Mesoblast Announce Heart Muscle Function Improved After Single, Lowest-Dose Injection Of "Off-The-Shelf" Stem Cells In Patients With Heart Failure
17 May 2009
Australia's regenerative medicine company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), announced positive three-month interim efficacy results from the first 20 patients enrolled in the Phase 2 heart failure trial of the proprietary allogeneic, or "off-the-shelf", adult stem cell product Revascor(TM).
Three months after receiving a single injection into damaged heart muscle of the lowest dose of Revascor(TM), patients with moderate-severe congestive heart failure demonstrated significantly improved heart muscle function.
The randomised, placebo-controlled Phase 2 trial is being run at multiple centres in the United States by Mesoblast's United States-based associated company Angioblast Systems Inc. The trial aims to compar! e one of three increasing doses of Revascor(TM) against standa! rd of ca re in up to 60 patients suffering from moderate-severe congestive heart failure, defined as a baseline ejection fraction (EF) 40% or lower by echocardiogram.
On the basis of the positive interim efficacy results and the excellent safety profile seen to date in the first group of patients receiving the lowest dose of Revascor(TM), the second group of patients set to receive the next higher dose is currently in active recruitment.
In the first 20-patient cohort, 15 were randomised to receive the lowest dose of Revascor(TM) and 5 were randomised to the control arm. While control patients with baseline EF 40 or below demonstrated an 11% mean decrease in EF over the first 3 months (mean EF values decreased from 31 to 27), patients with baseline EF 40 or below who received a single injection into damaged heart muscle of the lowest dose of Revascor(TM) showed a 37% mean increase in EF over this period (mean EF increased from 28 to 37, p=0.017). The 10-point me! an difference in absolute EF at three months between cell-treated and control patients was significant (p<0.05).
Patients with the most severe and advanced heart failure, defined as a baseline EF < 30 (9 patients treated with Revascor), had an even greater improvement in heart function, with mean increase in EF over three months of 50% (p=0.02).
Executive Director, Professor Silviu Itescu, said he was very encouraged by the three-month interim efficacy results seen after a single injection of the lowest dose of the proprietary allogeneic stem cells into damaged heart muscle.
"We eagerly await the six month results to see whether these effects are sustained or even further augmented," Professor Itescu said. "If the clinical trial continues to parallel our pre-clinical results, we anticipate even better outcomes in the next group of patients receiving a higher dose of Revascor(TM)."
International heart failure expert Professor Henry! Krum, Director of Monash University's Centre of Cardiovascula! r Resear ch & Education in Therapeutics, said, "These initial results are very exciting. Equally as important is the lack of any safety concerns to date, meaning that for the first time we could potentially have a safe and effective off-the-shelf cell therapy product which could change the treatment paradigm for patients with chronic heart failure."
Congestive heart failure remains a leading cause of hospital admissions, morbidity and mortality in the Western world. There are currently more than five million people in the United States suffering from congestive heart failure, with over 550,000 new cases annually. Despite major strides in prevention and treatment, heart failure is responsible for about 1.1 million hospitalisations in the US alone each year, and some 300,000 deaths. Total direct costs in the US exceed $US 33 billion annually.
Revascor(TM), a trademark of Angioblast Systems Inc, is an allogeneic cell therapy product being developed to reverse conge! stive heart failure by rebuilding both blood vessels and heart muscle.
Three-month results show safety and efficacy:
- Single injection into damaged heart muscle of the lowest dose of Revascor(TM), a proprietary allogeneic, or "off-the-shelf", adult stem cell therapy significantly improved heart function over three months in first group of patients with congestive heart failure
- Heart function significantly greater at three months in patients receiving Revascor(TM) compared with placebo-controlled, randomised controls
- Greatest improvement seen in patients with most severe heart failure
- No cell-related safety concerns
- Multiple United States hospitals actively recruiting second group of patients to be treated with next higher dose of cells
Source
Mesoblast Limited
17 May 2009
Australia's regenerative medicine company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), announced positive three-month interim efficacy results from the first 20 patients enrolled in the Phase 2 heart failure trial of the proprietary allogeneic, or "off-the-shelf", adult stem cell product Revascor(TM).
Three months after receiving a single injection into damaged heart muscle of the lowest dose of Revascor(TM), patients with moderate-severe congestive heart failure demonstrated significantly improved heart muscle function.
The randomised, placebo-controlled Phase 2 trial is being run at multiple centres in the United States by Mesoblast's United States-based associated company Angioblast Systems Inc. The trial aims to compar! e one of three increasing doses of Revascor(TM) against standa! rd of ca re in up to 60 patients suffering from moderate-severe congestive heart failure, defined as a baseline ejection fraction (EF) 40% or lower by echocardiogram.
On the basis of the positive interim efficacy results and the excellent safety profile seen to date in the first group of patients receiving the lowest dose of Revascor(TM), the second group of patients set to receive the next higher dose is currently in active recruitment.
In the first 20-patient cohort, 15 were randomised to receive the lowest dose of Revascor(TM) and 5 were randomised to the control arm. While control patients with baseline EF 40 or below demonstrated an 11% mean decrease in EF over the first 3 months (mean EF values decreased from 31 to 27), patients with baseline EF 40 or below who received a single injection into damaged heart muscle of the lowest dose of Revascor(TM) showed a 37% mean increase in EF over this period (mean EF increased from 28 to 37, p=0.017). The 10-point me! an difference in absolute EF at three months between cell-treated and control patients was significant (p<0.05).
Patients with the most severe and advanced heart failure, defined as a baseline EF < 30 (9 patients treated with Revascor), had an even greater improvement in heart function, with mean increase in EF over three months of 50% (p=0.02).
Executive Director, Professor Silviu Itescu, said he was very encouraged by the three-month interim efficacy results seen after a single injection of the lowest dose of the proprietary allogeneic stem cells into damaged heart muscle.
"We eagerly await the six month results to see whether these effects are sustained or even further augmented," Professor Itescu said. "If the clinical trial continues to parallel our pre-clinical results, we anticipate even better outcomes in the next group of patients receiving a higher dose of Revascor(TM)."
International heart failure expert Professor Henry! Krum, Director of Monash University's Centre of Cardiovascula! r Resear ch & Education in Therapeutics, said, "These initial results are very exciting. Equally as important is the lack of any safety concerns to date, meaning that for the first time we could potentially have a safe and effective off-the-shelf cell therapy product which could change the treatment paradigm for patients with chronic heart failure."
Congestive heart failure remains a leading cause of hospital admissions, morbidity and mortality in the Western world. There are currently more than five million people in the United States suffering from congestive heart failure, with over 550,000 new cases annually. Despite major strides in prevention and treatment, heart failure is responsible for about 1.1 million hospitalisations in the US alone each year, and some 300,000 deaths. Total direct costs in the US exceed $US 33 billion annually.
Revascor(TM), a trademark of Angioblast Systems Inc, is an allogeneic cell therapy product being developed to reverse conge! stive heart failure by rebuilding both blood vessels and heart muscle.
Three-month results show safety and efficacy:
- Single injection into damaged heart muscle of the lowest dose of Revascor(TM), a proprietary allogeneic, or "off-the-shelf", adult stem cell therapy significantly improved heart function over three months in first group of patients with congestive heart failure
- Heart function significantly greater at three months in patients receiving Revascor(TM) compared with placebo-controlled, randomised controls
- Greatest improvement seen in patients with most severe heart failure
- No cell-related safety concerns
- Multiple United States hospitals actively recruiting second group of patients to be treated with next higher dose of cells
Source
Mesoblast Limited