Shares of Can-Fite BioPharma Ltd. fell 26% on the news that a mid-stage clinical trial of liver cancer drug Namodenoson failed to meet its goal of improving survival.
For the main goal, the trial showed that patients taking Namodenoson actually survived for a shorter period of time than the placebo arm, 4.1 months versus 4.3 months, respectively.
The Israeli company said in a March 26 press release that Namodenoson did, however, show promise in one arm of the trial that examined patients who had a severe form of the disease and had previously failed prior treatments. Those patients survived for 6.8 months compared to 4.3 months on placebo. The trial also met a secondary goal of showing an objective response in patients at a rate of 9% in the Namodenoson arm, compared with 0% for placebo.
Can-Fite noted that all nine of the patients with the most severe form of liver cancer that were admitted into the trial were randomly assigned to the Namodenoson group, which the company said skewed the results of the trial.
Despite the overall failure, Can-Fite said the other data and secondary goals support moving the drug on to a phase 3 clinical trial.
Can-Fite CEO Pnina Fishman said that advanced liver cancer patients currently lack effective treatment options, so the results seen with Namodenoson in the severe disease patients are encouraging.
"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," Fishman said.
Namodenoson has been granted a fast track designation by the U.S. Food and Drug Administration, which expedites the review process for drugs that address a condition with a high unmet need.
Despite the assurance from Can-Fite's CEO, shares of the company plummeted below $1 to 94 cents as of 1:30 p.m. ET on March 26.