"Mortality can reach 85% in patients with liver and gut complications and, outside of Japan, there are currently no approved therapies available. MSC-100-IV is on the cusp of becoming an important new treatment option for these patients," she said.The successful outcome of the DSMB interim analysis using the trial's primary endpoint of Day 28 overall response is consistent with previously reported results in a pediatric Expanded Access Program (EAP) in children with steroid-refractory aGVHD. Results from this program, which evaluated MSC-100-IV in 241 children, were presented in February 2016 at the American Society of Blood and Marrow Transplantation annual meeting. Key findings in the EAP program were:
- An overall response rate of 65% in all children at day 28 when MSC-100-IV was used either as last-line or front-line therapy after steroid failure
- An overall response rate of 81% at day 28 when MSC-100-IV was used as front-line therapy following steroid failure
- An overall response rate of 65% and 62%, respectively, in patients with gastrointestinal and liver disease, who have the highest mortality risk
- A significantly improved survival at day 100 in children who achieved overall response at day 28 (82% vs. 39%, log rank p-value <0.0001)
Conference CallDr Kurtzberg and Mesoblast's Chief Medical Officer, Dr Donna Skerrett, are participating in a corporate update conference call beginning at 9:00 am Australian Eastern Daylight Time on Tuesday, November 15, 2016 / 5:00 pm Eastern Time on Monday, November 14, 2016.To access the call, dial 1 800 558 698 (toll-free Australia), 1 855 881 1339 (toll-free US), or +61 2 9007 3187 (outside of the US and Australia). The conference identification code is 912575. The live webcast can be accessed via: http://webcasting.boardroom.media/broadcast/58214386d5f1311b35bd36a6 There will be a slide presentation. Please log in approximately 15 minutes prior to the scheduled start time. About MesoblastMesoblast Limited (ASX:MSB) (Nasdaq:MESO) is a global leader in developing innovative cell-based medicines. 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 with high, unmet medical needs including cardiovascular diseases, immune-mediated and inflammatory disorders, orthopedic disorders, and oncologic/hematologic conditions. Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
For further information, please contact:Julie Meldrum Global Head, Corporate Communications Mesoblast Limited T: +61 3 9639 6036 E: email@example.com Schond GreenwayVP, Investor RelationsMesoblast LimitedT: +1 212 880 2060 E: schond.Greenway@mesoblast.com