Mesoblast Ltd ADR (MESO)

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MPC-150-IM is our Phase 3 product candidate under investigation for the treatment of moderate to advanced chronic congestive heart failure (CHF) currently enrolling approximately 600 patients across North America.

We completed a Phase 2 trial in patients with Class II/III (New York Heart Association) CHF in 2013. Click here for clinical trial results.

The United States National Institute of Health has completed enrollment of a 159-patient Phase 2b trial using MPC-150-IM in patients with end-stage CHF requiring mechanical circulatory support.

Patients with advanced and end-stage heart failure represent a serious unmet medical need.

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MPC-06-ID is our Phase 3 product candidate under investigation for the treatment of chronic low back pain (CLBP) due to disc degeneration.

The primary objective of our Phase 2 study was to evaluate the safety of MPCs in CLBP. Secondary objectives were to evaluate efficacy parameters such as radiographic, low back pain, function/disability, medication usage, work status and quality of life improvement measures. Click here for the clinical trial results.

A Phase 3 clinical trial has completed enrollment of 404 patients.

Most current treatments for CLBP focus on pain relief rather than addressing the underlying degenerative nature of the disease. We believe MPC-06-ID has the potential to fill an unmet treatment gap for this large population of patients.

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MSC-100-IV is our Phase 3 intravenously-delivered product candidate, which is being developed for the treatment of acute Graft Versus Host Disease (aGVHD) following allogeneic bone marrow transplantation.

An open label Phase 3 trial for MSC-100-IV has completed enrollment of 55 children with steroid-refractory aGVHD in the United States.

This Phase 3 trial successfully met its primary endpoint of Day 28 Overall Response (OR) to remestemcel-L treatment, with 69% of patients achieving this endpoint compared to the protocol-defined historical control rate of 45% (p=0.0003). In patients who had a positive OR to treatment with remestemcel-L at Day 28, survival was 87% at Day 100. At Day 180, survival in these patients was 79% (p=0.001 by Kaplan-Meier survival estimates compared to non-responders). Overall Day 180 survival for the entire remestemcel-L treated group was 69%. Historical survival rates in patients with Grade C/D disease and failure to respond to steroids have been only 10-30%.

Mesoblast’s goal is for remestemcel-L to be the first commercially manufactured allogeneic cellular medicine available in the United States.

Mesoblast’s licensee in Japan for aGVHD, JCR Pharmaceuticals Co. Ltd., is marketing its its MSC-based product for children and adults with aGVHD. TEMCELL® HS Inj. was the first allogeneic cell-based product to receive full approval in Japan.

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MPC-300-IV is an intravenously-delivered immunomodulatory product candidate for the treatment of chronic inflammatory conditions.

Randomized, placebo-controlled Phase 2 trials of MPC-300-IV have been completed in patients with biologic-refractory rheumatoid arthritis and diabetic nephropathy. Both trials reported promising results in these diseases with high, unmet medical needs.

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A Phase 2 trial in patients with diabetic nephropathy was completed in 2015. The results were presented at the late-breaking scientific sessions of the 75th annual meeting of the American Diabetes Association in June 2015. Click here for results from this Phase 2 trial.

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https://www.mesoblast.com/product-candidates/lead-product-candidates