Updated on 7 February 2013
What are the products in Mesoblast's pipeline and at what stages of clinical trials are they?
Among the intravenous administration products, Mesoblast is developing a high margin product franchise targeting a wide range of systemic diseases utilizing an intravenous formulation of allogeneic MPCs. These disorders include type 2 diabetes and its renal complications, inflammatory diseases of the joints such as rheumatoid arthritis, and inflammatory lung diseases such as asthma.
A phase II randomized, placebo-controlled dose escalation clinical trial is currently evaluating Mesoblast's MPC technology in 60 patients with type 2 diabetes at multiple trial sites in the US. In addition to monitoring safety and tolerability, the trial is evaluating glucose lowering effects of MPC treatment. This study will also explore effects on inflammatory markers including C-reactive protein (C-RP).
In January 2013, the FDA cleared a phase II trial to evaluate the effects of MPCs in patients with rheumatoid arthritis who have failed other biological therapies.
Additionally, Mesoblast is conducting preclinical studies to evaluate MPC effects in pulmonary conditions, such as asthma and idiopathic pulmonary fibrosis. In local administration products, Mesoblast is targeting degenerative diseases of the spine that represent a large and growing orthopedic market segment. These include development of a spinal fusion product, NeoFuse, for patients with advanced disc degeneration who need fusion surgery.
Encouraging phase II results suggested that NeoFuse is as effective for interbody lumbar fusion as the gold standard, bone autograft, and eliminates the need for autograft harvest and its attendant morbidity risks. Mesoblast is planning to begin a phase III trial for lumbar spinal fusion in late 2013. esoblast is also investigating a product in the much larger market of intervertebral disc damage. The results of a 100-patient phase II trial assessing MPCs for the treatment of disc repair are expected in mid-2013.