Can-Fite Concludes Successful Meeting with European Medicines Agency (EMA) Regarding Phase III Trial & Registration Plan for ...
June 04 2020 - 7:14AM
Business Wire
Following meetings with both the U.S. FDA
and EMA, Can-Fite is ready to submit its protocol and conduct one
pivotal trial for registration in both markets
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 it has successfully concluded a meeting
with the Scientific Advice Working Party (SAWP) of the European
Medicines Agency (EMA) regarding Phase III development of its drug
candidate Namodenoson in the treatment of hepatocellular carcinoma
(HCC), the most common form of liver cancer.
Namodenoson is Can-Fite’s adenosine A3 receptor (A3AR) agonist
which has recently been shown to prolong median overall survival
(OS) in a selected patient population with HCC in a Phase II
clinical trial. Can-Fite sought scientific advice from the EMA to
complement previous input from the U.S. Food and Drug
Administration (FDA) in its recent End-of-Phase II meeting
regarding plans for a Phase III registration trial of Namodenoson
in patients with HCC and Child Pugh Class B7 (CPB7) cirrhosis.
Having completed its meeting with the SAWP, Can-Fite now has
sufficient regulatory input to conduct a registration trial in
accordance with the requirements of both the U.S. and the European
Union.
The planned trial, a randomized, double blind, placebo
controlled trial, will enroll approximately 450 patients with HCC
and underlying CPB7 cirrhosis at multiple centers worldwide.
Patients will be randomized to oral treatment with either
Namodenoson 25 mg or matching placebo given twice daily. The
primary efficacy endpoint of the trial is overall survival (OS),
based on the favorable OS response seen in the Phase II trial in
patients with HCC and CPB7 cirrhosis. Other oncology trial efficacy
outcomes, such as tumor radiographic response rates and median
progression-free survival, as well as standard safety parameters,
will be assessed.
“We appreciate the EMA’s advice which, combined with the input
we received last October from the U.S. FDA along with
recommendations from our academic key opinion leaders, gives us
excellent guidance for conducting a successful Phase III clinical
and registration program,” stated Can-Fite CEO Dr. Pnina
Fishman.
According to the American Cancer Society, liver cancer accounts
for more than 700,000 deaths globally each year. HCC is commonly
aggressive with poor survival rates. As new drugs that effectively
and safely treat HCC are developed and approved, the market for HCC
treatments is estimated by Delveinsight to reach $3.8 billion by
2027 for the G8 countries.
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
hepatocellular carcinoma, with a recently completed Phase II trial
and planned Phase III trial in this indication. The drug recently
concluded a Phase II trial which successfully achieved efficacy and
safety endpoints in the 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 COVID-19. The
Company's lead drug candidate, Piclidenoson, is currently in Phase
III trials for rheumatoid arthritis and psoriasis. Piclidenoson has
been approved for a pilot clinical trial in Israel to treat
COVID-19 infected patients with moderate-to-severe symptoms.
Can-Fite's liver drug, Namodenoson, is heading 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 recent outbreak of coronavirus;
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200604005357/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
Can Fite BioPharma (AMEX:CANF)
Historical Stock Chart
From Aug 2024 to Sep 2024
Can Fite BioPharma (AMEX:CANF)
Historical Stock Chart
From Sep 2023 to Sep 2024