Dec 15 2009
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