Experimental stem cell treatment shows promise in rheumatoid arthritis
pharmafile | August 10, 2016 | News story | Research and Development | Mesoblast, rheumatoid arthritis, stem cell treatment
Mesoblast has announced results from a Phase II clinical trial evaluating MPC-300-IV in patients with biologic refractory rheumatoid arthritis (RA) which showed the drug to be well tolerated, as well as demonstrating dose-related improvements in clinical symptoms, physical function and disease activity through the 12 week primary endpoint.
The Australian firm now hopes to secure an industry partner for Phase III trials for the stem cell treatment. MPC-300-IV comprises 2 million immunoselected and culture-expanded mesenchymal precursor cells/kilogram which are intravenously delivered. While existing biologic RA treatments target individual cytokine pathways, such as TNF-alpha and interleukin-6, they do not do so concomitantly. There are at least two ways that this stem cell candidate targets RA, including immunomodulatory mechanisms of action and synoviocyte inhibitory mechanisms of action.
In the Phase II trial, 48 patients with RA were recruited who were on a stable regimen of methotrexate and had an inadequate prior clinical response to at least one anti-tumour necrosis factor agent, such as Humira (adalimumab), Enbrel (etanercept) and Remicade (infliximab).
The measures for judging clinical improvement included changes in the American College of Rheumatology (ACR) composite clinical response score, and the health assessment questionnaire-disability index. MPC-300-IV demonstrated improvements versus placebo on each measure.
Dr Allan Gibofsky, professor of medicine and public health at Weill Cornell Medical College, says: “The safety and efficacy results of this study are very encouraging and suggest that Mesoblast’s cell therapy has the potential to fill the major unmet medical need of the biologic refractory RA population, where agents that provide consistent durable effects without the risk of opportunistic infections or malignancies are sorely needed.”
Sean Murray
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