Column 1 0 Summary: 1
- Mesoblast reported results from a small N-17 study showing that a single intra-articular injection of cells reduced cartilage loss and bone changes as well as improved pain and function for over two years versus controls. We view that as more antidotal evidence that these cells have activity; the key issue now is proving it in pivotal studies.
- Focus on the following:
- Cogestive Heart Failure (CHF): The P3 study of MPC-150-IM continues to enroll (now well over 300 patients). The pre-specified interim analysis for futility in the first 270 patients was successfully completed in April. The P2b study in class IV patients should have data by YE2017.
- Rheumatoid Arthritis (RA): In the P2 trial of MPC-300-IV in biologic refractory Rheumatoid Arthritis, a single injection of cells has demonstrated sustained responses to 39 weeks and still going. The 12-month data is expected soon.
- Disc Degeneration: The P2 study of MPC-06-ID (single injection) demonstrated meaningful improvements in pain and function out to 3 years. The 360 patient P3 study is on tract to complete enrollment this year.
- Graft versus Host Disease (GVHD): MSC-100-IV was granted fast track designation in children with acute GVHD. The P3 trial (N=60) should complete enrollment and report top-line data later this year.
- Conclusion: The data continues to accumulate and suggest that regenerative cell therapy works in a wide range of indications. Mesoblast is making progress across multiple late stage studies with key data points ahead in 2017 that should continue to provide catalysts for the stock.
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