Can-Fite Enrolls First Patient in Phase II NAFLD/NASH Study with Namodenoson
November 27 2017 - 7:00AM
Business Wire
- Data show Namodenoson’s efficacy in
reducing liver fat and fibrosis in NASH models
- No FDA approved drug yet for NASH
indication, an unmet medical need estimated to reach $35-40 billion
by 2025
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address cancer, liver and inflammatory
diseases, announced today that the first patient, of the planned 60
patients, has been enrolled in a Phase II trial of its drug
candidate Namodenoson (CF102) in the treatment of non-alcoholic
fatty liver disease (NAFLD) and non-alcoholic steatohepatitis
(NASH). There is currently no U.S. FDA approved drug for the
treatment of NASH, which is an addressable pharmaceutical market
estimated to reach $35-40 billion by 2025.
Can-Fite’s 12-week study is being led by Key Opinion Leaders in
the area of NASH and liver disease. Clinical trial sites are some
of the most prestigious medical institutions in the world including
Hadassah Medical Center and Rabin Medical Center.
“By enrolling the first patient in this study, we move forward
to evaluate the potential of Namodenoson to help the growing number
of people diagnosed with NASH and its precursor, NAFLD,” stated
Can-Fite CEO Dr. Pnina Fishman. “We believe that the liver
protective effect of Namodenoson in NASH models, together with the
drug’s robust safety profile, make it a promising drug candidate
for this indication. There is a pressing and unmet need in the
medical community for a variety of safe and effective drugs to
treat fatty liver disease. We believe our 12-week Phase II study,
designed by the world’s leading experts in NAFLD and NASH, can
efficiently inform the potential of Namodenoson in this
indication.”
The Phase II multicenter, randomized, double-blinded,
placebo-controlled, dose-finding study of the efficacy and safety
of Namodenoson in the treatment of NAFLD/NASH is enrolling
approximately 60 patients with NAFLD, with or without NASH.
Patients are being enrolled in three arms, including two different
dosages of Namodenoson and a placebo, given via oral tablets twice
daily. The study's primary endpoints are percent change from
baseline in liver triglyceride (fat) concentration and safety.
The Phase II trial design is based on preclinical studies
showing Namodenoson's efficacy in reducing liver fat, ballooning,
and fibrosis in NASH models. Can-Fite’s estimated cost for the
Phase II trial is under $1 million.
About NAFLD/NASH
NAFLD is characterized by excess fat accumulation in the form of
triglycerides (steatosis) in the liver. According to a study
published in Hepatology, an estimated 17%-33% of the population in
the U.S. has NAFLD, with a higher prevalence in people with type II
diabetes. Incidence is increasing based on rising obesity rates.
NAFLD includes a range of liver diseases, with NASH being the more
advanced form, manifesting as hepatic injury and inflammation.
According to the NIH, the incidence of NASH in the U.S. is believed
to affect 2-5% of the population. The spectrum of NAFLDs resembles
alcoholic liver disease; however, they occur in people who drink
little or no alcohol. If untreated, NASH can lead to cirrhosis and
liver cancer. By 2025, the addressable pharmaceutical market for
NASH is estimated to reach $35-40 billion.
About Namodenoson (CF102)
Namodenoson is a small orally bioavailable drug that binds with
high affinity and selectivity to the A3 adenosine receptor (A3AR).
Namodenoson is being evaluated in Phase II trials for two
indications, as a second line treatment for hepatocellular
carcinoma, and as a treatment for non-alcoholic fatty liver disease
(NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly
expressed in diseased cells whereas low expression is found in
normal cells. This differential effect accounts for the excellent
safety profile of the drug. Can-Fite has received Orphan Drug
Designation for Namodenoson in Europe and the U.S., as well as Fast
Track Status in the U.S. as a second line treatment for
hepatocellular carcinoma.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an
advanced clinical stage drug development Company with a platform
technology that is designed to address multi-billion dollar markets
in the treatment of cancer, inflammatory disease and sexual
dysfunction. The Company's lead drug candidate, Piclidenoson, is
currently in a Phase III trial for rheumatoid arthritis and is
expected to enter a Phase III trial for psoriasis in early 2018.
Can-Fite's liver cancer drug, Namodenoson, is in Phase II trials
for hepatocellular carcinoma (HCC), the most common form of liver
cancer, and for the treatment of non-alcoholic steatohepatitis
(NASH). Namodenoson has been granted Orphan Drug Designation in the
U.S. and Europe and Fast Track Designation as a second line
treatment for HCC by the U.S. Food and Drug Administration.
Namodenoson has also shown proof of concept to potentially treat
other cancers including colon, prostate, and melanoma. CF602, the
Company's third drug candidate, has shown efficacy in the treatment
of erectile dysfunction in preclinical studies and the Company is
investigating additional compounds, targeting A3AR, for the
treatment of sexual dysfunction. These drugs have an excellent
safety profile with experience in over 1,000 patients in clinical
studies to date. For more information please visit:
www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about
Can-Fite's expectations, beliefs or intentions regarding, among
other things, market risks and uncertainties, its product
development efforts, business, financial condition, results of
operations, strategies or prospects. In addition, from time to
time, Can-Fite or its representatives have made or may make
forward-looking statements, orally or in writing. Forward-looking
statements can be identified by the use of forward-looking words
such as "believe," "expect," "intend," "plan," "may," "should" or
"anticipate" or their negatives or other variations of these words
or other comparable words or by the fact that these statements do
not relate strictly to historical or current matters. These
forward-looking statements may be included in, but are not limited
to, various filings made by Can-Fite with the U.S. Securities and
Exchange Commission, press releases or oral statements made by or
with the approval of one of Can-Fite's authorized executive
officers. Forward-looking statements relate to anticipated or
expected events, activities, trends or results as of the date they
are made. Because forward-looking statements relate to matters that
have not yet occurred, these statements are inherently subject to
risks and uncertainties that could cause Can-Fite's actual results
to differ materially from any future results expressed or implied
by the forward-looking statements. Many factors could cause
Can-Fite's actual activities or results to differ materially from
the activities and results anticipated in such forward-looking
statements. Factors that could cause our actual results to differ
materially from those expressed or implied in such forward-looking
statements include, but are not limited to: the initiation, timing,
progress and results of our preclinical studies, clinical trials
and other product candidate development efforts; our ability to
advance our product candidates into clinical trials or to
successfully complete our preclinical studies or clinical trials;
our receipt of regulatory approvals for our product candidates, and
the timing of other regulatory filings and approvals; the clinical
development, commercialization and market acceptance of our product
candidates; our ability to establish and maintain corporate
collaborations; the implementation of our business model and
strategic plans for our business and product candidates; the scope
of protection we are able to establish and maintain for
intellectual property rights covering our product candidates and
our ability to operate our business without infringing the
intellectual property rights of others; estimates of our expenses,
future revenues, capital requirements and our needs for additional
financing; competitive companies, technologies and our industry;
statements as to the impact of the political and security situation
in Israel on our business; and risks and other risk factors
detailed in Can-Fite's filings with the SEC and in its periodic
filings with the TASE. In addition, Can-Fite operates in an
industry sector where securities values are highly volatile and may
be influenced by economic and other factors beyond its control.
Can-Fite does not undertake any obligation to publicly update these
forward-looking statements, whether as a result of new information,
future events or otherwise.
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Can-Fite BioPharmaMotti Farbstein,
+972-3-9241114info@canfite.com
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