Can-Fite submits study details for FDA approval

Can-Fite has had an open investigational new drug (IND) for rheumatoid arthritis (RA) in the US since early January. Under this open IND the company is currently conducting a drug interaction study in RA patients with CF101 in combination with methotrexate (brand names include Stada Pharmaceuticals’ Rheumatrex and Barr’s Trexall), in preparation to the phase IIb study that is scheduled to begin within a few months.

The company’s phase IIb study will be a multi-national study that will be conducted in the US, Europe and Israel. A total of about 250 patients are expected to be enrolled in this study which will examine the efficacy of CF101 in combination with methotrexate in treating RA patients.

Professor Pnina Fishman, the CEO of Can-Fite said: “submission of the draft phase IIb protocol to the FDA within the framework of our IND, which was already approved by the FDA, is a major step towards the start of our phase IIb study. We trust that this study will provide a clear evidence for the efficacy of CF101.”

CF101 is a small molecule, which is administered to patients orally. This drug, which is developed for the treatment of rheumatoid arthritis, was tested to date in clinical trials in the US, UK and Israel. The drug is active against a wide variety of autoimmune and cancer diseases and has a preferential safety profile.

Can-Fite said the drug’s main advantage is in its ability to specifically attack pathological cells without affecting healthy ones. In addition, the fact that the drug is administered orally in the form of a capsule creates a huge advantage to current treatments which are administered by IV infusion or injection, at much higher costs.