Smartfish juice for the treatment of cancer cachexia in combination with chemotherapy

Smartfish AS is developing a Food for Special Medical Purpose (FSMP) product called Nutrifriend Cachexia (NFCax and commercial name Remune) aimed to reduce and counteract the damaging and often deadly outcome of cancer cachexia (muscle wasting syndrome in patients during chemotherapy treatment) and to improve quality of life in patients suffering from different cancer types. The Smartfish Remune product contains omega-3 in a juice blend with vitamins and proteins. No nutrition product to date has succeeded in demonstrating improved outcomes in this disease. The clinical study in non-small cell lung cancer (NSCLC) is completed and results show that patients treated with Remune tolerate their chemotherapy better than patients receiving another nutrition with the same amount of calories (comparator group). The randomized, double-blind, controlled clinical study demonstrated that Remune is well tolerated and has a good safety profile in (pre-)cachectic patients with NSCLC. Remune has positive impacts on vital signs, lipid profiles and show trends in improved chemotherapy tolerability. After one year 10 patients were deceased in the comparator group while only 4 had died in the Remune group. These results will now pave the way for commercialising Remune in the market and trigger further clinical development in cachectic populations.

The idea is to develop the next generation Food for Special Medical Purposes (FSMP) product(s) that; - Reduce and/or counteract the damaging and often deadly outcome of cachexia (muscle wasting syndrome in cancer patients during chemotherapy treatment) - Improve outcomes and quality of life in patients suffering from specific cancer types. The products that will be improved and documented will contain essential nutrients (marine omega-3 fatty acids, a polyphenol rich juice protecting the omega-3 from being oxidized, vitamin D3, protein and dietary fibre) known to exert a range of biological activities and influence cell function, immune functions and anabolic response etc. Through these effects, supplementation can directly influence cancer cells and the right combination of these nutrients can stimulate an anabolic response by counteracting factors involved in inducing and sustaining cancer cachexia. No FSMP product to date has tried to or succeeded in demonstrating improved outcomes in cancer cachexia. The project consists of the following parts: 1) Preclinical development aiming to document the safety and efficacy of using nutrients in cancer treatment and which cancer that would benefit most from the treatment 2) Preclinical development aiming to understand the mechanisms behind the effects in cancer cachexia. 3) Clinical development aiming to document the safety and tolerability in patients as well as establishing the optimal efficacy parameter for further development 4) Clinical development documenting the efficacy in cancer cachexia The outlined research activities will lead to a new product for management of cancer cachexia in most likely non-small-cell-lung-cancer. The product will be unique among clinical nutrition products in the market. A full launch is foreseen in 2018 based on pivotal data and further regulatory approvals.