Can-Fite moves forward with advanced liver cancer therapy
May 6, 2019
The FDA granted both orphan drug designation and fast track status to Namodenoson, an advanced liver cancer therapy candidate from Can-Fite BioPharma, according to a press release.
Can-Fite recently announced results from a phase 2 study of Namodensson, in which the therapy increased overall survival in patients with hepatocellular carcinoma and Child-Pugh class B7 compared with placebo, although the trial did not meet its primary endpoint.
Despite not meeting the phase 2 primary endpoint, Can-Fite has a meeting with the FDA to review a plan for a phase 3 clinical trial.
“We look forward to our upcoming meeting with the FDA regarding our phase 3 study design,” Pnina Fishman, CEO of Can-Fite, said in the release. “We are hopeful that based on efficacy data in the largest subgroup of the patient population from our phase 2 study, we can move forward into a pivotal phase 3 trial for marketing approval with the guidance of the FDA.”
Namodenoson is a small orally bioavailable drug that binds to the A3 adenosine receptor. The therapy is also being evaluated as a treatment for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.