Full Press Release Details
MELBOURNE, Australia and NEW YORK, Nov. 23, 2015 (GLOBE NEWSWIRE) -- The Mesoblast Board and management are committed to delivering the Tier 1 product milestones as set out in the recent F-1 registration statement using the Company’s existing cash reserves, including the proceeds raised by listing on Nasdaq.
The Company’s Tier 1 product portfolio and anticipated milestones include the following:
By the end of 2015, we expect to announce six month results from the first cohort in the Phase 2 trial of our product candidate for biologic-refractory rheumatoid arthritis. Results from the second cohort are expected during the first half of 2016.
During the first quarter of 2016, we expect that our licensee JCR Pharmaceuticals Co. Ltd. will launch TEMCELL® Hs. Inj. (JR-031), its mesenchymal stem cell product for acute Graft Versus Host Disease (aGVHD) in Japan.
During the first quarter of 2016, we expect to announce the outcome of the first interim analysis of safety and efficacy from a Phase 3 trial of our product candidate for advanced congestive heart failure.
During the third quarter of 2016, we expect to announce top-line results from an interim analysis of a Phase 3 trial of our product candidate for aGVHD. This interim analysis may support a BLA filing by the end of 2016. We expect to complete recruitment of this Phase 3 trial in the fourth quarter 2016 and to have top-line results of the trial in the first quarter 2017.
During the third quarter of 2016, we expect to complete enrollment of the first Phase 3 trial of our product candidate for chronic low back pain.
It is important that investors are aware that under United States securities laws the Company must refrain until 7 December 2015 from publicly discussing aspects of the business outside what was already disclosed in the F-1 registration statement, unless there is a new and material event requiring disclosure under United States regulatory rules or the ASX continuous disclosure rules.
Mesoblast Limited (ASX:MSB) (NASDAQ:MESO) is a global leader in regenerative medicine. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates target advanced stages of diseases where there are highly unmet medical needs, including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncology/hematology conditions.
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mesenchymal stem cells