A successful €23 million initial public offering (IPO) last week was based on highly questionable research, according to a group of UK physicians who have scrutinized the available data. In addition, one of the researchers, a prominent European cardiologist, failed to disclose in a key paper that he helped to start, and held a significant interest in, the company, Cardio3 BioSciences.
On July 4 Cardio3 BioSciences, a biotechnology company focusing on cardiac stem cell therapy, said that it had raised €23 million in an IPO on the NYSE Euronext Brussels and NYSE Euronext Paris. The company’s main product is called C-Cure, which it defines as “a unique cell therapy aimed at repairing damaged tissue and improving heart function, clinical outcomes and quality of life.” C-Cure uses uses pre-programmed cardiac progenitor cells to treat heart failure. As described by the company, “the supporting science is the result of Mayo Clinic innovation leading to advanced product development, manufacturing scale-up, and clinical trial execution by Cardio3 BioSciences catalyzed by ongoing collaboration facilitated through Mayo Clinic Ventures.”
The company plans to use the IPO money for a Phase III trial, following what the company describes as “positive Phase II results, recently published in the Journal of the American College of Cardiology.”
But the phase II results are a bit more complicated, according to Darrel Francis and colleagues (who last week published a paper highly critical of a different stem cell group). Francis et al have identified numerous errors in the paper which raise serious questions about the validity of the data and whether any useful conclusions can be drawn from the paper.
One striking finding– obvious once it has been pointed out– is that the authors report at different times different number of patients enrolled in the trial. The text of the paper says 48 patients were randomized, Figure 1 lists 47, and Table 1 lists 45 (42 men and 3 women).