy study.
Announces an update with lead therapeutic candidate CLXR-001 successfully dosed in the Company’s Heartcel clinical trial of its novel iMP cells in patients with cardiomyopathy.
CLXR-001 allows rapid point-of-care use of Celixir’s novel allogeneic (off-the-shelf) iMP cells without the requirement for a cell culture laboratory.
In consultation with the Medicines and Healthcare products Regulatory Agency (MHRA), Celixir has suspended the current Heartcel clinical trial and replace it with a revised protocol.
Professor Stephen Westaby said: “A 2012 investigator-led trial showed no adverse effects and patients are still doing well several years later.”
A significant reduction of scar tissue in the damaged heart muscle conveyed a reduced likelihood of developing heart failure.
Professor Sir Martin Evans added: “We are pioneering a cellular therapy aimed at progressing the heart regeneration field.”
This trial highlights a novel cell therapy with an off-the-shelf product formulation, GMP manufacturing and a UK-approved clinical trial.