Full Press Release Details
Can-Fite Concludes Successful
Meeting with European Medicines Agency (EMA) Regarding Phase III Trial and Registration Plan for Namodenoson in the Treatment of
Following meetings with both the U.S.
FDA and EMA, Can-Fite is ready to submit its protocol and conduct one pivotal trial for registration in both markets
PETACH TIKVA, Israel, June 04, 2020 --
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule
drugs that address inflammatory, cancer and liver diseases, today announced it has successfully concluded a meeting with the Scientific
Advice Working Party (SAWP) of the European Medicines Agency (EMA) regarding Phase III development of its drug candidate Namodenoson
in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.
Namodenoson is Can-Fite's adenosine
A3 receptor (A3AR) agonist which has recently been shown to prolong median overall survival (OS) in a selected patient population
with HCC in a Phase II clinical trial. Can-Fite sought scientific advice from the EMA to complement previous input from the U.S.
Food and Drug Administration (FDA) in its recent End-of-Phase II meeting regarding plans for a Phase III registration trial of
Namodenoson in patients with HCC and Child Pugh Class B7 (CPB7) cirrhosis. Having completed its meeting with the SAWP, Can-Fite
now has sufficient regulatory input to conduct a registration trial in accordance with the requirements of both the U.S. and the
The planned trial, a randomized, double
blind, placebo controlled trial, will enroll approximately 450 patients with HCC and underlying CPB7 cirrhosis at multiple centers
worldwide. Patients will be randomized to oral treatment with either Namodenoson 25 mg or matching placebo given twice daily. The
primary efficacy endpoint of the trial is overall survival (OS), based on the favorable OS response seen in the Phase II trial
in patients with HCC and CPB7 cirrhosis. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and
median progression-free survival, as well as standard safety parameters, will be assessed.
"We appreciate the EMA's advice
which, combined with the input we received last October from the U.S. FDA along with recommendations from our academic key opinion
leaders, gives us excellent guidance for conducting a successful Phase III clinical and registration program," stated Can-Fite
CEO Dr. Pnina Fishman.
According to the American Cancer Society,
liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As
new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight
to reach $3.8 billion by 2027 for the G8 countries.
Namodenoson is a small orally bioavailable
drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second
line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication.
The drug recently concluded a Phase II trial which successfully achieved efficacy and safety endpoints in the 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 COVID-19. The Company's lead drug candidate,
Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Piclidenoson has been approved for a pilot
clinical trial in Israel to treat COVID-19 infected patients with moderate-to-severe symptoms. 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 successfully achieved
its primary endpoint in a Phase II trial 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. 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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