Can-Fite Reports on New Pre-Clinical Developments with Its NASH Drug Namodenoson
11 June 2018 - 9:00PM
Business Wire
- Robust anti-NASH effects when drug
is administered orally
- Data support the selection of the
primary endpoint for the ongoing Phase II study
- Enrollment for the Phase II study is
expected to be completed end of 2018; data release expected in
H1/2019
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address inflammatory and liver diseases, today
provided an update on new pre-clinical data supporting the
selection of the primary endpoint for the current ongoing Phase II
study in NAFLD/NASH patients.
The data came out of a recently signed collaborative research
agreement with Hadassah Medical School, directed by Rifaat Safadi,
M.D., Head of the Liver Unit, Gastroenterology and Liver Diseases,
Division of Medicine at Hadassah Medical Center and Professor of
Internal Medicine, Bowel, Liver Disease, and Metabolic Syndrome at
Hebrew University in Israel.
In an experimental non-alcoholic steatohepatitis (NASH) CCL4
model, Namodenoson had a highly significant effect against
inflammation, necrosis, fibrosis and biliary hyperplasia, while
treating the animals orally with the drug. More specifically, the
liver enzymes ALT and AST were dramatically reduced and reversed to
normal values upon treatment of the NASH bearing animals with
Namodenoson. Further studies on the molecular mechanism of action
are ongoing.
Dr. Safadi commented: “These data are very encouraging in light
of the fact that the drug has been administered orally and induced
robust effect on liver enzyme levels.” Dr. Safadi added that “ALT
is the primary end point of the current ongoing Phase II study
based on former pre-clinical data and the current results support
and strengthen our belief that we will be able to see similar data
in the patients.”
The detailed data has been submitted for presentation at the
American Association for the Study of Liver Diseases (AASLD) annual
conference, The Liver Meeting® in San Francisco, Moscone Center
California, USA to be held on November 9-13, 2018.
The Phase II study is currently ongoing in Israel and aimed at
the enrollment of 60 patients who suffer from NAFLD/NASH with
evidence of active inflammation. The patients are treated twice
daily with 12.5 or 25 mg of oral Namodenoson vs. placebo for 12
weeks. The primary end point of the Phase II study is the
anti-inflammatory effect of the drug, as determined by ALT blood
levels, and the secondary end points include percentage of liver
fat, as measured by MRI-PDFF (proton density fat fraction). The
Company anticipates the completion of patient enrollment toward the
end of 2018 and data release in the first half of 2019.
Recent safety data showed that Namodenoson has a favorable
profile and lack of hepatotoxicity in patients.
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.
About Namodenoson
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.
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 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
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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: our history of losses
and needs for additional capital to fund our operations and our
inability to obtain additional capital on acceptable terms, or at
all; uncertainties of cash flows and inability to meet working
capital needs; 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 strategic partnerships and other 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; 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(800)
716-4880IR@canfite.co.ilcanf@irthcommunications.com
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