- Mesoblast’s (MSB) phase 3 trial for Revascor in chronic heart failure has excelled the number of primary endpoint events required for trial completion
- The trial has now begun final study visits for all surviving patients with a target or last patient visit at the end of January 2020
- Once the last patient has completed their last visit, final data collection and entry processes will be performed
- Revascor is injected into the heart muscle and releases cells which interact with damaged tissue and repairs them
- Mesoblast has ended the day up a slight 0.79 per cent with shares trading for $1.92 apiece
Mesoblast’s (MSB) phase 3 trial for Revascor in chronic heart failure has excelled the number of primary endpoint events required for trial completion.
The cardiovascular outcomes trial has now begun final study visits for all surviving patients with a target of last patient and last visit at the end of January 2020.
Once the last patient has completed their last visit, final data collection and entry processes will be performed and the database locked up.
All surviving patients will have been followed for at least 12 months, with an average follow up period of 30 months.
The results from this trial are expected to be read-out by mid-2020.
The double-blind, randomised, sham procedure-controlled phase 3 trial is evaluating Revascor as an add-on treatment for non-fatal heart failure-related major adverse cardiac events (HF-MACE) and terminal cardiac events in 566 patients with advanced chronic heart failure.
The trial was designed to collect more than 531 total primary endpoint events based on expected rates of HF-MACE in similarly advanced populations of heart failure patients and on treatment benefits seen with Revascor in earlier phase 2 trial results.
In April 2017, Mesoblast reported that a pre-specified interim analysis of the primary efficacy endpoint in the phase 3 trial’s first 270 patients was successful.
“We are very pleased to have achieved this important milestone in the largest trial of cell-based therapy for patients with advanced heart failure,” Mesoblast Chief Executive Dr Silviu Itescu commented.
“These patients have exhausted other treatment alternatives, and have the highest burden of disease, recurrent hospitalisations and mortality,” he added.
Chronic heart failure is characterised by an enlarged heart and insufficient blood flow to the organs and extremities of the body.
It is a progressive disease and can be caused by many factors that put an excess demand on the heart muscle such as high blood pressure, infections, faulty valves or congenital heart problems.
In the United States alone, there are more than 6.5 million patients with heart failure and approximately 15 per cent of this population has advanced chronic heart failure and is at high-risk for recurrent HF-MACE.
Prevalence of chronic heart failures is expected to grow 46 per cent by 2030, affecting more than eight million Americans.
Current treatment for heart failure includes eating less salt, limiting fluid intake, physical exercise, weight loss and quitting smoking.
Medication and surgery can also help but usually if other avenues have been taken.
Mesoblast’s Revascor product is a tier 1 candidate which consists of 150 million mesenchymal precursor cells (multi-potent stem cells found in bone marrow) and is administered by a direct injection into the heart muscle.
These precursor cells release a range of factors when triggered by specific receptor-ligand interactions within the damaged tissue.
Based on preclinical data, it is believed that these factors induce functional cardiac recovery by simultaneous activation of multiple pathways including the reduction in harmful inflammation, reduction in cardiac scarring, and regeneration of heart muscle.
Mesoblast has ended the day up a slight 0.79 per cent with shares trading for $1.92 apiece in a $1.022 billion market cap.