Strong early results from Mesoblast spinal trial

By Dylan Bushell-Embling
Tuesday, 23 April, 2013

Strong early results from Mesoblast spinal trial

Mesoblast (ASX:MSB) has completed a six-month follow-up for a phase II trial of its mesenchymal precursor cells (MPCs) in intervertebral disc repair.

The company expects to be able to report the full results from the 100-patient trial of its adult stem cells in the third quarter. A positive outcome will allow Mesoblast to proceed to phase III studies.

Mesoblast also revealed it has concluded an interim analysis of the results, which commenced when 50% of patients had completed the six-month follow-up.

The results so far suggest that a single dose of the adult stem cells significantly reduced back pain and improved function when compared to the control group.

The 100 patients enrolled in the trial were split into four groups. Two were control groups, receiving either saline or hyaluronic acid injections alone. The remaining two groups received either six million or 18 million MPCs in a hyaluronic acid carrier.

Participants will continue to be monitored up until a 36-month follow-up.

The interim analysis shows that patients receiving six million MPCs reported a 69% mean reduction in back pain and 51% mean improvement in function, compared to 38% and 19% respectively for patients receiving hyaluronic acid alone.

But the MRI status of spinal disc morphology remained unchanged relative to the baseline in all four groups.

Interestingly, the six million MPC group has shown significantly higher treatment success rates than the higher dose, due to a lower efficacy and increased incidences of adverse events among the 18 million MPC group.

“We are pleased that the interim results of this important study have identified a low MPC dose that appears to be safe and effective for inducing sustained improvement in low back pain and function,” Mesoblast CEO Professor Silviu Itescu said.

Mesoblast is also currently in clinical trials for its MPCs as treatments for conditions including rheumatoid arthritis and congestive heart failure.

The company last month raised $170 million through a placement to support its clinical development programs.

Mesoblast shares were trading 1.12% higher at $5.43 as of around 3.30 pm on Monday.

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