Mesoblast presents 24-month trial results

Company News

Mesoblast (ASX:MSB) has announced that the 24-month results from the 100-patient, four-arm, randomised, placebo-controlled Phase 2 trial of its chronic low back pain (CLBP) product candidate MPC-06-ID were presented at the 24th Annual Scientific Meeting of the Spine Intervention Society (SIS) held in New Orleans last week, and received the 2016 Best Basic Science Abstract award at the meeting.

The trial results were selected following peer review for a podium presentation entitled “A Randomized, Controlled Trial Evaluating the Safety and Effectiveness of Immunoselected, Allogeneic, Mesenchymal Precursor Cells for Treatment of Chronic Low Back Pain".

Lead investigator and trial presenter Dr Michael DePalma, President and Medical Director of Virginia iSpine Physicians, stated: "The long term results from this study indicate that a single injection of Mesoblast’s allogeneic Mesenchymal Precursor Cells (MPCs) into the disc of patients with moderate to severe CLBP due to degenerative disc disease was well tolerated and provided substantial improvement in pain and function over 24 months compared with control therapies."

The procedure and treatment were well tolerated, without any significant differences in safety between cell-treated patients and controls.

Other trial results include, the 6 million MPC dose, currently used in the ongoing Phase 3 trial, resulted in the greatest proportion of patients meeting the Phase 3 primary endpoint of Overall Treatment Success through 24 months, and a significantly greater proportion of subjects who received 6 million MPCs achieved the pain responder criteria at both 12 and 24 months than saline-treated controls.

According to Dr DePalma, “If findings from the ongoing Phase 3 trial are comparable, Mesoblast’s MPCs could become a valuable treatment for a significant number of people suffering with chronic low back pain who currently have no other viable option.”

The company's ongoing Phase 3 trial is recruiting 360 patients across 30 sites in the US and Australia. Subject to further discussions with the FDA, Mesoblast anticipates being able to provide interim data from the trial in early 2017.