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Mesoblast Limited (ASX:MSB) presented the results of the phase 2 trial from the test conducted on 159 patients, on November 12, 2018. The end results from the test conducted by the implantation of the left ventricular assist device on the heart failure patients in the end stage indicated significant reduction by the Mesoblastâs allogeneic cell therapy MPC-150-IM towards the reduction of major gastrointestinal bleeding episodes and related hospitalizations, severe complications that impact almost 40% of LVAD recipients. The positive outcome from the clinical trial further confirms the results noted in an earlier 30-patient pilot trial 2 that provided the base for the Regenerative Medicine Advanced therapy designation.
Under its RMAT designation, Mesoblast has received special guidelines from the FDA. In accordance with these guidelines decrement in the major gastro intestinal bleeding episode and the concerned hospitalizations under the current trial will be considered as a clinically meaningful outcome which can meet the requirements of an approvable regulatory endpoint. Contrary to this designation, FDA has recommended that the primary end point under the current trial of temporary weaning from the full left verticular assist device will be considered as a biomarker and will not be considered as the clinically meaningful outcome.
Independent lead investigator and the Surgical Director of the Adult Heart Transplant Program, Dr Francis Pagani presented the results of the NHLBI-sponsored trial organized at the 2018 American Heart Association Scientific Sessions in Chicago on November 12, 2018. Dr Francis Pagani said that like the investigation done under the previous pilot trials, this trial too has cleared that the intramyocardial allogenic MPC injections were associated with a significant reduction in gastro intestinal bleeding which has been the major cause of morbidity and cost increase in LVAD patient management.
Some of the key outcomes from a six-month observation period under the treatment with the MPC-150-IM were:
- Achievement of the primary endpoint from full LVAD support was not fully accomplished.
- Mortality remained similar between the two groups as was mostly at 14% vs 15% at 12 months
- Null experience of a safety âstopping event for the trial by the patients was noted
- Cumulative incidence of major GI bleeding events showed significant reduction by 48% from 33% in controls to 17% (p=0.02)
- Gastro intestinal bleeding events showed significant reduction by 76% from 15.9/100 patient months to 3.8/100 patient months (p<0.001)
- Hospitalization rate has been one of the main causes of hospital readmissions that showed significant reduction by 65% from 0.21/100 patient months to 0.07/100 patient months (p=0.03).
- Despite of a non-significant increase in anti HLA class I antibodies in the MPC group, transplantation time was more or less similar between the two groups.
Chief Executive officer of Mesoblast, Dr Silviu Itescu further informed that the company is satisfied by the results presented by the independently conducted trial. The clinically positive outcome from the test conducted over these high-risk patients provides a strong support to the company in bringing their heart failure product MPC-150-IM to the markets and aiding the high-risk heart patients.
Trading was halted ahead of this announcement in the early session. With the announcement of the phase 2 trial results, the scrip traded under pressure and has slipped to the levels of $1.57, down about 28% on November 12, 2018.
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