Can-Fite Namodenoson-Treated Liver Cancer Patient Heals All Cancer Lesions in Open-label Extension of Phase II Study
Beginning of the pivotal phase 3 study in the first quarter of 2022
PETACH TIKVA, Israel, December 20, 2021– (BUSINESS WIRE) – Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company developing a pipeline of proprietary small-molecule drugs that treat inflammatory, cancer and liver diseases, today announced that the latest patient treated under ‘an open-label extension program of its completed Phase II study of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer, has seen a complete response (CR) to the drug from Can- Fite, which means that all the cancerous lesions are gone.
On treatment with Namodenoson, the patient has now survived five years, during which clinical benefits of treatment included resolution of ascites, normal liver function and resolution of peritoneal carcinoma leading to complete resolution of all symptoms. cancerous lesions.
“The complete response of HCC at an advanced stage is a rare but very beneficial finding in the area of liver cancer treatment. We are delighted that Namodenoson has helped restore the health and quality of life of this patient and his family. We hope that our next pivotal phase III study will demonstrate the efficacy of Namodenoson in the treatment of patients with similar advanced stage HCC and thus potentially provide longer survival for patients with liver cancer through the world, ”said Can-Fite Medical Director Dr. Michael Silverman.
In the first quarter of 2022, Can-Fite plans to begin patient enrollment in its pivotal Phase III trial for Namodenoson in the treatment of patients with advanced HCC with underlying Child Pugh B7 cirrhosis (CPB7 ) to support a New Drug Application (NDA) submission and approval. The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both approved the study design of 471 patients. Namodenoson has orphan drug designation for HCC in the United States and Europe, has Fast Track status in the United States, and currently treats patients with liver cancer in a compassionate use program. in Israel.
Namodenoson is a small, orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson has been evaluated in phase II trials for two indications, as a second-line treatment for hepatocellular carcinoma and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells while low expression is found in normal cells. This differential effect explains the excellent safety profile of the drug.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical drug development company with a technology platform designed to address multi-billion dollar markets in the treatment of cancer, liver and inflammatory diseases . The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis. Can-Fite’s liver drug Namodenoson is heading into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of steatohepatitis non-alcoholic (NASH). Namodenoson has received orphan drug designation in the United States and Europe and expedited designation as a second-line treatment for HCC by the United States Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers, including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has been shown to be effective in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information, please visit: www.can-fite.com.
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