There’s more bad news to report for XBiotech $XBIT.
A few weeks after European regulators snubbed the company’s application to start marketing its dubious cancer drug Xilonix, the Austin-based biotech is back with the news that it’s halting a Phase III colon cancer study after outside experts concluded it wasn’t working.
The IDMC had no safety concerns from the unblinded analysis. However, the committee recommended the early termination of the study since the findings were not sufficient to meet efficacy or the threshold for continuation, which involved a prospectively defined acceptance boundary for the interim analysis of less than or equal to p = 0.08.
For the record, p=0.08 is a terrible score. Investors got the message fast, and drove XBiotech’s shares down by a capital crunching 62% Friday afternoon.
Very little about this drug, though, has gone right. Back in April the EMA’s Committee for Medicinal Products for Human Use flagged the members’ opinion that the data just wasn’t there for an approval. The formal CHMP opinion didn’t change. And its opinion was brutal.
The CHMP had a number of concerns. First, the committee noted that the study did not show clear improvements in either lean body mass or quality of life. Secondly, there was an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care. Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials.
Therefore, the CHMP was of the opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.
This was after investigators reported that the Phase III was marred by a mixup in treating the placebo and drug arms, a number of dropouts and improper patient evaluations.
XBiotech CEO John Simard, though, immediately began an appeal. And he’s not about to give up on this failed Phase III, either.
“We are obviously disappointed with these findings,” he said in a prepared statement. “In the coming weeks, the Company plans to analyze the data extensively to further understand the primary and secondary endpoint data, as well as to identify populations that may have benefited from the therapy. These findings today will not affect our efforts to pursue approval of the therapy based on the successful completion of the European study, which demonstrated control of debilitating symptoms in colorectal cancer.”
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