In a subsequent meeting in 2018, the FDA advised Mesoblast
that the defined endpoint of reduction in major GI bleeding and rehospitalization is an appropriate clinically meaningful endpoint and could be the basis of an approved indication for use of Revascor given the life-threatening nature of the condition, and the RMAT designation under which Revascor is being regulated.
is in discussions with the FDA regarding a potential approval pathway under the product's existing Regenerative Medicine Advanced Therapy (RMAT) designation for this life-threatening condition.
expects to submit the first module "shortly."
ACR70, or 70 percent improvement, was seen in 36 percent after one infusion of the Mesoblast
treatment, as compared to no such improvement reported in the patients in the placebo group.
* The report reviews current pipeline of Mesoblast
Limited's human therapeutic division and enlists all their major and minor projects
Limited is a developer of biologic products for the broad field of regenerative medicine.
selected Rave for its superior user experience and comprehensive functionality.
The MPC dose ranges which will be tested in the Phase 2 clinical trial are based on results from Mesoblast
's preclinical studies in 17 non-human primates with obesity-related Type 2 diabetes.
The trials are being conducted in conjunction with Mesoblast
U.S.-based sister company, Angioblast Systems Inc.
Earlier this year, Mesoblast
initiated filing of a rolling submission for a Biologics License Application (BLA) to the FDA for the use of remestemcel-L in children with steroid-refractory acute GVHD.
"Confirmation of our previous observations that Mesoblast
's cell therapy reduced major bleeding episodes and related hospitalizations would identify a therapeutic approach that could greatly benefit these patients," said cardiac surgeon of the University of Michigan, co- principal investigator of the recently completed 159-patient study coordinated by InCHOIR.
In the previous year, Mesoblast
's (ASX:MSB)(USOTC:MBLTY) wholly-owned subsidiary signed an agreement for the acquisition of Osiris' culture-expanded mesenchymal stem cell (ceMSC) business, including Prochymal, valued at up to USD100m in initial consideration, as well as milestone payments and future royalties.