PETACH TIKVA, Israel,
Feb. 28, 2017 /PRNewswire/
-- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address cancer, liver and inflammatory
diseases, today announced new data that show its liver disease drug
candidate Namodenoson (CF102) prevented liver (hepatic) fibrosis
progression in preclinical studies.
"These latest study results add to the growing body of data that
demonstrate Namodenoson's potential efficacy in combating
non-alcoholic fatty liver disease (NAFLD), the precursor to
non-alcoholic steatohepatitis (NASH), indications for which there
is currently no FDA approved drug. We are advancing Namodenoson
into a Phase II trial in NAFLD and expect to commence patient
enrollment in the coming months through leading medical
institutions in Israel," stated
Can-Fite CEO Dr. Pnina
Fishman.
Liver fibrosis is the excessive accumulation of scar tissue
resulting from ongoing inflammation. It can result in diminished
blood flow throughout the liver and is associated with NAFLD.
Recent preclinical studies in a mouse model of liver fibrosis
demonstrated the anti-fibrotic effects of Namodenoson. The
Namodenoson treated group exhibited normal liver under macroscopic
view, no accumulation of fluid (ascites), a low fibrosis profile,
and lower serum levels of transaminases as compared to the control
group. In addition, liver protein extracts and mRNA for the alpha
smooth muscle actin showed a significant anti-fibrotic effect in
the Namodenoson treated group as compared to the control group.
These studies were conducted by a third party under the
supervision of Prof. Rifaat Safadi
M.D., a Key Opinion Leader in the field of liver diseases,
and Director of Liver Unit, Institute of Gastroenterology and Liver
Diseases, Hadassah University Hospital, Ein
Kerem.
Prof. Safadi commented, "Lowering liver fat content and
fibrosis are the main unmet needs in NASH. Today there is a huge
market need for drugs that fight the worldwide NASH epidemic."
"Namodenoson is uniquely compelling for its potential to treat
NAFLD and NASH because its safety profile has already been
de-risked, increasing the likelihood it can advance through late
stage trials and into clinical use for this large and unmet need,"
Dr. Safadi added. "In general, there is significant development
risk for new potential drugs in development due to safety risks
including drug induced liver injury (DILI), drug-to-drug
interactions (DDI), and metabolites in safety testing (MIST).
Namodenoson, however, has demonstrated a good safety profile and is
low or negative for DILI, DDI and MIST."
"In addition, Namodenoson recognizes the difference between
diseased and normal cells, and targets only the diseased cells
through the specific A3 adenosine receptor. This precision
targeting is designed to lead to higher efficacy and safety by
leaving healthy cells unaffected. We are all looking for drugs with
this profile to treat NASH," concluded Dr. Safadi.
By 2025, the addressable pharmaceutical market for NASH is
estimated to reach $35-40
billion.
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 Namodenoson (CF102)
Namodenoson 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, Namodenoson 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 Namodenoson has strong liver protective properties,
Can-Fite intends to initiate a Phase II study in NASH. 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 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 2017 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 Namodenoson 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).
Namodenoson 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. 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 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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/new-preclinical-data-show-can-fites-namodenoson-cf102-prevents-progression-of-liver-fibrosis-300414630.html
SOURCE Can-Fite BioPharma Ltd.