Full Press Release Details
PHASE 3 HEART FAILURE TRIAL SIZE TO BE SUBSTANTIALLY REDUCED FOLLOWING FDA DISCUSSIONS
New York, USA; and Melbourne, Australia; 11 January 2016: Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that the size of the ongoing
Phase 3 trial in chronic heart failure (CHF) of its proprietary cell-based medicine MPC-150-IM is planned to be substantially reduced. This follows communications last month between Mesoblast s development and commercial partner, Teva
Pharmaceutical Industries Ltd., and the United States Food and Drug Administration (FDA).
Mesoblast Chief Executive Silviu Itescu said: The
reduction in the size of the Phase 3 trial may significantly shorten the time to trial completion.
The ongoing Phase 3 program is planned to be
optimized as follows:
In the completed Phase 2 trial, patients treated with MPC-150-IM had no HF-MACE over 36 months of follow-up, compared with 11 HF-MACE events in the control
group (p<0.001, log rank test). In patients with advanced heart failure as defined by baseline Left Ventricular Systolic Volume >100ml, who closely resemble the patients being recruited in the Phase 3 trial, 71% of controls had at least one
HF-MACE event vs 0 of those who received a single injection of MPC-150-IM (p<0.001).
Patients with advanced heart failure continue to represent
among the largest unmet medical needs, where existing therapies are inadequate and the economic burden is the greatest. The current Phase 3 trial targets this patient population, continues to recruit well across North America, and is now expanding
to Europe, Dr Itescu added.
Chronic Heart Failure
CHF is characterized by an enlarged heart and insufficient blood flow to the organs and extremities of the body. The condition is progressive and can be caused
by many factors that put an excess demand on the heart muscle such as high blood pressure, faulty valves, infections or congenital heart problems. The American Heart Association reports 5.7 million adults in the United States with diagnosed
CHF, or about 2% of the adult population, with 870,000 new cases diagnosed each year. New York Heart Association Class II / III CHF patients with low ejection fraction continue to be at high risk of repeated hospitalizations and mortality, despite
standard of care pharmacological treatments. CHF prevalence is expected to increase by 46% by 2030, affecting more than 8 million Americans. The estimated annualized cost for CHF is approximately $32 billion, and is projected to grow to $77
Mesoblast Limited (ASX: MSB; Nasdaq: MESO) is a global leader in 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 where there are highly unmet medical needs, including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncology/hematology conditions.
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