Date: 2015-04-26
Type of information: Clinical trial autorization
phase: 2
Announcement: clinical trial authorisation
Company: Can-Fite BioPharma (Israel) OphthaliX (USA - NY)
Product: CF101
Action
mechanism: adenosine receptor agonist. CF101 is an A3 adenosine receptor (A3AR) agonist, is a novel, first in class small molecule orally bioavailable drug which binds with high affinity and selectivity to the A3AR, which is known to be over-expressed in inflammatory cells. The drug acts as a neuro-protective agent and prevents apoptosis of retinal ganglion cells.
Disease: glaucoma
Therapeutic area: Ophtalmological diseases
Country: Bulgaria, Romania
Trial details:
Latest
news: * On December 15, 2014, Can-Fite BioPharma, a biotechnology company developing a pipeline of small molecule drugs that address inflammatory and cancer diseases, and its subsidiary, OphthaliX, jointly announced the receipt of an approval from the regulatory authorities in Bulgaria to initiate the enrollment of patients to the second cohort of the Phase II clinical study in glaucoma. OphthaliX plans to conduct the study in two European countries, Bulgaria and Romania. The approval in Romania is expected shortly. In the first cohort of this study, patients were treated with 1 mg CF101 and placebo. Blinded results from this cohort showed that the drug had a favorable safety profile and was well tolerated. In the current cohort, the CF101 dose will be increased to 2 mg based on positive linear interim data in Can-Fite\'s Phase II/III Psoriasis study. The rationale to treat glaucoma patients with CF101 stems from data in another ophthalmic study showing that CF101 lowered the intraocular pressure (IOP) in patient eyes. Subjects will be randomized to receive 2 mg CF101 or matching placebo, given orally every 12 hours for 16 weeks. The study data will be released upon completion of the 2 mg dose treatment group, and is expected to be announced during the second half of 2015. OphthaliX has the exclusive rights for the use and development of CF101 in the field of ophthalmic diseases, which includes a US patent for the reduction of IOP that expires in 2030. Increased IOP is the most important and only modifiable risk factor for glaucoma. As previously announced, OphthaliX received third-party validation of its technology for the utilization of A3 adenosine receptor agonists for lowering intraocular pressure and treating glaucoma that was published by Professor M. Francesca Cordeiro, a Professor of Glaucoma & Retinal Neuro-degeneration at the University College of London and Imperial College in London.
