Can-Fite Presented NASH Phase II Namodenoson Data at a Late Breaking Session of the American Association for the Study of Liv...
November 16 2020 - 7:00AM
Business Wire
Dr. Safadi, the study’s Principal
Investigator: “Namodenoson’s very impressive study data may result
in a promising drug for the treatment of NAFLD/NASH due to the
combination of good efficacy and favorable safety.”
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address inflammatory, cancer and liver
diseases, today announced that Dr. Rifaat Safadi, Principal
Investigator of the Company’s Phase II study of Namodenoson in the
treatment of NAFLD/NASH delivered a late-breaking oral
presentation at the AASLD conference, The Liver Meeting Digital
Experience™ 2020.
Titled “A Phase 2, Randomized, Double-Blind, Placebo-Controlled
Dose-Finding Study Of The Efficacy And Safety Of Namodenoson
(CF102), An A3 Adenosine Receptor (A3AR) Agonist, In Treating
Non-Alcoholic Fatty Liver Disease (NAFLD) And Non-Alcoholic
Steatohepatitis (NASH)” the oral presentation was given on Sunday,
November 15 by Dr. Safadi, Head of the Liver Unit, Gastroenterology
and Liver Diseases, Division of Medicine at Hadassah Medical
Center, Professor of Internal Medicine, Bowel, Liver Disease, and
Metabolic Syndrome at Hebrew University in Israel.
The double-blind, placebo-controlled, dose-finding efficacy and
safety study enrolled 60 patients with NAFLD with or without NASH.
Patients with evidence of an active inflammation were treated twice
daily with 12.5 mg (n=21) or 25 mg (n=19) of oral Namodenoson vs.
placebo (n=20). The patients were treated for 12 weeks and
followed-up until week 16. As a result of the study, 25 mg was
determined to be the optimal dose.
Data presented during the oral presentation included:
- Anti-Inflammatory effect – a significant decrease in the liver
enzymes ALT and AST and significant improvement in the positive
cytokine adiponectin was recorded in the Namodenoson 25 mg treated
group
- Reduced liver fat content - manifested by a significant
reduction in % of liver fat volume assessed by MRI-PDFF and a
decrease in the Controlled Attenuation Parameter (CAP – score ≥
331) measured by FibroScan in the Namodenoson 25 mg group
- Decrease in FIB-4 and FAST – non-invasive tests showed
anti-fibrosis effect in Namodenoson 25 mg group
- Decrease in body weight - a linear decrease in body weight was
recorded in the 25 mg and 12.5 mg Namodenoson groups with a better
effect in the higher dose
- Safety - Namodenoson continued to have a safe profile and was
very well tolerated with no drug emergent severe adverse effects
and no hepatotoxicity
“We were very pleased that the AASLD accepted our late breaking
abstract for an oral presentation, a prominent platform through
which we shared these important study results with the leading
scientists and health care professionals committed to preventing
and curing liver diseases. We thank Dr. Safadi for delivering the
presentation,” stated Can-Fite CEO Dr. Pnina Fishman.
Dr. Safadi added, “Namodenoson’s very impressive study data may
result in a promising drug for the treatment of NAFLD/NASH due to
the combination of good efficacy and favorable safety.”
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, liver, inflammatory disease and
COVID-19. The Company's lead drug candidate, Piclidenoson, is
currently in a Phase III trial for rheumatoid arthritis/psoriasis
and a Phase II study in the treatment of moderate COVID-19.
Can-Fite's liver drug, Namodenoson, is headed into a Phase III
trial for hepatocellular carcinoma (HCC), the most common form of
liver cancer, and successfully achieved its primary endpoint in a
Phase II trial 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. These drugs have an excellent safety
profile with experience in over 1,500 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: 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 impact of the COVID-19 pandemic; 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 BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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