XBiotech (XBIT) walked into the European Medicines Agency Thursday with a slide presentation filled with data and arguments aimed at persuading regulators there to approve the company's colon cancer drug Xilonix.
The XBiotech plan failed. The short Xilonix "oral explanation" meeting ended with EMA officials issuing a negative "trend" vote -- essentially a recommendation to reject Xilonix at the agency's next official meeting for drug reviews scheduled for May.
"We are disappointed by the outcome of the meeting," said XBiotech CEO John Simard, in a statement.
Simard should be the only person disappointed. Anyone else making an objective assessment of Xilonix's chances for European approval saw little hope. Based on the poorly conducted clinical trial submitted by XBiotech to the EMA, Xilonix showed an ambiguous effect on the lean body mass and quality of life of colon cancer patients compared to a placebo. The drug did not shrink tumors, nor did it improve survival of the patients.
XBiotech's efforts to shade Xilonix's clinical failings amounted to little more than hand waving when it mattered most. European regulators at the oral explanation meeting on Thursday were not fooled.
"The clinical relevance of this rather small difference in favour of treatment with MABp1 is questioned and not considered compelling," EMA's review team concluded.
[MABp1 is the scientific name of Xilonix. XBiotech used a new brand name for the drug, Hutruo, during Thursday meeting.]
EMA reviewers also said this Thursday: "Neither the sensitivity analyses of the individual co-primary endpoints, nor the analyses of secondary or exploratory endpoints provide any supportive evidence for efficacy in favour of MABp1."
A second phase III study of Xilonix colon cancer is underway, this one utilizing a much tougher overall survival primary endpoint. The likelihood of failure is high, it's just a matter of time.