Key Developments: Mesoblast Ltd (MSB.AX)

MSB.AX on Australia Stock Exchange

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24 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Mesoblast Ltd announces improved outcomes using Mesoblast cells in end stage heart failure
Tuesday, 24 Jun 2014 09:19pm EDT 

Mesoblast Ltd:Says that trial results evaluating a low dose of Mesoblast's proprietary mesenchymal precursor cells (MPCs) in patients with end-stage or class IV New York Heart Association (NYHA) heart failure who receive a left ventricular assist device.The multi-center, randomized, placebo-controlled trial compared outcomes in 30 end-stage or NYHA class IV heart failure patients requiring LVAD mechanical support who received either a single low dose injection into damaged heart muscle of allogeneic, or off-the-shelf, MPCs or a placebo injection.The trial investigators concluded that administration of a low MPC dose appeared to be safe and there was a potential signal of efficacy.The trial results showed that a single low dose MPC injection was associated with increased ability to maintain circulation without LVAD support, reduced early mortality, and reduced rehospitalization rates compared with control injections.  Full Article

Mesoblast Ltd announces issue of ordinary share
Thursday, 1 May 2014 05:00pm EDT 

Mesoblast Ltd:Says issue of 293,400 fully paid ordinary shares.Shares were issued upon exercise of  options.Issued for total consideration of A$794,232.  Full Article

Mesoblast Ltd announces holding interest of The Capital Group Companies, Inc
Wednesday, 8 Jan 2014 05:14pm EST 

Mesoblast Ltd:Says that The Capital Group Companies, Inc has an interest in 18,116,901 ordinary shares of Mesoblast, representing 5.64 pct. of the total voting power.  Full Article

Mesoblast Ltd to issue new shares
Friday, 20 Dec 2013 12:54am EST 

Mesoblast Ltd:Says to issue 475,600 new ordinary shares upon the exercise of options.Says total consideration A$1,205,238.  Full Article

Mesoblast Ltd reports positive type 2 diabetes trial results
Tuesday, 3 Dec 2013 06:36pm EST 

Mesoblast Ltd:Says topline results from the phase 2 trial of its Mesenchymal Precursor Cells (MPCs) in subjects with type 2 diabetes.Says the results of the trial support the safety and tolerability of a single intravenous infusion of MPCs in type 2 diabetes.Says additionally, there was an improvement in glycemic control as evidenced by reduction in hemoglobin A1c (HbA1c).Says the Phase 2 randomized, single-blind, placebo-controlled, dose escalation trial was conducted across 18 sites in the United States.Says the trial evaluated the effects of a single intravenous infusion of 0.3, 1.0 or 2.0 million MPCs/kg or placebo over 12 weeks in 61 patients with a mean diabetes duration of 10 years.Says the MPCs were safe and well tolerated with no treatment-related adverse events, meeting the trial's primary endpoint.Says following a single intravenous MPC infusion, overall HbA1c levels were reduced over the 12-week study period when compared to placebo.  Full Article

Mesoblast Ltd's Cell Therapy Strengthens Native Heart Function In Patients With End-stage Heart Failure On Assisted Circulatory Support
Monday, 18 Nov 2013 05:22pm EST 

Mesoblast Ltd announced that patients with end-stage or New York Heart Association (NYHA) class IV heart failure who receive a surgically implanted left ventricular assist device (LVAD) heart pump to maintain circulation may obtain specific benefit to their native heart from a single dose of Mesoblast’s mesenchymal precursor cells (MPCs) injected directly into their heart during surgery, a multicenter team of researchers within the United States National Institutes of Health (NIH)-funded Cardiothoracic Surgical Trials Network (CTSN), led by Icahn School of Medicine at Mount Sinai, New York, have found. The results of the Phase 2 trial assessing the safety and efficacy of injecting a single dose of MPCs directly into the heart muscle of end-stage heart failure patients receiving an LVAD for either bridge-to-transplant or as a destination therapy were presented on November 18, 2013, at the American Heart Association Scientific Sessions 2013 being held in Dallas, Texas. The double-blind, placebo-controlled multicenter trial was performed across 11 sites in the United States, and randomized 30 end-stage heart failure patients 2:1 to receive either a single 25 million dose injection of MPCs or control media into the native heart at the time of LVAD implantation. LVAD weaning, defined as a transient reduction in pump speed for at least 20 minutes, was attempted in all patients at predetermined intervals to assess native myocardial function.  Full Article

Mesoblast Ltd's Mesenchymal Precursor Cells Induce Functional Recovery In Ischemic Stroke Model
Sunday, 10 Nov 2013 05:56pm EST 

Mesoblast Ltd announced positive preclinical trial results which demonstrated that its Mesenchymal Precursor Cells (MPCs) could improve functional recovery following a stroke. The trial results showed that a single intravenous injection of human MPCs significantly enhanced sensorimotor recovery when administered up to seven days after an ischemic stroke in rats. Additionally, in a sub-study, MPCs increased neuronal activity and reduced the volume of infarct tissue. In the study, 72 adult male nude rats underwent permanent right middle cerebral artery occlusion (MCAO) which resulted in focal right cerebral infarction and impairment of the contralateral sensorimotor function. Subjects were randomized into 6 groups of 12 animals, and injected intravenously with either media alone (controls) or 1 million human MPCs administered at 6, 12, 24 or 48 hours post-MCAO, or day 7 post-MCAO. A single dose of 1 million human MPCs administered intravenously at 6, 12, 24 or 48 hours post-MCAO significantly improved forelimb and hindlimb recovery compared to controls by day 30 (p<0.01 for all doses). Body swing was similarly improved. Notably, administration of MPCs as late as 7 days post-MCAO significantly improved both forelimb recovery and body swing compared to controls (p<0.01 for both parameters), to similar levels at day 30 as seen with earlier cell administration.  Full Article

FDA Clears Commencement Of Mesoblast Ltd's PHASE 3 Chronic Heart Failure Trial Using Cells
Wednesday, 30 Oct 2013 11:00pm EDT 

Mesoblast Ltd announced that the United States Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) filing made by Mesoblast’s development and commercial partner Teva Pharmaceutical Industries Ltd to commence a Phase 3 trial in patients with chronic congestive heart failure using Mesoblast's Mesenchymal Precursor Cells (MPCs). The IND was cleared by the FDA within the minimum 30-day period following submission, and patient recruitment is expected to begin shortly. The multi-center trial, which will be conducted by Teva, is planned to enrol approximately 1,700 patients and includes two interim analyses of efficacy and/or safety. The clinical protocol was designed after initial consultation with both the FDA and the European Medicines Agency. The Phase 3 trial design is a double-blinded, 1:1 randomized, placebo-controlled study evaluating a single dose of 150 million MPCs delivered via transendocardial injection catheter to the left ventricle of heart failure patients with New York Heart Association (NYHA) class II or III disease and an ejection fraction ≤ 40%. The primary efficacy endpoint of the trial is a time-to-first event analysis of heart failure-related Major Adverse Cardiac Events (HF-MACE), defined as a composite of cardiac related death or resuscitated cardiac death, or non-fatal decompensated heart failure events.  Full Article

Osiris Therapeutics Inc Announces Agreement For Sale Of Culture-Expanded MSCs Including Prochymal Worth Up To $100 Million Plus Royalties To Mesoblast Ltd's Subsidiary
Thursday, 10 Oct 2013 07:12pm EDT 

Osiris Therapeutics Inc announced that it has entered into an agreement with a wholly owned subsidiary of Mesoblast Ltd for the sale of Osiris' culture-expanded mesenchymal stem cell (ceMSC) business, including Prochymal, in a transaction worth up to $100 million in initial consideration and milestone payments. Additionally, Osiris will receive royalty payments on sales of Prochymal and other products utilizing the acquired ceMSC technology. Summary of the Transaction: Mesoblast has acquired the assets related to Osiris` ceMSC business; Osiris will receive $50 million in consideration for closing and delivery of its ceMSC assets; Osiris is eligible to receive up to an additional $50 million in payments upon Mesoblast achieving certain clinical and regulatory milestones; Mesoblast will assume all future development costs for the ceMSC business; Osiris will receive single to low double-digit royalties on product sales derived from the ceMSC technology; Osiris and Mesoblast have entered into a separate services agreement for continued product advancement and to ensure a seamless transition; Osiris has retained a license to all transferred intellectual property necessary to run its other businesses; and For Osiris, the transaction results in pro forma cash, investments and receivables of approximately $82 million. Osiris expects to record the closing and asset transfer consideration of $51 million in the fourth quarter of fiscal 2013.  Full Article

Mesoblast Ltd Does Not Recommend Final Dividend
Wednesday, 28 Aug 2013 11:48pm EDT 

Mesoblast Ltd announced that no dividends were paid during the course of the financial year. There are no dividends or distributions recommended or declared for payment to members, but not yet paid, during fiscal 2013.  Full Article

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