Clinical

Cardio3 BioSciences Clinical and Pre-Clinical Programmes

Cardio3 Biosciences’ Cardiopoiesis platform is based on technology discovered at the Mayo Clinic, the number 2 hospital in the US second to John Hopkins, and number 2 in Heart and Heart Surgery, second to Cleveland Clinic. The Cardiopoiesis platform is designed to drive the differentiation of multipotent stem cells to the cardiac programme.

The power of the Cardiopoiesis platform can be illustrated by the following highlights from the Company’s clinical and pre-clinical work: an 18% increase in left ventricular ejection fraction (LVEF) versus baseline of Chronic Heart Failure patients (C-Cure) and a 70% reduction in infarct size in an acute myocardial infarction (heart attack) animal model (C3BS-GQR-1).

Cardio3 BioSciences is focusing its activity on demonstrating that its lead product candidate, C-Cure, is able to improve the condition of patients suffering from Chronic Heart Failure secondary to ischemic cardiomyopathy.  C-Cure is a stem cell product candidate derived from the patient’s own bone marrow and guided to cardiac lineage cells.

Cardio3 BioSciences announced in November 2010, positive six-month results from its Phase II clinical trial of C-Cure. The primary objective of this trial was to assess the safety and feasibility of C-Cure.

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 functional and clinical benefit.

C-Cure Study Summary :

• 45 patients with heart failure secondary to ischemic heart disease were recruited in Belgium and Serbia, and randomized to optimal medical care or optimal medical care plus C-Cure treatment. Demographic and clinical baseline data were similar between 24 controls and 21 patients treated with C-Cure.
• The study showed that delivery of C-Cure is feasible without peri-procedural complications. No evidence of cell-induced systemic toxicity or pro-arrhythmogenicity was observed.
• Cardiac structural and functional parameters, assessed by echocardiography at six months versus baseline showed the benefit of C-Cure treatment.
  • On average, left ventricular ejection fraction (LVEF) was significantly augmented over baseline in the C-Cure versus control cohort (5.2±0.6% versus 1±0.7%, p < 0.01), translating into a 18.1±2.3% relative increase in systolic function afforded by cell therapy.
  • Reduction of end-systolic volume was 3-times larger in the C-Cure group compared to the control group (from 171±9 to 150±9 mL, and from 167±8 to 159±8 mL, p=0.01, respectively).
  • In contrast to the control cohort, which displayed inter-individual variance, C-Cure treatment invariably led to a pattern of improved left ventricular function in all individuals at 6 months follow-up.
• The beneficial effects on cardiac structure and function in the C-Cure group translated into meaningful improved fitness. The 6-min walk test, an index of overall performance, increased from 396±26 at baseline to 449±35 m at six months in C-Cure (+52±19 m) patients while it decreased from 412±19 to 391±25 m (-21±14 m) in the control group between the same time points (p<0.01). To summarize, at 6 months post-therapy, C-Cure treated heart failure patients walked 73 meters more than patients that received optimal standard of care.