OphthaliX completes patient enrollment in CF101 Phase II trial for treatment of glaucoma

OphthaliX Inc. (OTCQB:OPLI), a clinical-stage company focused on developing therapeutic products for the treatment of ophthalmic disorders and a subsidiary of Can-Fite BioPharma Ltd. (NYSE MKT:CANF), announced today that it has completed patient enrollment for its Phase II trial of CF101 in the treatment of glaucoma.

GlobalData estimates that the treatment market for glaucoma in the seven major markets was $2.4 billion in 2013 and will grow to approximately $3 billion by 2023. Most glaucoma drugs on the market today are generic eye drops. The key advantages of CF101 are its oral administration and excellent safety profile.

The Phase II trial is being conducted in Europe and Israel and full enrollment of 88 patients has been achieved. Top line results are expected in mid-2016. The study is being conducted with two cohorts. In the first cohort 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 second cohort, dosage was increased, with patients receiving 2 mg of CF101 and matching placebo, given orally every 12 hours for 16 weeks. The drug's mechanism of action has been validated in an article by a leading researcher from University College London in the UK, Dr. Cordiero, who showed that the A3 adenosine receptor (A3AR) agonist has a neuroprotective effect in the eye via inhibition of retinal ganglion cell apoptosis resulting in a significant decrease in intraocular pressure (IOP).

"Glaucoma is a substantial global market in which CF101 is one of only a few oral drugs in development. Oral drugs like CF101 have the potential to increase patient compliance and be more convenient for the patient," stated Dr. Pnina Fishman, Chairman and Interim CEO of OphthaliX. "In prior human clinical studies, we've seen that CF101 reduced IOP, the most important and only modifiable risk factor for glaucoma."

CF101 has an issued patent in the U.S. for the reduction of IOP, which expires in 2030. Several similar applications are pending in major global markets. OphthaliX has licensed the exclusive rights for the use and development of CF101 in the field of ophthalmic diseases from Can-Fite.