Due to Patient Survival, Top Line Results of the Namodenoson Phase II Advanced Liver Cancer Trial Expected Q1/19
October 31 2018 - 07:00AM
Business Wire
- Namodenoson seeks to address a major
unmet need for Child Pugh B patients with advanced liver
cancer
- Namodenoson has received Fast Track
Status in the U.S. and Orphan Drug Designation in Europe and the
U.S.
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 provided an update on its Phase II clinical trial
of drug candidate Namodenoson (CF102) for the treatment of advanced
hepatocellular carcinoma (HCC) in patients with Child Pugh B whose
disease has progressed on sorafenib therapy. Due to patient
survival, top line efficacy results are expected during the first
quarter of 2019.
Enrollment of 78 patients was completed in August 2017 and the
trial continues treating subjects in a blinded fashion (either
Namodenoson 25 mg BID or matching placebo).
The statistical plan for this trial requires that the primary
efficacy analysis occurs when no more than 3 of the original 78
patients survive. At the outset of the trial, it was assumed that
patients with advanced HCC with Child-Pugh B had a relatively poor
prognosis, and that within approximately a year of enrollment of
the last subject, primary efficacy analysis could be conducted. In
order to maintain the statistical integrity of the trial as well as
adhere to the principles of Good Clinical Practice, the Company
estimates that it will un-blind the data during Q1/19.
Can-Fite's CEO, Dr. Pnina Fishman, commented, “This unexpectedly
prolonged longevity is unquestionably beneficial for the individual
patients, and gives us hope that Namodenoson may eventually prove
its value in this patient population.”
Can-Fite 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 HCC.
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, is in Phase
II trials for hepatocellular carcinoma (HCC), the most common form
of liver cancer, and 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
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Can-Fite’s expectations, beliefs or intentions regarding, among
other things, market risks and uncertainties, its product
development efforts, business, financial condition, results of
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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
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risks and other risk factors detailed in Can-Fite’s filings with
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publicly update these forward-looking statements, whether as a
result of new information, future events or otherwise.
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Can-Fite BioPharma, Ltd.Motti
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