Can-Fite Broadens its Strong Intellectual Property (IP) for NASH: Received Patent Allowance in Canada
28 Febrero 2024 - 6:00AM
Business Wire
Patent has already been issued in other major
markets including the U.S., EU, Japan and China
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address oncological and inflammatory diseases,
today announced it received a Notice of Allowance from the Canadian
Intellectual Property Office for its patent application titled “An
A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat
Accumulation”. This invention addresses the use of Namodenoson for
the reduction of liver fat in patients with NASH a clinical
indication that is being developed by Can-Fite. In a successfully
concluded Phase IIa study, Namodenoson, one of the Company’s two
drugs in advanced clinical development, reduced liver fat content,
showed anti-inflammatory effects manifested by a significant
decrease in the liver enzymes ALT & AST, and decreased body
weight in patients with NASH. A Company-sponsored study for
Namodenoson for this indication is currently enrolling patients for
a Phase IIb study which will include 140 patients, in whom liver
pathology is the primary endpoint.
Can-Fite’s Namodenoson, is currently out-licensed for the
treatment of NASH to the Swiss company Ewopharma for territories in
Eastern Europe, to CMS China for the territories of China, HK and
Macau, and to the South Korean company CKD for the territory of
South Korea. The Company also has a distribution agreement in
Canada for its anti-inflammatory drug, Piclidenoson, for the
treatment of psoriasis.
“This additional patent in Canada for fatty liver disease adds
to our growing IP estate for this high-value indication of the
Namodenoson drug candidate. Our strong and broad IP, together with
the positive data from the Phase IIa and the drug safety, position
it as a promising candidate for the treatment of this liver
disease,” stated Dr. Ilan Cohn, Can-Fite founder, a recognized
business development expert in the medical arena, and also a
leading Israeli patent attorney and Partner & co-Founder of
Cohn, de Vries, Stadler & Co, Patent and Trademark
Attorneys.
The NASH market is expected to reach $24 billion by 2028.
According to the American Liver Foundation, between 30-40% of
adults in the U.S. have non-alcoholic fatty liver disease, one of
the most common causes of liver disease in the U.S. Non-alcoholic
steatohepatitis affects up to 5% of Americans, or up to 16 million
people and is expected to be most frequent reason for liver
transplants in the U.S. by 2030.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with
high affinity and selectivity to the A3 adenosine receptor (A3AR).
Namodenoson is currently being evaluated in a pivotal Phase III
trial for advanced liver cancer, a Phase IIb trial for the
treatment of steatotic liver disease (SLD), and the Company is
planning a Phase IIa study in pancreatic cancer. A3AR is highly
expressed in diseased cells whereas low expression is found in
normal cells. This differential expression may be one of the
important factors that accounts for the excellent safety profile of
the drug.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an
advanced clinical stage drug development Company with a platform
technology that addresses multi-billion dollar markets in the
treatment of cancer, liver, and inflammatory disease. One of the
two Company's lead drug candidates, Piclidenoson recently reported
positive topline results in a Phase III trial for psoriasis. A
pivotal Phase III for this drug is expected to commence soon.
Can-Fite's other lead drug for treating cancer and liver diseases,
Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of steatotic liver disease (SLD), a Phase III pivotal
trial for hepatocellular carcinoma (HCC), and the Company is
planning a Phase IIa study in pancreatic cancer. Namodenoson has
been granted Orphan Drug Designation in the U.S. and Europe for its
HCC indication 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. Piclidenoson and Namodenoson have an
excellent safety profile with experience in over 1,600 patients in
clinical studies to date. For more information please visit:
www.canfite.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. All
statements in this communication, other than those relating to
historical facts, are “forward looking statements”. 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.
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 known and
unknown risks, uncertainties and other factors that may cause
Can-Fite’s actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. Important factors that could cause actual results,
performance or achievements to differ materially from those
anticipated in these forward-looking statements include, among
other things, 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; risks
related to the COVID-19 pandemic and the Russian invasion of
Ukraine; risks related to not satisfying the continued listing
requirements of NYSE American; and statements as to the impact of
the political and security situation in Israel on our business.
More information on these risks, uncertainties and other factors is
included from time to time in the “Risk Factors” section of
Can-Fite’s Annual Report on Form 20-F filed with the SEC on March
30, 2023 and other public reports filed with the SEC and in its
periodic filings with the TASE. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Can-Fite
undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240228950836/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
Can Fite BioPharma (AMEX:CANF)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Can Fite BioPharma (AMEX:CANF)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024