Hope on the horizon for liver cancer patients as company drug Namodenoson enters pivotal Phase III global trial


photo by National Cancer Institute to Unsplash

Liver cancer is a growing global health problem. In addition to 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 worldwide each year.

It is one of the leading causes of cancer death worldwide, claiming more lives every year at an alarming rate. As frightening as that figure may sound, it is even more frightening that the prevalence of liver cancer has tripled since 1980.

The incidence rate of liver cancer in women has increased by about 2% per year while remaining stable in men between 2013 and 2018. Even though the rate has remained stable in men, they are about 3 times higher. 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 United States. 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 around the world.

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

HCC is generally aggressive with low survival rates. As new drugs that treat HCC effectively and safely are developed and approved, the HCC treatment market is estimated by GlobalData to be $ 5.3 billion by 2029.

Several factors, such as being overweight or obese, long-term infection with hepatitis B virus or hepatitis C virus, smoking cigarettes, drinking alcohol, or eating foods containing it. aflatoxin, may increase the risk of liver cancer.

Rising death rates and higher chances of contracting liver cancer have resulted in an urgent and unmet need for powerful drugs and treatments to save more lives. Not only is a cure of the utmost importance, but there is also a huge untapped market for HCC.

Hope on the horizon

Enter Israel-based clinical-stage biopharmaceutical company Namodenoson Can-Fite BioPharma Ltd. (US NYSE: CANF) (TASE: CFBI). The results of the company’s Phase II trials show that there is hope on the horizon for patients with liver cancer.

Namodenoson is a small, orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). It has been evaluated in phase II trials for 2 indications – as a second-line treatment for HCC 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.

The phase II study showed efficacy in patients with HCC with underlying Child Pugh B7 (CPB7) – the most difficult patients to treat – showing superior overall survival.

Namodenoson is moving towards a global pivotal phase III study for the treatment of HCC and a phase IIb trial for the treatment of NASH.

Liver cancer: Pivotal phase III in preparation

As Can-Fite prepares to begin the trial, here are some highlights so far:

  • An interim analysis will be conducted by an independent data monitoring committee (IDMC) after 50% of the planned 450 patients have been recruited and treated

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

  • The primary endpoint is overall survival

  • Orphan drug status – granted by the FDA and EMA

  • Expedited Status – Granted by FDA

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

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

Another exciting news for the company is that Namodenoson has achieved orphan drug designation in the United States and Europe and accelerated designation in the United States for liver cancer. It has also shown proof of concept for potentially treating other cancers, including colon, prostate, and melanoma.

Summary of other key rankings of Can-Fite Biopharma Ltd.

  • Intellectual property portfolio: The portfolio is made up of 15 families of patents issued and pending to protect the various indications.

  • Corporate Partnerships: Piclidenoson and Namodenoson have obtained licenses in selected territories with approximately $ 20 million received to date and potentially up to an additional $ 130 million plus royalties.

  • Well Positioned Financially: The company is well positioned to conduct all of its clinical development programs and general and administrative tasks for less than a year.

Learn more about Can-Fite’s technology and other drug advancements here.

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