Can-Fite Announces Preparation for End-of-Phase II Meeting with FDA to Initiate the Phase III Liver Cancer Study for Namodeno...
May 06 2019 - 7:00AM
Business Wire
Fast Track and Orphan Drug Status; No
treatment currently exists for advanced liver cancer patients in
whom the current standard of care does not work
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biotechnology company with a pipeline of proprietary small molecule
drugs that address cancer, liver and inflammatory diseases,
announced today it is conducting preparatory work for a planned
pivotal Phase III study of its drug candidate Namodenoson in the
treatment of advanced liver cancer in patients as a first line and
second line treatment. The Company recently announced results from
its Phase II study of Namodenoson in the treatment of advanced
liver cancer. Namodenoson was found to increase overall survival in
hepatocellular carcinoma (HCC) patients with Child Pugh B7, the
largest subpopulation of the study, as compared to placebo, even
though the trial did not meet its primary endpoint.
An end of Phase II meeting with the U.S. Food and Drug
Administration to review study data and to present the design of
the Phase III clinical trial is expected soon. The FDA has granted
Namodenoson both Orphan Drug and Fast Track status providing a
pathway for accelerated approval based on unmet need in the
treatment of advanced liver cancer. Fast Track designation offers
advantages including more frequent meetings with the FDA and
rolling review, which provides the opportunity to submit parts of
its New Drug Application (NDA) for review prior to completing the
entire application for commercialization. Orphan Drug designation
includes 7-year market exclusivity following marketing approval,
FDA assistance during the drug development process, and exemption
of application fees.
Key Opinion Leader in liver cancer, Dr. Josep Llovet is slated
to be the Principal Investigator of the planned Phase III trial and
is currently working closely with Can-Fite on the study’s protocol
and design. Dr. Llovet is the Director of the Liver Cancer Program
and Full Professor of Medicine at the Mount Sinai School of
Medicine, New York University, and Professor of Research-ICREA
Liver Unit, IDIBAPS-Hospital Clinic, University of Barcelona.
Dr. Llovet commented, "Today, patients with advanced liver
cancer and severe liver dysfunction do not have any accepted
standard of care that is effective. Based on Namodenoson’s signal
of efficacy in the recently completed Phase II trial, a Phase III
study in the population of patients with HCC Child Pugh B7 is
warranted and I am pleased to help with the design of the Phase III
study and to serve as the Principal Investigator of the trial.”
Can-Fite has engaged the services of a clinical research
organization (CRO), the Weinberg Group, based in Washington DC to
help with the preparation of all materials for the FDA meeting.
“We look forward to our upcoming meeting with the FDA regarding
our Phase III study design. We are hopeful that based on efficacy
data in the largest subgroup of the patient population from our
Phase II study, we can move forward into a pivotal Phase III trial
for marketing approval with the guidance of the FDA,” stated
Can-Fite CEO Pnina Fishman.”
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 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.
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
currently in Phase III trials for rheumatoid arthritis and
psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently
completed a Phase II trial for hepatocellular carcinoma (HCC), the
most common form of liver cancer, and is 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 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
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 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 BioPharmaMotti
Farbsteininfo@canfite.com+972-3-9241114
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