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Mesoblast Reports Phase 3 Trial Data Showing Substantial Reductions in Cardiac and Stroke Events in CHF Patients

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Shares of Mesoblast Ltd. traded 36% higher after the company reported positive results from its Phase 3 DREAM-HF study showing that a single dose of rexlemestrocel-L provided very significant decreases in heart attacks, strokes and cardiac death in patients diagnosed with chronic heart failure.

Allogeneic cellular medicines developer Mesoblast Ltd. (MESO:NASDAQ; MSB:ASX), which is focused on the development of off-the-shelf medicines to treat severe and life-threatening inflammatory conditions and diseases, today announced "additional results from the landmark DREAM-HF randomized controlled Phase 3 trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L (REVASCOR®) or control sham."

Mesoblast reported that in the DREAM-HF study patients treated with a single dose of rexlemestrocel-L experienced substantial and durable reductions in heart attacks, strokes and cardiac deaths. The firm stated that these very positive outcomes may form the basis of identifying a breakthrough in addressing primary unmet needs of patients suffering from chronic heart failure.

The company noted that in the Phase 3 DREAM HF trial of 537 patients with New York Heart Association (NYHA) class II or III chronic heart failure, the incidence of heart attacks and strokes was reduced by 60% after taking a single dose of rexlemestrocel-L. The firm added that patients who received rexlemestrocel-L experienced a 68% reduction in recurrent hospitalizations from non-fatal heart attacks or strokes compared to the control group. The firm additionally pointed out that the incidences of death from cardiovascular causes were significantly reduced in ischemic and non-ischemic subgroups as well as in both diabetic and non-diabetic patients.

The company advised that there were three prespecified endpoints measured in the study that were combined into a single composite outcome. This indicator sought to measure the occurrences of cardiac death, heart attack or stroke, which it noted is referred to as "the three-point Major Adverse Cardiovascular Event (MACE), a well-established endpoint used by the U.S. Food and Drug Administration (FDA) to determine cardiovascular risk." The firm pointed out that in the Phase 3 study rexlemestrocel-L significantly demonstrated 30% reductions in MACE scores versus the control group.

The company stated that "the ability of rexlemestrocel-L to significantly impact cardiac death, heart attacks and strokes on top of maximal HFrEF therapy reflects the unique mechanisms of action of this allogeneic cellular therapy on reduction of inflammation and improved microvasculature." The firm advised that after observing substantial reductions in mortality and morbidity in the Phase 3 rexlemestrocel-L trial it plans to enter into discussions with the FDA to regarding a potential approval pathway going forward.

Mesoblast explained that heart failure is presently increasing globally in prevalence and the number of incidences. The condition affects about 26 million people worldwide and around 6.5 million people in the U.S. The company stated that "chronic heart failure is a progressive disease associated with cardiac and systemic inflammation and a high mortality rate that approaches 50% at 5 years as patients progress beyond NYHA class II disease and that these patients are at high risk of recurrent heart attacks and strokes, reflecting the high degree of systemic inflammation and progressive atherosclerosis associated with chronic heart failure."

The firm stated that the Phase 3 DREAM HF Trial evaluated a total of 537 advanced HFEF patients. In the double blind study patients were randomized where half were given either a sham-control procedure (placebo) or a 150 million cell transendocardial injection by catheter of rexlemestrocel-L. In order to have been selected to participate in the trial, the patient subjects must have been previously diagnosed with advanced disease that required recent hospitalization and/or have registered an N-terminal pro–B-type natriuretic peptide (NT-proBNP) level of at least 1000 pg/ml. The firm indicated that "recurrent non-fatal decompensated heart failure hospitalization events, incidence of heart attacks, strokes, and death from cardiac causes, and recurrent hospitalizations from these outcomes were evaluated for the 537 HFrEF patients over a median follow-up period of approximately 30 months."

Mesoblast Ltd. is headquartered in Melbourne, Australia, and is a developer of industrial-scale, cryopreserved, off-the-shelf allogeneic cellular medicines addressing life-threatening inflammatory conditions. The company utilizes its proprietary mesenchymal lineage cell therapy technology platform to create a wide portfolio of commercial products and late-stage product candidates. The firm stated that "it is developing remestemcel-L for treating inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome." The company's other Phase 3 product candidates include MPC-06-ID for treating chronic low back pain due to degenerative disc disease and REVASCOR® for use in the treatment of advanced chronic heart failure. The company has offices located in Australia, the U.S. and Singapore.

Mesoblast began the day with a market cap of around $1.0 billion with approximately 117.2 million shares outstanding and a short interest of about 2.7%. MESO shares opened 49% higher today at $12.91 (+$4.25, +49.079%) over Friday's $8.66 closing price. The stock has traded today between $11.55 and $13.70 per share and is currently trading at $11.84 (+$3.18, +36.70%).

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