Benzinga | Oct 8, 2021 08:48AM EDT

Hope on the Horizon for Liver Cancer Patients as This Company's Namodenoson Drug Starts Pivotal Phase III Global Trial

Photo by National Cancer Institute on Unsplash

Liver cancer is a growing global health concern. Apart from the financial burden it places on patients and economies, the American Cancer Society has revealed that by the end of 2021, liver cancer will account for more than 700,000 deaths globally each year.

It is a leading cause of cancer deaths worldwide, claiming more lives yearly at an alarming rate. As scary as that number looks, it is more frightening that the prevalence of liver cancer has tripled since 1980.

The incidence rate of liver cancer in women increased by approximately 2% annually while remaining steady in men between 2013 and 2018. Even though the rate remained stable in men, they are about 3 times more likely to be diagnosed with the disease than women.

According to the American Cancer Society, liver cancer is much more common in sub-Saharan Africa and Southeast Asia than in the U.S. In many of these countries, it is the most common type of cancer. More than 800,000 people are diagnosed with this cancer each year throughout the world.

The most common type of primary liver cancer is Hepatocellular carcinoma (HCC). HCC occurs most often in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection.

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 GlobalData to reach $5.3 billion by 2029.

Several factors, like being overweight or obese, having a long-term hepatitis B virus or hepatitis C virus infection, smoking cigarettes, drinking alcohol or eating foods with aflatoxin, can increase an individual's risk of getting liver cancer.

The increasing death rates and higher chances of getting liver cancer have brought a pressing and unmet need for potent medication and treatment to save more lives. Not only is a remedy of utmost importance, but there is also a huge untapped market for HCC.

Hope on the Horizon

Enter Namodenoson from Israel-based clinical-stage biopharmaceutical company Can-Fite BioPharma Ltd. (NYSE:CANF) (TASE: CFBI). Results from Phase II trials conducted by the company show there is hope on the horizon for liver cancer patients.

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). It was evaluated in Phase II trials for 2 indications -- as a 2nd-line treatment for HCC and as a treatment for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic 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.

The Phase II study showed efficacy in HCC patients with underlying Child Pugh B7 (CPB7) -- the hardest to treat patients -- showing an overall survival superiority.

Namodenoson is headed into a pivotal Phase III global pivotal study for the treatment of HCC and a Phase IIb trial for NASH treatment.

Liver Cancer: Pivotal Phase III Under Preparation

As Can-Fite prepares to start the trial, below are some key highlights so far:

* United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) agreed on the Pivotal Phase III Study Protocol

* Interim analysis to be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of planned 450 patients are enrolled and treated

* Namodenoson will be evaluated as a 2nd- or 3rd-line treatment for advanced liver cancer patients in whom other approved therapies have not been or are no longer effective

* The primary endpoint is overall survival

* Orphan drug status -- granted by FDA and EMA

* Fast-track status -- granted by FDA

Can-Fite has built a reputation as an advanced clinical-stage drug development company with a platform technology designed to address multi-billion-dollar markets in the treatment of cancer, liver, inflammatory disease, and COVID-19. Read more about Can-Fite's technology here.

In November 2019, Can-Fite announced that it had initiated its compassionate-use program for the treatment of HCC. Read about the compassionate-use program here.

Other exciting news for the company is that Namodenoson has been granted orphan drug designation in the U.S. and Europe and fast-track designation in the U.S. for liver cancer. It has also shown proof of concept to potentially treat other cancers, including colon, prostate, and melanoma.

Summary of Other Key Standings of Can-Fite Biopharma Ltd.

* Intellectual property portfolio: The portfolio consists of 15 patent families issued and pending to protect the different indications.

* Corporate partnerships: Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $20 million received to date and potentially up to an additional $130 million plus royalties.

* Financially well-positioned: The company is well-positioned to conduct all its clinical development programs and general and administrative duties for less than 1 year.

Read more about Can-Fite's technology and other drug advancements here.