CEO Interview

Using Small Molecules to Solve Big Clinical Needs


Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of Psoriasis, liver cancer, NASH, and erectile dysfunction. Can-Fite’s intellectual property portfolio consists of 15 patent families issued and pending.

Specific oral therapy aimed at diseased cells

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CanFite unveils Phase III Clinical Trial Programs and Strategic Partnerships

Overview

Advanced Clinical Development Targeting Multi-Billion-Dollar Markets

Current Pipeline

Can-Fite has an advanced pipeline of proprietary compounds in phase 2 and 3 clinical development stage, which address autoimmune-inflammatory and cancer diseases. The company’s platform technology utilizes the Gi protein associated A3 adenosine receptor (A3AR) as a therapeutic target. A3AR is highly expressed in inflammatory and cancer cells where low expression is found in normal cells, suggesting that the receptor could be a unique target for pharmacological intervention. Targeting the receptor with synthetic and highly selective A3AR agonists, such as Can-Fite's compounds Piclidenoson and Namodenoson, induces anti-inflammatory and anti-cancer effects.

In addition, the receptor is suggested as a biological marker based on human clinical data showing that high receptor expression at baseline predicts improved patient response to treatment. Can-Fite’s novel therapeutic approach to liver and inflamatory diseases addresses multi-billion dollar markets.

  • Unique Platform Technology
    • Small molecule, orally bioavailable drugs.
    • Targeting the A3 adenosine receptor so pipeline drugs only bind to pathological cells, not normal cells.
    • Proven therapeutic effect with anti-inflammatory and anti-cancerous effects shown in Phase II and Phase III studies.
    • Excellent safety profile demonstrated in over 1,500 patients.

  • Advanced clinical stage drug development
    • Phase III Psoriasis study achieved primary endpoint, enrolling 400 patients with moderate-to-severe psoriasis. Patients treated with Piclidenoson had significant improvement in PASI scores (a measure of psoriasis severity) compared to the placebo.
    • Phase III liver cancer study will enroll 450 patients for Namodenoson. The drug has Orphan Drug status with both the FDA and European Medical Agency, as well as Fast Track Status for the treatment of hepatocellular carcinoma.
    • Namodenoson’s Phase IIa NASH/NAFLD double-blind placebo-controlled study met all efficacy and safety endpoints including anti-inflammatory effects, reduced liver fat content, inhibition of fibrosis, decrease in body weight, and demonstrated an excellent safety profile. NASH is an unmet medical need with no FDA approved treatment to date and a market projected to be worth $35-$40 billion by 2025.

  • Successful corporate partnerships and licensing deals
    • International out-licensing deals with Cipher Pharmaceuticals, Gebro Pharma, EWO Pharma, Kyongbo Pharmaceuticals, Chong Kun Dang Pharm, and China Medical Systems
    • Approximately $20 million received in upfront and milestone payments.
    • $130 million potential based on regulatory and sales milestones.

  • Accomplished Leadership Team
    • Dr. Pnina Fishman, Chief Executive Officer; very accomplished scientist and has authored or co-authored 170 publications and presented the findings of her research at many major scientific meetings. This scientific work has gained recognition as one of the leading approaches for next-generation therapies for cancer and other diseases.
    • Motti Farbstein, Chief Financial Officer; has more than 20 years of experience in finance and corporate compliance. Mr. Farbstein oversees corporate accounting, finance, tax, risk management/internal audit and plays a significant role in strategic leadership.
    • Dr. Sari Fishman, Vice President of Business Development; has fifteen years of combined experience in the biotechnology industry including ten years of employment as a Director of Clinical Trials in the fields of oncology, rheumatoid arthritis, psoriasis & ophthalmology and five years as a VP of Business Development in charge of deal sourcing, scientific assessments, term sheets, and contract negotiations.