Mesoblast Chief Executive Dr Silviu Itescu said: 'The FDA guidance on the pathway to registration for our heart failure product candidate in LVAD patients is a major step forward for our cardiovascular program.
The article said that cardiac inflammation drives heart failure progression, and said that, based on preclinical and Phase 2 clinical data, there is a biologic rationale for the use of
Mesoblast's MPCs in targeting this inflammatory process to improve heart failure outcomes.
Mesoblast will submit each module of the BLA to the FDA on a rolling basis as it is completed.
The
Mesoblast board and management thanked Hodgkinson for his significant contribution over the last four years.
A single intravenous infusion of
Mesoblast's allogeneic Mesenchymal Precursor Cell (MPC) product - MPC-300-IV - was well tolerated and showed improvement in clinical symptoms without serious side effects in the Phase 2 trial - a 12 week study of 48 patients, the company said in a (https://globenewswire.com/news-release/2016/08/08/862570/0/en/Phase-2-Trial-Results-of-Mesoblast-s-Cell-Therapy-Show-Dose-Related-Improvements-in-Biologic-Refractory-Rheumatoid-Arthritis.html) statement.
This report provides comprehensive information on the current therapeutic developmental pipeline of
Mesoblast Limited's, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type.
The benefits derived from acquiring the approved and late-phase MSC products include: *near term launch of a mesenchymal lineage product in major jurisdictions; *broadened late -phase clinical programs in strategic areas of focus; and *leveraged roll out of infrastructure, skills and expertise needed to commercialize Mesenchymal Precursor Cell (MPC) products
Mesoblast said.
Japanese patent number 5265190 provides
Mesoblast with exclusive commercial rights in Japan through to September 2025 to all compositions-of-matter and uses of its Mesenchymal Precursor Cell (MPC)technology platform, irrespective of the MPC tissue source, including bone marrow, adipose, placenta, umbilical cord and dental pulp.
Medidata s platform is seen as a cost-efficient solution to improve
Mesoblast s clinical trial efficiencies across multiple therapeutic areas, to effectively monitor and control risks, and to streamline trial execution to meet tight deadline goals.
- Phase 2 clinical trial of
Mesoblast's proprietary allogeneic, or off-the-shelf, Mesenchymal Precursor Cells (MPCs) in Type 2 diabetes patients cleared to commence by United States Food and Drug Administration (FDA)
(Frazer PA) took a $220 million, 20% stake in
Mesoblast Ltd.
SciTech21-20 September 2006-Australia-Based
Mesoblast Announces Positive Results in Trials Using Stem Cells to Treat Heart Disease(C)2006 JeraOne - http://www.jeraone.com