Full Press Release Details
Updates: Namodenoson Increases Survival for the Most Severe Patients with Advanced Liver Cancer
PETACH TIKVA, Israel, December 28, 2022 -- 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 provided an update on its clinical program for Namodenoson in the treatment of
hepatocellular carcinoma (HCC), the most common form of liver cancer. A pivotal Phase III registration study is open for enrollment of
the most advanced liver cancer patients. At two upcoming bio-partnering conferences, Can-Fite will be presenting the latest data comparing
the response of liver cancer patients to those with HCC Child-Pugh B (CPB), the most advanced liver cancer. The Company will also share
the latest findings on a CPB liver cancer patient who remains cancer-free 6 years after she began treatment with Namodenoson.
Can-Fite's prior Phase II study showed that
median overall survival in the CPB7 patient population was 6.8 months for those treated with Namodenoson as compared to 4.3 months for
those treated with placebo. The < 1-year survival in the whole patient
population was 32% in the namodenoson treated group vs. 14% (p= 0.058) in the placebo treated patients whereas in the CPB7 population
44% survival was found in the namodenoson treated group vs. 18% in the placebo treated one (p=0.028). An article published in the peer-reviewed
journal Cancers regarding Can-Fite's Phase II study reported on the fact that CPB patients are generally excluded from clinical
studies due to their poor prognosis and low expected response rate and that as of July 2020, clinicaltrials.gov listed 110 enrolling/active
Phase II or III clinical studies in advanced HCC, all of which excluded CBP patients, except for only two studies in addition to Can-Fite's.
"There is a dire need for a safe and effective
treatment for patients with advanced liver disease, defined as CPB7 where Namodenoson has an advantage with its liver protective effect,"
stated Can-Fite CEO Dr. Pnina Fishman "Our Phase III pivotal Namodenoson study is open for enrollment of CPB7 patients who have
tried but not benefitted from other treatments on the market. We are optimistic that Namodenoson can help these patients based on the
overall survival benefit already demonstrated in our Phase II study. At the upcoming bio-partnering conferences, we will be sharing extensive
data that compares how the overall liver cancer population is treated, while the CPB patient population has few options and there are
very few drug developers that will even allow them into their studies."
Can-Fite has received agreement from both the
U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on its Phase III pivotal liver cancer study which is now open
for enrollment. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment
of HCC. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying CPB7 through clinical sites
worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary
efficacy endpoint of the trial is overall survival. 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.
An interim analysis will be conducted by an Independent
Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment
for CPB7 patients in whom other approved therapies have not been or are no longer effective.
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.
Conference Schedule:
Biotech Showcase: The Investor Conference for
Innovators - San Francisco, Sari Fishman Ph.D. will participate.
Meeting Dates: January 9-11, 2023
Location: Hilton San Francisco Union Square
For more information to request a meeting please
BIO CEO & Investor Conference - New
York, Motti Farbstein CFO will participate.
Meeting Dates: February 6-7, 2023
Location: New York Marriott Marquis
For more information to request a meeting please
Namodenoson is a small orally bioavailable drug
that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was 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, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported
topline results in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma
(HCC), the most common form of liver cancer. 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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to time in the "Risk Factors" section of Can-Fite's Annual Report on Form 20-F filed with the SEC on March 24, 2022
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