Can-Fite to Present at 2017 AASLD Liver Meeting Conference in Washington, D.C.
October 16 2017 - 7:00AM
Business Wire
- Data demonstrate Namodenoson’s liver
protective properties and support its use in the treatment of
non-alcoholic fatty liver disease (NAFLD) and non-alcoholic
steatohepatitis (NASH)
- Namodenoson being evaluated in Phase
II study as treatment for NAFLD/NASH, an indication for which no
FDA approved drug is available
- NASH estimated to be $35-40
billion addressable pharmaceutical market 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, today announced it will present two scientific posters at
the American Association for the Study of Liver Diseases (AASLD)
annual conference, The Liver Meeting® in Washington, D.C. on
October 20-24, 2017.
- Poster Title: Namodenoson (CF102)
Prevents Liver Fibrosis in the CCL4 Model
- Date & Time: Friday, October 20,
2017 at 8:00am ET
- Study Conducted by: Liver Unit,
Hadassah University Hospital and Can-Fite BioPharma
- Findings: In this study the
anti-inflammatory and anti-fibrogenic effects of Namodenoson are
demonstrated in a CCl4 mouse model manifested by a decrease in ALT,
NKT cell activity in the liver and signaling proteins including
α-SMA, PI3K and p-STAT-1. The data support the development of
Namodenoson as an attractive drug candidate to combat
NAFLD/NASH.
- Poster Title: The Anti-Fibrogenic and
Liver Protective Effects of Namodenoson (CF102) in a Non-Alcoholic
Steatohepatitis model
- Date & Time: Friday, October 20,
2017 at 8:00am ET
- Study Conducted by: Liver Unit,
Hadassah University Hospital and Can-Fite BioPharma
- Findings: Namodenoson’s
anti-inflammatory and anti-fibrogenic effect was demonstrated in a
STAM-NASH mouse model manifested in a marked reduction in NAS and
fibrosis area. Namodenoson treatment induced a decrease in CK-18
levels suggesting hepato-protective effect and at the same time
up-regulated adiponectin levels, reflecting anti-fibrogenic and
anti-inflammatory effects.
During the conference, Can-Fite will also conduct a meeting of
its NASH Clinical Advisory Board comprised of key opinion leaders
in the treatment of liver disease and NASH including Dr. Scott
Friedman, Dr. Arun Sanyal, and Dr. Rifaat Safadi.
“In addition to sharing our compelling findings about
Namodenoson at The Liver Meeting in Washington, D.C., we look
forward to meeting with our Clinical Advisory Board, as Namodenoson
enters a Phase II study in the treatment of NAFLD/NASH,” stated
Can-Fite CEO Dr. Pnina Fishman. “Through two experimental animal
models of NAFLD/NASH, the data show that treatment with Namodenoson
improved several parameters of liver function including
steatohepatitis and steato-fibrosis. We are committed to advancing
Namodenoson through its Phase II NAFLD/NASH study, as currently
there is no FDA approved drug for this condition which impacts a
growing number of people across the world.”
Namodenoson’s Phase II trial to determine the efficacy and
safety of the drug in the treatment of NAFLD/ NASH will enroll
approximately 60 patients with NAFLD, with or without NASH.
Patients will be enrolled in three arms, including two different
dosages of Namodenoson 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.
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
scheduled to enter a Phase III trial for rheumatoid arthritis in
2017 and a Phase III trial for psoriasis in early 2018. 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 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
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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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