Cell Therapy News/Articles, page-197

https://m.nasdaq.com/article/will-meso-have-a-blast-this-quarter-20180823-00122


Will MESO Have A Blast This Quarter?


(RTTNews.com) - The American depository shares of Australian company Mesoblast Limited ( MESO ) have returned a mere 2% year-to-date, lagging behind the iShares Nasdaq Biotechnology ETF ( IBB ) Index's gain of nearly 10%.

Mesoblast is a global cellular medicines company, with a diverse portfolio of product candidates. The Company has two marketed products, three phase III product candidates, and a couple of products in phase II development.

The two marketed products include TEMCELL Hs. Inj. which is approved in Japan, for treatment of acute Graft Versus Host Disease, and Alofisel, which has central marketing authorization approval in Europe, for the treatment of perianal fistulae.

The phase III clinical programs include:
-- MSC-100-IV as first line treatment for in children with steroid refractory acute Graft Versus Host Disease
-- MPC-150-IM for patients with moderate-to-advanced chronic heart failure and
-- MPC-06-ID for Chronic Low Back Pain.


Also in the pipeline are:
-- MPC-150-IM, under phase IIb trial targeting end-state heart failure patients with a left Ventricular Assist Device
-- MPC-300-IV, being developed for biologic-refractory rheumatoid arthritis and for the treatment of diabetic complications, including diabetic kidney disease known as diabetic nephropathy
-- MPC-25-IC for the treatment of acute myocardial infarction, a phase II product candidate
-- MPC-25-Osteo for spinal fusion, a proprietary phase III-ready product candidate and
-- MPC-75-IA for the prevention of radiographic and clinical features of knee  osteoarthritis after traumatic injury, which has successfully completed a phase IIa trial.


Near-term Catalysts:
-- The Day 180 survival results from the phase III study of MSC-100-IV (Remestemcel-L) for acute Graft Versus Host Disease are expected to be reported this quarter.

The phase III trial, the results of which were reported in February of this year, successfully met its pre-specified primary endpoint of Day 28 overall response rate, which was 69%, a statistically significant increase compared to the theoretical control rate of 45%.
Key secondary endpoints of the phase III acute Graft Versus Host Disease trial include survival at 100 days, and safety and survival through 180 days.

According to the results of 100 day survival, which were announced in June of this year, the overall survival at Day 100 was 75%, and survival at Day 100 for responders at Day 28 was 87%.
If all goes well as planned, the Company intends to file a Biologics License Application for MSC-100-IV as first line treatment for children with steroid refractory acute Graft Versus Host Disease in Q4, 2018/Q1, 2019.
-- 12 month data read-out from the phase IIb trial MPC-150-IM in end-state heart failure patients with a left Ventricular Assist Device is expected to be reported this quarter (Q3,CY18).

Recent Deal:
Last month (July), Mesoblast inked a strategic alliance with one of China's largest pharmaceutical companies, Tasly Pharmaceutical Group, for the development, manufacture and commercialization of MPC-150-IM for the treatment or prevention of chronic heart failure, and MPC-25-IC for the treatment or prevention of acute myocardial infarction in China.
MESO has traded in a range of $4.74 to $7.79 in the last 1 year. The stock closed Wednesday's trading at $6.00, up 2.39%.