Can-Fite BioPharma prepares for advanced phase clinical trials with CF101. Can-Fite announced the successful completion of long-term pre-clinical toxicology studies with its lead drug, CF101.
Studies were in full GLP compliance with US FDA and EMEA requirements. The success of these studies will enable patients that participate in future clinical studies with Can-Fite's CF101 to take the drug for periods of 6-12 months or longer, as generally required in phase III clinical studies.
In January 2007, Can-Fite announced the enrollment of about 250 patients in a phase IIb 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 pre-clinical 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.
Pnina Fishman, CEO of Can-Fite, said today that, "The success of these toxicology studies is a major milestone in the development of CF101, which will enable the Company 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."
In addition to the RA trial with CF101, Can-Fite has initiated concurrent clinical trials for two other indications of CF101, namely Dry Eye syndrome and Psoriasis, the latter of which was announced about 2 weeks ago.
In addition to CF101, which was included in the first commercial contract signed with the Japanese Siekagaku Corporation, under the terms of which Can-Fite has already received about USD 5 million, Can-Fite also develops CF102 for the treatment of Liver Cancer and Hepatitis B.