The Trial of δ--Aminolevulinic Acid to Enhance Myocardial Protection (TALEN) will take place across the John Radcliffe Hospital, Oxford and the Queen Elizabeth Hospital, Birmingham.
During coronary artery bypass surgery or aortic valve replacement, there is a period of time where the heart is without a blood supply, leading to long term damage in some instances. While surgical protocols are in place to limit this damage, TALEN seeks to improve on these established techniques by steeling the heart against injury, prior to surgery. This is the first UK-based clinical trial of its kind using proprietary compound δ--Aminolevulinic Acid (ALA) that SBI Pharmaceuticals has financed.
The clinical trial builds on existing work conducted at the University of Oxford by Prof Houman Ashrafian, which explored the concept of metabolic ‘cardioprotection’. In this work, Prof Ashrafian found that the compound ALA, combined with iron, could protect against the damaging metabolic consequences of depriving the heart, albeit temporarily, of a blood supply during surgical interventions.
Speaking about the new trial, Prof Ashrafian said:
“Heart disease is one of our biggest medical challenges and in UK we currently perform approximately 36,000 cardiac surgical procedures a year. These operations, now performed at relatively low risk, confer substantial and durable benefits for the patients they treat. Unfortunately, collateral damage caused by surgery can lead to serious complications, impacting on recovery and quality of life. We believe the addition of a pre-surgical treatment approach would not only improve the outcome of the surgery itself, but limit long term damage. In order to drive innovative approaches, collaboration is key and we’re looking forward to working with SBI Pharmaceuticals to investigate whether years of laboratory experiments can now make a difference to patients.”
The team will work closely with colleagues at the Queen Elizabeth Hospital in Birmingham, led by Mr Neil Howell, to recruit 400 people about to undergo coronary bypass surgery or aortic valve replacement. As part of the randomised controlled clinical trial, volunteers will take either ALA (combined with iron) or a placebo, for three days leading up to surgery. The trial team will also use the trial to tease apart the mechanism of action for ALA in this context.
Mr. Kitao from SBI said:
“While we’ve seen the benefits of 5-ALA in other disease areas such as cancer, this is our first trial of the amino acid in cardiology. SBI has supported academic research at the University of Oxford throughout the pre-clinical stage of this study and we are pleased to continue that partnership as we move into the clinic. This international collaboration will help expand our portfolio of healthcare solutions.”