Can-Fite Updates on Status of Phase II Advanced Liver Cancer Trial
|·||Accumulated safety data to date continues to indicate a favorable drug safety profile without hepatotoxicity|
|·||Namodenoson has an Orphan Drug Designation in Europe and the U.S., as well as Fast Track Status in the U.S.|
PETACH TIKVA, Israel, June 19, 2018 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today provided an update on its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of advanced hepatocellular carcinoma (HCC) in patients whose disease has progressed on sorafenib therapy. Can-Fite anticipates analyzing the results of this important trial before the end of the current year.
The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.
The trial first opened to enrollment in December 2014 and enrollment of 78 patients was completed in August 2017. While the trial continues treating subjects in a blinded fashion (either Namodenoson 25 mg BID or matching placebo), Can-Fite notes that of the 78 subjects originally enrolled, 19 completed at least 12 cycles of treatment (each cycle is 28 days of treatment) of which three completed at least 24 cycles. The longest-treated subject has been receiving study medication for approximately 3 years.
Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.
Michael Silverman, MD, FACP, Can-Fite’s Medical Director says, “While the final analysis of this trial, based on survival, has been delayed past our original projections, we are very happy that the reason for this is the unexpected longevity of patients enrolled into this trial. Historically, HCC patients who have failed treatment with sorafenib and are Child Pugh B, have very limited life expectancy. Although the trial data are still blinded, we are encouraged by the unexpectedly long survival for some patients and hope that this will translate into a survival advantage for the Namodenoson group over the placebo group, and a critical advance for treating patients with HCC.”
Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being 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 whereas low expression is found in normal cells. This differential effect accounts for 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 stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis in 2018. Can-Fite's liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. 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 shown efficacy in the treatment of erectile dysfunction in preclinical studies and the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with experience in over 1,000 patients in clinical studies to date. For more information please visit: www.can-fite.com.
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