Can-Fite’s Drug Namodenoson Approved for Compassionate Use Treatment of Advanced Liver Cancer Patients in Romania
August 23 2022 - 7:00AM
Business Wire
- Namodenoson induced a complete response with disappearance
of all metastases in a patient who will now continue the treatment
under a compassionate use program in Romania
- Can Fite’s Phase III pivotal study is open for patient
enrolment
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address inflammatory, cancer and liver
diseases, announced today its liver drug candidate Namodenoson has
been approved for compassionate use for the treatment of patients
with advanced liver cancer in Romania. Namodenoson was previously
approved for compassionate use in Israel, where advanced liver
cancer patients have been treated for several years.
In parallel, Can-Fite’s pivotal Phase III study in patients with
advanced liver cancer (hepatocellular carcinoma), is open for
patient enrolment and will recruit patients in Israel, the U.S.,
and five countries in Europe. This pivotal study received a ‘green
light’ to proceed from the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency (EMA), and if successfully
concluded, the Company will be in a position to submit the drug for
approval with each of the regulatory authorities. Namodenoson has
Orphan Drug Status with both the FDA and EMA and Fast Track Status
with the FDA. A registration plan has been submitted to and
accepted by the FDA.
“We are committed to providing Namodenoson, with an excellent
safety profile and strong efficacy in this patient population in
clinical trials to date, to fulfill an urgent unmet medical need.
The anti-cancer effect of Namodenoson together with its liver
protective properties make it unique among anti-cancer drugs for
this devastating disease,” stated Can-Fite CEO Dr. Pnina
Fishman.
The hepatocellular carcinoma (HCC) drug market is expected to
reach $3.8 billion in 2027 in the G8 countries according to
DelveInsight. The American Cancer Society estimates that in the
U.S., liver cancer incidence has tripled since 1980, with an
estimated 41,000 cases diagnosed and 31,000 deaths annually.
Incidence of liver cancer is much higher in other countries, with
more than 800,000 diagnoses and 700,000 deaths estimated globally
each year.
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 as a second line treatment for
advanced hepatocellular carcinoma in a pivotal Phase III trial. The
drug is currently in an ongoing Phase II trial 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, liver, and inflammatory disease. The
Company's lead drug candidate, Piclidenoson recently reported
topline results in a Phase III trial for psoriasis. Can-Fite's
liver drug, Namodenoson, is being evaluated in a Phase IIb trial
for the treatment of non-alcoholic steatohepatitis (NASH), and
enrollment is expected to commence in a Phase III trial for
hepatocellular carcinoma (HCC), the most common form of liver
cancer. 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, its product development efforts, business, financial
condition, results of operations, strategies or prospects. All
statements in this communication, other than those relating to
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Because forward-looking statements relate to matters that have not
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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
24, 2022 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.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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