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Can-Fite BioPharma Receives Israeli MoH Approval to Conduct a Phase II Clinical Trial Evaluating the Efficacy of CF101 in Patients with Glaucoma

Can-Fite BioPharma Ltd (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, received approval from the Israeli Ministry of Health (MoH) to conduct phase II clinical trial with orally-administered CF101 in the treatment of Glaucoma. Leading Medical Centers in Israel will enroll 40 patients with Glaucoma for the first cohort and will be treated for 16 weeks with CF101 or placebo. The study will be expanded to 2 additional cohorts upon successful conclusion of an interim analysis of the first cohort. The study will investigate the safety and efficacy of CF101 manifested by a decrease in the intraocular pressure. The trial protocol and the results will also be reported to the US FDA.

The rationale for the conductance of this study is based on interesting findings from the recently concluded Phase II study in Dry Eye, demonstrating a decrease in the intra ocular pressure in patients who were treated with CF101.

Glaucoma is one of the leading causes for blindness and currently about 90 million patients worldwide are affected by the disease. The main treatments today consist of eye drops, which are not easy for patients use regularly and thus raise compliance challenges. Therefore, there is a market need for a systemic, orally administered drug such as CF101. The market size today is $5.5 Billion and is estimated to grow to around $8.4 Billion in 2012.

Can-Fite's CF101 is a targeted drug that specifically attacks diseased or pathologic cells without compromising normal body systems, and therefore has shown a favorable safety profile to date. CF101 is based on a scientific concept suggesting that the target of the drug (A3 adenosine receptor) is highly expressed on the surface of pathologic cells.

Prof. Pnina Fishman, CEO of Can-Fite, said today: "Oral tablets could free patients from recurrent use of eye drops and enhance treatment efficacy. We hope and believe that CF101 will be proven effective in the treatment of Glaucoma, based on the interesting finding that the drug decreased IOP in the dry eye syndrome patient population. We do hope that the drug will provide relief to millions of patients."

Can-Fite, whose shares were first issued in September 2005, has evolved within a short period of time to a company which develops couple of indications in the ophthalmic arena including Glaucoma, Dry Eye Syndrome and Uveitis, with an overall market of $8B.

CAN-FITE BIOPHARMA LTD is a public company listed on the Tel Aviv Stock Exchange. The Company, which commenced business activity in 2000, was co-founded by investigator Prof. Pnina Fishman and patent attorney Dr. Ilan Cohn. The Company focuses on the development of molecule-based drugs that inhibit the development of cancer and inflammatory cells. The Company’s lead drug, CF101, is being developed for the treatment of autoimmune inflammatory and ophthalmic diseases and the second drug candidate CF102 is developed for liver diseases, i.e., liver cancer and HCV.

Contacts:

Can-Fite BioPharma
Pnina Fishman, Ph.D., Chief Executive Officer
Tel: +972-3-9241114
Fax: +972-3-9249378
pnina@canfite.co.il
http://www.canfite.com/

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