Cardio3 BioSciences’ publishes Phase II trial results for stem cell therapy treatment in the JACC and increases its equity by €19 million.

Biopharmacy Cell therapy Home_Spotlight — 24 May 2013

Two exciting new announcements have recently been made by Belgian-based biotechnology company Cardio3 BioSciences(Mont-Saint Guibert, Wallonia). In early April the company announced the publication of Phase II trial results for stem cell therapy C-Cure^® in the Journal of the American College of Cardiology(JACC¹) and just last week, announced that it has increased its equity by €19 million* through a private placement with existing investors. The new funds will be used to finance the on-going clinical development of the Company’s lead product currently tested in Europe and by allowing the company to proceed with its European Phase III (CHART-1 – Congestive Heart failure cardiopoietic** Regenerative Therapy) trial in patients with congestive heart failure (CHF).
The company, focused on the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, has recently published its advanced Phase II trial results that demonstrate possible next generation therapies for heart failure in the on-line edition of the Journal of the American College of Cardiology (JACC). The innovative cardiopoietic stem cell therapy treatment, the outcome of research conducted at Mayo Clinic (Rochester, Minnesota, USA), Cardio3 BioSciences (Mont-Saint-Guibert, Belgium) and Cardiovascular Centre Aalst (Aalst, Belgium) has shown statistically significant improvements in heart function and exercise-tolerance. This unique therapy allows the reprogramming of bone marrow cells into ‘cardiopoïetic’ cells with the aim of growing new heart tissue thereby repairing damaged heart muscle.
The publication concluded that the therapy with C3BS-CQR-1(C-Cure^®) was feasible and safe with signs of benefit in chronic heart failure, meriting further definitive clinical evaluation. The trial was a prospective, multicenter, randomized study designed to evaluate the feasibility, safety, and efficacy of its cardiopoietic stem cell therapy in the treatment of patients with chronic heart failure secondary to ischemic cardiomyopathy. As reported in the journal publication, the trial results have demonstrated significant improvement in cardiac function as well as significant improvement in 6-minute walk distance for the treated patients.

To further explain, the innovative therapy consists of the patient’s own stem cells harvested from the bone marrow and engineered to become progenitors of new functional cardiac cells; cells that behave identically to the cells lost to heart disease. In the Phase II trial, all patients received optimal standard-of-care for heart failure, while the treated group also received an intra-myocardial injection of the stem cell therapy.

Based on the outcomes of these trials and with the help of the significant funding recently acquired, C3BS can further proceed with its Phase III trial (CHART-1). The therapy is currently the first-of-its-kind in a Phase III trial worldwide using organ specified cells (pre-programmed cardiac progenitor cells) for the treatment of ischemic heart failure and will recruit approximately 240 patients, with chronic advanced symptomatic heart failure furthering Cardio3 BioSciences’ dedication and leadership in bringing regenerative therapies to patients.

In hopes of confirming the promising Phase II results in its Phase III trial, this will be the first pivotal Phase III study assessing such advanced regenerative product for the treatment of heart failure.

Principal Investigator for C3BS, Dr Jozef Bartunek, explains that the Phase II trial results ‘highlight the promise of such novel technology for optimized regenerative intervention in heart failure, bringing next generation therapies to patients and further explains that the follow-up Phase III trials underway, will bring the cardiopoietic approach ‘to the forefront of this exciting field’.

With the belief that the innovative science behind this stem cell therapy has the potential to revolutionize the treatment of this debilitating disease, this breakthrough treatment could be another great milestone for C3BS and further recognition of the scientific innovation being produced here in Belgium.

* Of the €19 million raised, €7 million is in new equity committed by existing investors with €12 million resulting from the conversion of existing convertible loans. The formal capital increase was approved at a shareholder meeting and is expected to complete by the end of May 2013.

**Cardiopoiesis: A proprietary process that reprograms non-cardiac cells to become cardiac precursor cells.(cells that could become fully functional cardiac cells if put in the right conditions like a heart itself)

1:Bartunek J, Behfar A, Dolatabadi D, Vanderheyden M, Ostojic M, Dens J, El Nakadi B, Banovic M, Branko B, Vrolix M, Legrand V, Vrints C, Vanoverschelde J-L, Crespo-Diaz R, Homsy C, Tendera M, Waldman S, Wijns W, Terzic A. Cardiopoietic stem cell therapy in heart failure. The C-CURE multicenter randomized trial with lineage-specified biologics. Journal of the American College of Cardiology 2013.

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