Israeli biotech Can-Fite missed the primary endpoint in a midstage test of its experimental late-stage liver cancer drug namodenoson.
The FDA fast-tracked drug was seeking to achieve a boost in median overall survival across 78 patients with varying forms of advanced liver cancer, but in top-line data published today, the biotech said it failed to meet this primary endpoint.
But this has not dissuaded Can-Fite, which dug deep into the data and found a subpopulation of 56 patients using namodenoson (n = 34) that had a median overall survival of 6.8 months, versus 4.3 months in the placebo group (n = 22).
The biotech added that for this subgroup of patients, progression-free survival was 3.5 months for the namodenoson-treated group, versus 1.9 months in the placebo group.
The biotech also said that all nine patients with the most severe form of liver cancer in the test were randomly assigned to the namodenoson treatment group, a fact “which has distorted the results in the whole population,” it complained.
It said that the data, while a failure, still “strongly supported the progression into phase 3.”
“We are encouraged by the advantage shown by namodenoson in the CPB7 HCC population, a group for which there are no drugs with proven effectiveness,” said Pnina Fishman, Ph.D., CEO of Can-Fite. “Since namodenoson has a favorable safety profile and shows no evidence of hepatotoxicity, it may possess a unique therapeutic index in this high-need population. Given that namodenoson has been granted Fast Track status by the FDA, we look forward to engaging regulatory authorities in a dialog at the earliest opportunity.”
Despite trying to dig out the positive, Can-Fite shares were halved premarket on the NYSE, before settling at being around 33% down. It was down 26% on its local stock exchange in Tel Aviv.
The A3 adenosine receptor agonist was originated by researchers at the National Institutes of Health. Last summer, Can-Fite delayed publication of the data from this trial, saying at the time that the delay was due to “the unexpected longevity of patients enrolled into this trial,” according to its medical director, Michael Silverman, M.D.
The drug is also in trials for nonalcoholic steatohepatitis, a common noncancerous liver disease with no FDA-approved treatments, as well as earlier-stage studies in colon, prostate and skin cancer. The NASH study is due to generate results this year.