Cardio3 BioSciences Announces Positive Outcome of the C-Cure® Phase II Clinical Trial in Heart Failure Patients
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The Belgian biotechnology company, Cardio3 BioSciences, announces positive six-month results, including significant functional and clinical benefit, from the Phase II clinical trial of its development programme C-Cure®, designed as a novel stem cell therapy for heart failure based on breakthrough technology.
Forty-five patients with severe heart failure of ischemic origin participated in the C-Cure multicenter Clinical Trial in Belgium, Serbia and Switzerland, and were randomized to optimal standard of care (control group; n=24) or optimal standard of care plus C-Cure treatment (treatment group; n=21). The primary objective of this trial was to assess the safety and feasibility of C-Cure, a stem cell product candidate derived from the patient’s own bone marrow and guided to cardiac lineage cells.
Beyond meeting the safety objective as assessed by an independent safety board, the trial revealed that six months after receiving C-Cure, patients in the treatment group showed significant improvements in a number of measures of their heart function.
Patients receiving the trial drug C-Cure saw an 18.1% increase in left ventricular ejection fraction (LVEF) over baseline at the six month follow-up point, as measured by echocardiography, while the mean LVEF increased only by 3.6% in patients enrolled in the control group.
The trial also generated data that suggest favorable remodelling of heart muscle and improved heart muscle performance in the treatment versus control group. Signs of functional improvement were supported by improved fitness, shown by a significant mean difference in the 6-minute walking distance test between the treatment and control groups.
In terms of feasibility, the bone marrow of 70% of the attempted 30 patients was successfully processed into C-Cure. The company is targeting even further increasing this successful rate to 80% in its Phase III clinical program.
Dr. Christian Homsy, CEO of Cardio3 BioSciences said: “The highly promising data we report today build on the favourable safety profile we have observed through this Phase II trial and documents in patients our belief that we have with C-Cure a product candidate with the potential to make a real difference in the treatment of heart failure. It is important to note that the improvements in heart function suggested by the trial, were identified in the context of a Phase II trial aimed at assessing the safety and feasibility of C-Cure therapy. It is all the more encouraging to have seen significant differences in some key efficacy indicators despite the fact that the study was not powered, in terms of the number of patients, to demonstrate efficacy.”
“As noted in the company’s press release of 29 June 2010, with the Phase II stage completed and to allow for potential modifications to the trial protocol, Cardio3 BioSciences has not proceeded to Phase III recruitment into the trial but has continued to gather all data for the six month analysis.”
“Through the Phase II trial, we gained significant experience in working with a highly innovative stem cell therapy in a clinical setting, and we are using this acquired knowledge in the design of our planned Phase III programme. Cardio3 BioSciences is committed in taking the steps needed to bring to patients a new treatment for a condition where current therapies do not address the underlying cause of the disease.”
Using the insights from the trial and input from regulatory agencies in Europe and the United States, Cardio3 BioSciences is now designing a clinical trial programme for C-Cure expected to start in 2011.
Forty-five patients with severe heart failure of ischemic origin participated in the C-Cure multicenter Clinical Trial in Belgium, Serbia and Switzerland, and were randomized to optimal standard of care (control group; n=24) or optimal standard of care plus C-Cure treatment (treatment group; n=21). The primary objective of this trial was to assess the safety and feasibility of C-Cure, a stem cell product candidate derived from the patient’s own bone marrow and guided to cardiac lineage cells.
Beyond meeting the safety objective as assessed by an independent safety board, the trial revealed that six months after receiving C-Cure, patients in the treatment group showed significant improvements in a number of measures of their heart function.
Patients receiving the trial drug C-Cure saw an 18.1% increase in left ventricular ejection fraction (LVEF) over baseline at the six month follow-up point, as measured by echocardiography, while the mean LVEF increased only by 3.6% in patients enrolled in the control group.
The trial also generated data that suggest favorable remodelling of heart muscle and improved heart muscle performance in the treatment versus control group. Signs of functional improvement were supported by improved fitness, shown by a significant mean difference in the 6-minute walking distance test between the treatment and control groups.
In terms of feasibility, the bone marrow of 70% of the attempted 30 patients was successfully processed into C-Cure. The company is targeting even further increasing this successful rate to 80% in its Phase III clinical program.
Dr. Christian Homsy, CEO of Cardio3 BioSciences said: “The highly promising data we report today build on the favourable safety profile we have observed through this Phase II trial and documents in patients our belief that we have with C-Cure a product candidate with the potential to make a real difference in the treatment of heart failure. It is important to note that the improvements in heart function suggested by the trial, were identified in the context of a Phase II trial aimed at assessing the safety and feasibility of C-Cure therapy. It is all the more encouraging to have seen significant differences in some key efficacy indicators despite the fact that the study was not powered, in terms of the number of patients, to demonstrate efficacy.”
“As noted in the company’s press release of 29 June 2010, with the Phase II stage completed and to allow for potential modifications to the trial protocol, Cardio3 BioSciences has not proceeded to Phase III recruitment into the trial but has continued to gather all data for the six month analysis.”
“Through the Phase II trial, we gained significant experience in working with a highly innovative stem cell therapy in a clinical setting, and we are using this acquired knowledge in the design of our planned Phase III programme. Cardio3 BioSciences is committed in taking the steps needed to bring to patients a new treatment for a condition where current therapies do not address the underlying cause of the disease.”
Using the insights from the trial and input from regulatory agencies in Europe and the United States, Cardio3 BioSciences is now designing a clinical trial programme for C-Cure expected to start in 2011.
