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.