Mesoblast partner cleared for phase III heart trial

Mesoblast (ASX:MSB) shares climbed 9% after the US FDA last week signed off on a phase III trial of the company’s mesenchymal precursor cells (MPCs) in chronic congestive heart failure.

Mesoblast’s development partner Teva Pharmaceutical Industries has received regulatory approval to commence the trial as part of an Investigational New Drug filing.

Teva now expects to commence recruitment for the multicentre trial shortly. The company aims to enrol around 1700 patients for a double-blinded, randomised, placebo-controlled study.

Patients will receive a single dose of 150 million MPCs via a transendocardial injection catheter. The primary efficacy endpoint of the trial will be incidences of heart failure-related major adverse cardiac events (HF-MACE), as measured by a blinded committee.

Patients given the 150 million MPC dose during a previous phase II trial have not experienced any HF-MACE over a three-year follow-up period. This compares to an incidence rate of around 30% for the control group.

“We believe that Mesoblast’s proprietary mesenchymal lineage cells have the potential to offer long-term beneficial outcomes to the millions of patients suffering from heart failure worldwide,” Mesoblast CEO Silviu Itescu said.

Mesoblast secured FDA approval to manufacture MPCs for the upcoming phase III trial in November last year.

Earlier that year, Mesoblast was forced to deny speculation that Teva was considering pulling out of their partnership and rumours that the phase III trial will not be moving forward.

Mesoblast (ASX:MSB) shares grew 9.63% to $6.60 after it announced the FDA’s decision on Thursday. The shares have since kept most of their gains and were trading at $6.51 as of around 2 pm on Monday.