Full Press Release Details
Completes Development of Commercial Biomarker Test to Predict Patients'
Response to Company Drugs
blood test to be used in clinical trials and as a companion diagnostic for Can-Fite's Drugs
TIKVA, Israel, March 18, 2015 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline
of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, announced
today it has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR).
The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested
and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite's drugs, which are
currently in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.
is present in high concentrations in inflammatory cells and cancer cells. Can-Fite's proprietary drugs target and bind to A3AR,
causing cancer and inflammatory cell apoptosis (programmed cell death). This creates a targeted anti-cancer and anti-inflammatory
effect, while leaving normal cells unharmed. Identifying patients with elevated A3AR levels would indicate which patients would
benefit most from Can-Fite's drugs, thereby offering personalized medicine.
completion of the development of our commercial A3AR biomarker test kit comes at a very important time since we plan to use the
test kit in our upcoming advanced clinical studies. We believe the test kit will create efficiencies in our trials in patient
enrollment and monitoring. As we progress into late-stage clinical trials for CF101 in auto-immune diseases, our A3AR biomarker
test kit is ready for wide-scale use to help doctors and their patients identify who will be most responsive to Can-Fite's
drugs. We believe these patients can significantly benefit from personalized medicine due to the high degree of clinical heterogeneity,"
stated Can-Fite CEO Dr. Pnina Fishman.
U.S. Patent and Trademark Office issued Can-Fite a patent for the utilization of A3AR as a biomarker to predict patient
response to its drug CF101 in autoimmune inflammatory indications. In December 2013, Can Fite reported favorable results from
its Phase IIb rheumatoid arthritis clinical trial for CF101, an A3AR agonist. Only patients with elevated baseline expression
levels of the biomarker A3AR were enrolled in the study. CF101 met all primary efficacy endpoints, showing statistically significant
superiority over placebo in reducing signs and symptoms of rheumatoid arthritis.
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE MKT: 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 CF101 is in Phase II/III trials for the treatment of psoriasis and the Company is preparing for a Phase III
CF101 trial for rheumatoid arthritis. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan
Drug Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers
including colon, prostate, and melanoma. The Company's CF602 has shown efficacy in the treatment of erectile dysfunction.
Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication.
These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information
please visit: www.can-fite.com
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. 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
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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, including, but not limited to, the factors summarized
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.