Multiple Shots On Goal: Can-Fite's Late-Stage Clinical Pipeline Hits Positive Results

Multiple countries are approving Can-Fite BioPharma Ltd. CANF CFBI ’s Namodenoson for compassionate use in patients with advanced liver cancer.

These countries, including Romania and Israel, seem to have acknowledged Namodenoson’s high efficacy and good safety record with anti-inflammatory and anti-cancer effects — in line with Phase II and Phase III studies conducted by the company.

Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5’- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR).

According to Can-Fite, the drug has a potent anti-cancer effect, particularly against hepatocellular carcinoma, and anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation and in a Phase IIa NASH study.

Interestingly, Namodenoson is not the only drug in the company’s pipeline that seems to be grabbing a lot of attention. Can-Fite is also conducting studies for Piclidenoson for treating psoriasis and CF602 for treating erectile dysfunction.

Can-Fite seems to have carved a niche for itself 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, and inflammatory disease.

Multiple Shots On Goal

The company’s lead drug candidate, Piclidenoson, recently reported topline results in a Phase III trial for psoriasis.

Namodenoson is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, is open for enrollment.

The drug 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.

Can-Fite says Namodenoson has shown proof of concept to potentially treat other cancers, including colon, prostate, and melanoma.

The company’s third drug candidate, CF602, reports suggest, has also shown efficacy in treating erectile dysfunction. These drugs, according to Can-Fite, have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.

Late-Stage Clinical Development Pipeline

The company’s late-stage clinical pipeline seems to be ticking all the right boxes. For example, Can-Fite recently reported that if the Phase III pivotal (registration) study for liver cancer meets its primary endpoint, then Namodenoson can be approved to treat it.

The Phase III pivotal (registration) study for psoriasis, it added, is now being prepared based on successful results from the most recent Phase III study of Piclidenoson, which showed the drug is safe and effective.

Lastly, the Phase IIb NASH study is now enrolling and treating patients, following a successful Phase IIa study.

Clearance Of Cancer In Patients Treated With Namodenoson?

On October 25, the company reported that a patient, a 61-year-old woman with hepatocellular carcinoma (HCC), the most common form of liver cancer, and moderate hepatic dysfunction Child-Pugh B (CPB7), participated in Can-Fite’s prior Phase II study.

The patient was in the Namodenoson arm of the Phase II study and continued treatment with Namodenoson for five years under an Open Label Extension Program. Treatment is ongoing under a Compassionate Use Program established in Romania in August of 2022.

This case report demonstrates that treatment with Namodenoson can lead to a complete and durable response in patients with HCC and CPB7.

Current Out-Licensing Deals

Can-Fite has out-licensed its drugs to companies such as Cipher Pharmaceuticals Inc. CPH (Canada), China Medical System Holdings (HKG: 0867) (China), Kyongbo Pharmaceutical Co Ltd. (KRX: 214390) (South Korea), Gebro Pharma (Spain, Austria, and Switzerland), and Ewopharma (Central Eastern Europe).

The company has already received $20 million in upfront and milestone payments and expects $130 million in revenues based on regulatory and sales milestones.

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