Full Press Release Details
Can-Fite Announces Phase II Advanced Liver Cancer Top-Line
Results for its Orphan/Fast Track Drug Namodenoson
Conference call with management scheduled for today, Tuesday
March 26 at 8.30 a.m. Eastern time
PETACH TIKVA, Israel, March 26, 2019 --
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs
that address cancer, liver and inflammatory diseases, announced today that the Phase II advanced liver cancer study did not achieve
its primary end point of overall survival in the whole population (n=78). At the same time, superiority in overall survival was
found in the largest study subpopulation of CPB7 (n=56) and in secondary end points in the whole population, including objective
response measured by CT or MRI. These data strongly support the progression into Phase III.
Advanced liver cancer in patients with
underlying cirrhosis is categorized into three subclasses based on the severity of cirrhosis, starting with Child Pugh A (CPA),
mostly treated with Nexavar and progressing to Child Pugh B (CPB) and Child Pugh C (CPC), for which
there are no drugs on market with proven efficacy.
In the study, the Company enrolled only
patients with CPB stage liver cancer with CBP stage patients being further divided into three categories of increasing severity,
namely CPB7, CPB8, and CPB9. These patients already failed first line Nexavar and were treated with Namodenoson (25mg), or placebo,
as a second line treatment, twice daily, using a 2:1 randomization. The primary endpoint of the study was defined as the length
of time the patients lived after receiving treatment or median overall survival (OS). Secondary endpoints included safety,
the length of time tumors did not grow after treatment, or progression free survival (PFS), the percent of patients whose
tumors partially shrank after treatment, or partial response (PR), and the percent of patients who were PR or stable, or
disease control rate (DCR).
Findings from the study include the following:
Dr. Llovet, a Founder and 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 in the BCLC Group, Liver Unit, IDIBAPS-Hospital Cl nic, University of Barcelona, stated, "The global
incidence of liver cancer continues to increase and has more than tripled in the United States over the last three decades, and
currently there are no recommended systemic treatment options for patients with advanced HCC and severe liver dysfunction (Child
Pugh B)." Dr. Llovet added, "Considering that patients with advanced HCC and severe liver dysfunction do not have any
accepted standard of care, the current data from this Phase II trial suggest a signal of efficacy that supports continuing the
development of Namodenoson with a Phase III study in this population. I will be happy to help with the design of the Phase III
and serve as the principal investigator of the trial."
Dr. Salomon M Stemmer, Institute of Oncology,
Davidoff Center, Rabin Medical Center, Petah Tikva/Sackler Faculty of Medicine, Tel Aviv University, Israel and the study principal
investigator, added, "Given the evidence of Namodenoson's clinical benefit, I plan on offering it to selected HCC CPB
patients in the compassionate use setting."
"We are encouraged by the advantage
shown by Namodenoson in the CPB7 HCC population, a group for which there are no drugs with proven effectiveness," stated
Pnina Fishman, Chief Executive Officer of Can-Fite. "Since Namodenoson has a favorable safety profile and shows no evidence
of hepatotoxicity, it may possess a unique therapeutic index in this high-need population. Given that Namodenoson has been granted
Fast Track status by the FDA, we look forward to engaging regulatory authorities in a dialog at the earliest opportunity."
An abstract for the late-breaking session
has been submitted to The American Society of Clinical Oncology (ASCO) annual meeting, to take place May, 2019 in Chicago, IL,
The Company's management will host
a conference call today at 8:30 a.m. Eastern time to discuss the results of the Phase II advanced liver cancer trial. To participate
in the conference call, please dial 877-705-6003 (domestic) or 201-493-6725 (international) or 1 809 406 247 in Israel, five minutes
prior to the start of the call and provide the Conference ID: 13689112. Investors may also listen via webcast at: http://public.viavid.com/index.php?id=133770.
A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 90
days following the call.
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.
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