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Wired News - Mesoblast Announced Updated Data from Phase-3 and Phase-2b Clinical Trials of MPC-150-IM in Patients with Chronic Heart Failure

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LONDON, UK / ACCESSWIRE / April 20, 2018 / Active-Investors.com has just released a free research report on Mesoblast Ltd (NASDAQ: MESO). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=MESO as the Company's latest news hit the wire. On April 17, 2018, the Company announced an update on the Phase-3 DREAM-HF trial and Phase-2b clinical trials of the Company's proprietary allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in patients with moderate-to-severe and end-stage advanced chronic heart failure (CHF), respectively. Register today and get access to over 1000 Free Research Reports by joining our site below:


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Positive clinical signals have been previously published in Phase-2 trials of Mesoblast's MPC therapy in advanced and end-stage heart failure supporting a common underlying mechanism of action (MOA).

Phase-3 DREAM-HF Trial Targeting Patients with Moderate-to-Advanced Chronic Heart Failure

The objectives of the Phase-3 trial are to evaluate the ability of MPC-150-IM to reduce the primary endpoint of recurrent non-fatal heart failure-related major adverse cardiac events (HF-MACE) in patients with left ventricular dysfunction, as well as delay or prevent disease progression to end-stage HF and terminal cardiac events (TCE), defined as death, left ventricular assist device (LVAD) implantation, or cardiac transplant. In April 2017, an interim futility analysis of the recurrent non-fatal HF-MACE primary efficacy endpoint in the DREAM-HF's first 270 patients was reported successful. The trial met the pre-specified threshold for continuation.

In April 2018, the Data Monitoring Committee (DMC) for the Phase-3 trial undertook a scheduled review of available data from 465 randomized patients. The DMC recommended continuation of the trial without modification. Enrollment of this Phase-3 trial is expected to be completed by the end of 2018.

Phase-2b Trial Targeting End-State Heart Failure Patients with LVAD

In December 2017, based on prior Phase-2 trial results which suggested that Mesoblast's MPCs improved native heart function, prolonged time to re-hospitalization and improved early survival in patients with an LVAD, the United States Food and Drug Administration (FDA) granted Mesoblast Regenerative Medicine Advanced Therapy (RMAT) designation for its MPC therapy in the treatment of heart failure patients with left ventricular systolic dysfunction and an LVAD. The RMAT designation under the 21st Century Cures Act aims to expedite the development of regenerative medicine therapies intended for the treatment of serious diseases and life-threatening conditions, and also offers eligibility for priority review.

A 159-patient trial, funded by the National Institutes of Health (NIH) and the Canadian Institute of Health Research, and evaluating Mesoblast's investigational MPC cells as add-on therapy to LVADs has completed enrollment. The objectives of this Phase-2b trial are to confirm and extend the prior Phase-2 results. The Company is pursuing a potential accelerated entry pathway for MPC-150-IM into the cardiovascular market that may be provided by RMAT designation.

About Chronic Heart Failure

Heart failure (HF), often referred to as CHF, is when the heart is unable to pump sufficiently to maintain blood flow to meet the body's needs. Signs and symptoms commonly include shortness of breath, excessive tiredness, and leg swelling. Common causes of heart failure include coronary artery disease including a previous myocardial infarction (heart attack), high blood pressure, atrial fibrillation, valvular heart disease, excess alcohol use, infection, and cardiomyopathy of an unknown cause.

About MPC-150-IM

MPC-150-IM is a tier 1 product candidate which consists of 150 million mesenchymal precursor cells (MPCs) administered by direct injection into the heart muscle in patients suffering from CHF and progressive loss of heart function.

About Mesoblast Ltd

Founded in 2004 and headquartered in Melbourne, Australia, Mesoblast is a world leader in 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.

Stock Performance Snapshot

April 19, 2018 - At Thursday's closing bell, Mesoblast's stock declined 1.84%, ending the trading session at $5.88.

Volume traded for the day: 22.89 thousand shares.

Stock performance for year-to-date - up 0.68%

After yesterday's close, Mesoblast's market cap was at $580.12 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.


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