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Can-Fite BioPharma Ltd. CANF announced that the continued treatment of a patient, previously enrolled and treated with namodenoson in its phase II liver cancer study, observed a complete response and overall survival (OS) of 6.9 years (82.8 months).
The patient, at the time of enrollment in the phase II study, was suffering from advanced hepatocellular carcinoma (HCC). The patient continues to receive treatment with namodenoson, to date. Several observations were made in the condition of the patient, such as the disappearance of ascites, normal liver function and good quality of life, collectively defined as a complete response, along with the OS of 6.9 years.
Liver Cancer, designated as HCC, is caused by tumor growth on the liver with a high mortality rate. HCC is a major global health problem due to the lack of effective treatment modes, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B.
Can-Fite’s stock gained 6.7% on Tuesday as investors cheered the encouraging response observed in the liver cancer patient upon continued treatment with namodenoson. Year to date, shares of CANF have plunged 65.1% compared with the industry’s 12.6% decline.
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Namodenoson is the company’s small and orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor.
Currently, Can-Fite is enrolling patients in its pivotal phase III study of namodenoson for the treatment of advanced HCC, following agreements with regulatory bodies in the United States and EU. The investigational candidate enjoys Orphan Drug status in the United States and EU. Furthermore, the FDA has also granted Fast Track status to namodenoson.
The pivotal phase III study of namodenoson is expected to enroll 450 HCC patients with underlying Child Pugh B7 (CPB7). The enrolled patients will be randomized to receive either an oral and twice-daily 25 mg dose of namodenoson or placebo.
The primary endpoint of the pivotal late-stage study of namodenoson in HCC is that of OS. Other efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed.
After treating 50% of enrolled patients in the pivotal study with namodenoson, an independent committee will conduct an interim analysis. The candidate will be evaluated as a second or third-line treatment for CPB7 patients who have not benefitted from other approved therapies.
Can-Fite believes that namodenoson has the potential to get conditional approval, subject to positive results from the interim analysis of the phase III HCC study.