Introduction

The present invention relates to a method of anticancer treatment, and more specifically to a composition and method of treatment of hepatocarcinoma and liver metastases based on the combination therapy of sorafenib and regorafenib with proteoglycan protein-4 (PRG4), in particular with the recombinant form of human proteoglycan protein-4 (rhPRG4). The invention is based on the unexpected observation that the combination of recombinant human proteoglycan protein-4 (rhPRG4) and sorafenib and/or regorafenib is capable of synergistically increasing the efficacy of the two anticancer drugs, which is particularly useful for the treatment of those forms of hepatocarcinoma that are resistant to treatment with the first- and second-line therapeutic agents sorafenib and/or regorafenib.

Technical features

The invention relates to a pharmaceutical composition intended as a therapeutic product in which sorafenib and/or regorafenib and rhPRG4 are present in clinically effective amounts. Additional chemotherapeutic agents may also be included in the pharmaceutical composition. The patent provides for various methods of administration: 1.) Administration of sorafenib and/or regorafenib and rhPRG4 in a single dosage form, such as a tablet or an oral suspension; 2.) Sorafenib and/or regorafenib and rhPRG4 administered in different dosage units where soarefenib and regorafenib are administered orally and rhPRG4 is administered intravenously. The dosage of the therapy components and the duration of treatment according to the present invention are adapted by the physician depending on the patient’s condition and response. Importantly, the combination of sorafenib and/or regorafenib and rhPRG4 can be used as adjuvant, neoadjuvant, concomitant or palliative therapy, as first-line or crossover therapy. The exploitation of the present invention could result in the interest of a pharmaceutical company to develop the formulation in the best route of administration.

Possible Applications

• Treatment of hepatocellular carcinoma, liver metastases and forms of cancer resistant to treatment with sorafenib and/or regorafenib.

Advantages

• The combination of rhPRG4 and sorafenib and/or regorafenib can synergistically enhance the efficacy of the two anticancer drugs.
• The different modes of administration make the pharmaceutical composition ideal for a customised treatment plan.
• The combination of sorafenib and/or regorafenib and rhPRG4 can be used as adjuvant, neoadjuvant, concomitant, or palliative therapy, as first-line therapy, second-line therapy or crossover therapy.