In January 2007, Can-Fite announced the enrollment of about 250 patients in a phase IIb rheumatoid arthritis (RA) clinical trial in the US, Europe and Israel, in which CF101 was given for a period of 12 weeks. The results of this trial are expected to be released this summer.
The company announced that additional preclinical studies are underway to facilitate the initiation of phase III trials shortly after the release of the phase IIb study results. These studies include the development of a new drug formulation, in-vivo assessments of the distribution of radio labeled drug, and others.
The success of the preclinical studies will enable patients that participate in future clinical studies with Can-Fite’s CF101 to take the drug for periods of six to 12 months or longer, as generally required in phase III clinical studies.
“The success of these toxicology studies is a major milestone in the development of CF101, which will enable the xompany to enter subsequent development phases and treat patients for prolonged periods of time. This will allow a more in-depth investigation of the beneficial effect of CF101 in various inflammatory diseases,” commented Pnina Fishman, CEO of Can-Fite.
In addition to the RA trial with CF101, Can-Fite has initiated concurrent clinical trials for two other indications, namely dry eye syndrome and psoriasis.