Can-Fite BioPharma to commence Glaucoma Phase II clinical study in Israel

Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, announced on December 13 the initiation of the regulatory process for a Glaucoma Phase II clinical study in Israel. Leading Medical Centers in Israel will enroll 44 patients with Ocular Hypertension or Glaucoma for the first segment of the trial, who will be treated for 16 weeks with CF101 or placebo. The study will be expanded by up to an additional 88 patients upon successful conclusion of an interim analysis of the first segment. The study protocol was developed with the assistance of Dr. Paul Kaufman, a noted glaucoma researcher at the University of Wisconsin. The study will investigate the efficacy of CF101, as manifest by a decrease in intraocular pressure, as well as the safety of CF101 in this population.

The rationale for the conduct of this study is based on unexpected positive findings from the recently concluded Phase II study in Dry Eye, demonstrating a decrease in the intraocular 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 to 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 announced recently that it retained Plexus Ventures, a global pharmaceutical business development consultancy, to assist with the identification of a partner with the necessary expertise and the appropriate organization to support the clinical development and commercialization of CF101 in the United States, Europe and other markets. CF101 is already licensed out in Japan and South Korea.

Source CAN-FITE BIOPHARMA LTD