Low Back Pain: Mesoblast Receives Best Basic Science Award

In an August 1, 2016 news release, Mesoblast Limited has announced that the 24-month results from the 100-patient, four-arm, randomized, 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 July 27-30, and received the 2016 Best Basic Science Abstract award at the meeting.

Lead investigator and trial presenter Michael J. DePalma, M.D., 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.”

According to the news release, the following were some of trial results:

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

• 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 (the composite of both pain and functional responder status) through 24 months.

• A significantly greater proportion of subjects who received 6 million MPCs achieved the pain responder criteria at both 12 and 24 months (50% pain reduction from baseline, as measured using a visual analog scale, with no intervention) than saline-treated controls (50.0% vs 12.5%, p=0.020); pain responder criteria were met by 36.0% of patients who received 18 million MPCs and by 23% who received hyaluronic acid.

The news release indicated, “Mesoblast’s ongoing Phase 3 trial is recruiting 360 patients across 30 sites in the United States and Australia, randomized 2:1 to receive either 6 million MPCs or saline control. The trial’s primary endpoint of Overall Treatment Success (using a composite of 50% improvement in lower back pain and 15 point improvement in function at both 12 and 24 months) is an acceptable endpoint for product approval, as per guidance from the United States Food and Drug Administration (FDA). Subject to further discussions with the FDA, Mesoblast anticipates being able to provide interim data from the trial in early 2017.”

Dr. DePalma told OTW, “Patients tolerated the MPC injections and an appreciable proportion of them experienced clinically meaningful improvement in low back pain after undergoing injection of the MPCs into a symptomatic lumbar disc. No other intradiscal biologic treatment has shown results like this while undergoing a randomized controlled investigation.”

“If MPCs demonstrate similar results in the Phase 3 study, many of the patients with chronic low back pain and a single dark disc on MRI may benefit from an injection with MPCs.”