OREANDA-NEWS. June 29, 2015. Cell Therapy Ltd ("CTL"), a development stage pharmaceutical company with a portfolio of allogeneic regenerative medicines in clinical trials, reported average 24-month (19-29 months) MACE-free survival for all patients in the Heartcel™ trial studying myocardial regeneration. This means that in these patients, suffering from advanced heart failure, all are still alive after an average of two years vs. up to an expected 70% annual mortality rate, and none have suffered cardiac events such as heart attack or stroke.

Today, at the International Society of Stem Cell Research (ISSCR) Annual Conference in Stockholm, CTL reported follow-on data from the Heartcel™ Phase II clinical trial:

·     MACE-free survival in all patients at an average of 24-months (19-29 months)

·     70% Quality of life improvement measured by MLHF

The Heartcel™ Phase II clinical trial studied patients at high risk of incomplete re-vascularization (ICR) undergoing Coronary Artery Bypass Graft (CABG), and investigated a new regenerative cell type, the iMP cell (immuno-modulatory cell), as an adjuvant to mitigate the mortality and morbidity associated with ICR. HeartcelTM has been designed as a cardiac specific cell therapy, and is the first to demonstrate heart regeneration in humans.

At the original 12-month follow up the trial met all study endpoints reporting statistical and clinically significant results: Major Adverse Cardiac Event (MACE)-free survival in all patients, improved Left Ventricular Ejection Fraction (LVEF) of 30%, reduced Left Ventricle (LV) scar size of 40% and improved Quality of Life of 50%.

Today CTL reported average 24-month (19-29 month) follow up results for MACE-free survival and quality of life improvement, unprecedented data for a trial of this kind for patients with advanced heart failure.  (See Abstract 2 in notes below).

The iMP cell is a novel regenerative cell discovered by Nobel Prize winner Sir Martin Evans, CTL's Chief Scientific Officer. The iMP cell was presented at the British Society of Cell and Gene Therapy Annual Conference, on 11 June 2015 and forms a novel and distinct family of mesodermal progenitor cell. iMP cells express cardiac-specific and immuno-modulatory phenotype and form the basis of allogeneic or "off the shelf" cellular regenerative medicines.  (See Abstract 1 in notes below).

CTL's proprietary platform technology has generated a portfolio of allogeneic tissue-specific regenerative cellular medicines that are in late stage clinical trials including Heartcel™, and cellular therapies for orthopaedic and dermatological conditions.

Professor Stephen Westaby, John Radcliffe Hospital, Oxford, the principal investigator for the Heartcel™ trial, said: "In the Heartcel™ clinical trial, all patients survived and were free of major adverse events at 19-29 months. SPECT imaging demonstrated the change in hypo-kinetic tissue to functional myocardial at the site of injection. There was an average 30% improvement in heart function, 40% scar size reduction and 50% quality of life improvement. While the study cohort was small, the results were highly clinically relevant and statistically significant."

Ajan Reginald, Chief Executive Officer of Cell Therapy Ltd., commented: "Rapid translation of in-house research into meaningful clinic benefit for patients in the Heartcel™ trial exemplifies our mission to develop game-changing regenerative medicines. We delighted all the Heartcel™ patients remain alive and free of major adverse cardiac events for an average of 24 months. Tendoncel™ and Myocardion™ also entering late-stage trials, expands CTL's regenerative medicine pipeline into Tendon repair and moderate heart failure. Regenerative medicine is a disruptive technology and CTL's seems well placed to be at the forefront of this new class of medicines."