The Belgian biotechnology company, Cardio3 BioSciences - a leader in discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases - today announces positive six-month results, including significant functional and clinical benefit, from the Phase II clinical trial of its development programme C-Cure(R), 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;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. This difference in LVEF between the C-Cure treated and control patients was highly significant (p<0.0001).
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."
Dr. Jozef Bartunek, Associate Director of the Cardiovascular Center in Aalst, Belgium and Co-Principal Investigator of the C-Cure Clinical Trial added: "The data reported today are very positive for this 'first in man' trial using stem cells 'directed' to become heart cells. Early efficacy signals are impressive as they come on top of the optimal therapy currently available for patients with heart failure. The only difference between the two groups was the administration of C-Cure in the treatment group. C-Cure could ultimately represent a major step in advancing cardiac regenerative medicine, potentially offering a revolutionary treatment in patients suffering from heart failure, a devastating disease."
Prof. Andre Terzic, lead regenerative medicine specialist at Mayo Clinic in Rochester (MN), USA and Co-Principal Investigator of the C-Cure Clinical Trial commented: "Use of stem cells to seek to promote tissue repair in diseased hearts has the potential to transform medicine by providing curative solutions for the unmet needs of our patients. The C-Cure multicenter trial, which involved integrated teams on two continents, has introduced in the clinic the newest innovation under development in the field - namely the application of heart-prespecified stem cells in the treatment of heart failure. By translating a smart stem cell technology, known as "guided cardiopoiesis", into a first-in-class regenerative product candidate designed to be tailored to the individual patient, this study provides a critical step in our understanding of the feasibility, safety and efficacy of next generation cardiovascular medicine."
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.
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