PETACH TIKVA, Israel,
Oct. 13, 2016 /PRNewswire/
-- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a
biotechnology company with a pipeline of proprietary small molecule
drugs being developed to treat inflammatory and liver diseases,
cancer, and sexual dysfunction, today announced it has submitted
the clinical trial protocol for its Phase II study of CF102 in the
treatment of non-alcoholic fatty liver disease (NAFLD), the
precursor to non-alcoholic steatohepatitis (NASH), to a leading
Institutional Review Board (IRB) in Israel. Top medical centers in Israel, including Hadassah Medical Center and
Rabin Medical Center are expected to participate in the planned
study by enrolling and treating patients.
"We are eager to commence our Phase II study in NAFLD/NASH, an
indication for which there is no U.S. FDA approved drug. We view
the submission of our clinical trial protocol as a major step
forward," stated Can-Fite CEO Dr. Pnina
Fishman.
Based on the protocol that was submitted, Can-Fite's Phase II
study, designed by world renowned Key Opinion Leaders in the field
of liver diseases, will be a multicenter, randomized,
double-blinded, placebo-controlled, dose-finding study of the
efficacy and safety of CF102 in the treatment of NAFLD/NASH. The
study will enroll approximately 60 patients with NAFLD, with or
without NASH, and will have three arms, including two different
dosages of CF102 and a placebo, given via oral tablets twice daily.
The study's primary endpoints will be percent change from baseline
in liver triglyceride (fat) concentration measured by nuclear
magnetic resonance spectroscopy (NMRS) and safety. Secondary
endpoints to be evaluated are the effects of CF102 on metabolic
abnormalities in subjects with NAFLD, including body weight, waist
circumference, serum triglyceride and high-density lipoprotein
cholesterol levels, and serum liver transaminase. In addition, an
assessment of the pharmacokinetics (PK) of CF102 and the A3
adenosine receptor (A3AR) biomarker will be evaluated prior to
treatment and its correlation to patients' response to the drug
will be analyzed upon study conclusion. Furthermore, the
exploratory objective of this study is to evaluate the effects of
CF102 on relevant biomarkers, such as adiponectin, leptin,
C-reactive protein (CRP), and liver stiffness as determined by
Fibroscan. The trial design is based on preclinical studies showing
CF102's efficacy in reducing liver fat in NASH models as compared
to placebo, improving liver function, and regenerating liver
cells.
Deutsche Bank estimates the addressable pharmaceutical market
for NASH will reach $35-40 billion in
size by 2025.
About NAFLD/NASH
NAFLD is characterized by excess fat accumulation in the form of
triglycerides (steatosis) in the liver. According to a recent study
published in Hepatology, an estimated 25% 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.
About CF102
CF102 is a small orally bioavailable drug that binds with high
affinity and selectivity to the A3 adenosine receptor (A3AR). 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. In Can-Fite's pre-clinical
and clinical studies, CF102 has demonstrated a robust anti-tumor
effect via deregulation of the Wnt signaling pathway, resulting in
apoptosis of liver cancer cells. Based on preclinical data showing
CF102 has strong liver protective properties, Can-Fite intends to
initiate a Phase II study in NASH. Can-Fite has received Orphan
Drug Designation for CF102 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 MKT: 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
scheduled to enter Phase III trials in 2016 for two indications,
rheumatoid arthritis and psoriasis. The rheumatoid arthritis Phase
III protocol has recently been agreed with the European Medicines
Agency. Can-Fite's liver cancer drug CF102 is in Phase II trials
for patients with liver cancer and is slated to enter Phase II for
the treatment of non-alcoholic steatohepatitis (NASH). CF102 has
been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second
line treatment for hepatocellular carcinoma by the U.S. Food and
Drug Administration. CF102 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 is being prepared for an IND submission to the FDA and
a Phase I trial. 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, 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, including, but not limited to, the
factors summarized 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.
Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
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SOURCE Can-Fite BioPharma Ltd.