I can only read the abstract of the study, but several things I...

I can only read the abstract of the study, but several things I take from it are:

1. This Japanese study is a verification of Temcell results and was completed in a real world setting (i.e. not under trial conditions) and totally independent of Mesoblast. This can only work in Mesoblast's favour for gathering evidence of effectiveness and efficacy.

2. The study states that Temcell improved survival across the entire cohort of patients, where after 6 months the treatment achieved 40% survival rate. Compared to previous trial results announced by Mesoblast, this is very low.

3. On face value I was shocked at 40% survival rate after 6 months, but, the study doesn't distinguish between patients of varying age. Mesoblast have clearly stated in at least one previous announcement that the treatment wasn't anywhere near as effective on adults as it was for children.

Unless the results from children being administered Temcell are segregated from the entire cohort, I don't believe these findings as they are would be beneficial to Mesoblast and their attempts to get FDA approval for Temcell for GVHD in children.

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http://investorsmedia.mesoblast.com/static-files/c0807204-3d05-4b03-adb9-d05066d8491d

The trials highlighted in the three articles all evaluated the same treatment regimen of RYONCIL, withpatients receiving twice weekly intravenous infusions of 2 million cells per kg body weight over a four week period. RYONCIL was well-tolerated in all studies with no identified safety concerns. The threetrials were:

Study 275: An Expanded Access Program in 241 children across 50 centers in eight countrieswhere RYONCIL was used as salvage therapy for steroid-refractory acute GVHD in patientswho failed to respond to steroid therapy as well as multiple other agents.o Day 28 Overall Response (OR), the primary endpoint, was achieved in 65% of subjects.Survival through 100 days was significantly greater in patients who achieved a day 28 OR(82%) compared with patients that did not achieve day 28 OR (39%), with 67% overallday 100 survival.

Study GVHD001/002: A Phase 3 single-arm trial in 55 children across 20 centers in the UnitedStates where RYONCIL was used as the first line of treatment for children who failed to respond tosteroids for acute GVHD.o Consistent with the findings in Study 275, Day 28 OR was achieved in 70% of children. Thiswas statistically significant compared to the pre-specified control value of 45% (70.4% versus45%, P =0.0003). As in study 275, clinical response at day 28 was highly predictive ofimproved survival through day 100 (87% compared to 47% in patients that did not achieveday 28 OR P = 0.0001). Similar predictive value of day 28 was also seen in survival throughday 180 (79% vs. 43.8%, P= 0.003). Overall survival was 74.1% at day 100 and 68.5% atday 180.o These results were significantly higher than those from matched control pediatric subjectsfrom the contemporaneous database of the Mount Sinai Acute GVHD International Consortium(MAGIC), accessed to provide an unbiased and independent estimate of response rates andoutcomes in matched pediatric control patients treated with institutional standard of care. Inthe MAGIC controls, Day 28 OR was 43% and Day 100 survival was 57%.

3. Study 280: A Phase 3 randomized placebo-controlled trial in 260 patients, including 28 children,across 72 centers in seven countries where RYONCIL or placebo were added to second line therapy inpatients with steroid-refractory acute GVHD who failed to respond to steroid treatment.

o Among high-risk children and adults who had the most severe disease stages, day 28 OR wassignificantly greater in the RYONCIL treated group (58% versus 37%; P = 0.03) compared toplacebo. Among the standard risk patients there was no significant benefit of RYONCILtreatment. Within the pediatric patients in this study (n=28) day 28 OR was significantlygreater in the RYONCIL group compared with the placebo group (64% vs 36%, respectively,P=0.05).

o These Phase 3 results provide prospective, randomized controlled data which are supportivefor the use of RYONCIL in children and high-risk adults with steroid-refractory acute GVHD.

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