Expert exposes 'highly questionable' data from biotech Cardio3 after IPO

Last week Cardio3 BioSciences wrapped up a €23 million ($29.6 million) IPO, a deal that Forbes contributor Larry Husten argues was based on inconsistent data that he called "highly questionable." He cites an expert who drilled into Phase II data from a study of the Belgian biotech's cellular therapy for heart failure, highlighting miscalculations and suspicious activity in the execution and reporting of the study.

The company raised the IPO, valued at about $30 million, to fuel Phase III development of its C-Cure therapy that uses programmed cells to fix damaged tissue in heart-failure patients. The shares sold at the low end of the proposed offering range, at €16.65 ($21.43), yet, like a string of previous public debuts in biotech, the value of the shares has already jumped by double-digit percentages. In garnering investments for the offering, the company claimed to have succeeded in a midstage study of the treatment.

Yet new owners of Cardio3's stock might not have noticed what stem cell critic Darrel Francis pointed out to Husten. Here are a few of the glaring issues from the Phase II data published in the Journal of the American College of Cardiology (JACC):

  • There was shoddy reporting. The paper noted 48 randomized patients, while tables in the journal entry gave slightly lower figures. In addition, the company's website says there was 1:1 randomization in the study, but the paper shows that the ratio of treated versus control subjects was 2:1. And somebody seems to have miscalculated that 13 of 24 patients with high cholesterol on statins was 96%. It's 54%.
  • They also found that the company reported plans to use a specific scanning method of measuring the primary endpoint of heart function and then study authors revealed that another, less rigorous, approach was used in the study.
  • To top it off, the JACC paper reported that 6 out of 19 authors of the paper had financial ties to Cardio3 but failed to include company co-founder William Wijns among them.

"It's unclear what these errors mean," Husten wrote. "At best, they suggest sloppiness and haste (perhaps tied to the impending IPO.) At worst, they raise the possibility of cherry picking of patients and data sets and manipulation of rules and protocols to manufacture desired results."

- check out his Forbes article

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