Full Press Release Details
Completes Phase II/III Trial for CF101 in Treatment of Psoriasis
expected to be released in Q1 2015
TIKVA, Israel, February 4, 2015 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a
pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that all patients
enrolled in its Phase II/III psoriasis trial for the Company's drug candidate CF101 have completed the study's 32
week treatment protocol. The trial has been completed and the final data is ready for analysis. The Company plans to publish top
line results by the end of March 2015. Interim results from this Phase II/III trial and final results from the prior Phase II
trial for CF101 in psoriasis were both positive.
a thorough analysis of the data over the coming weeks, we look forward to announcing top line results on the efficacy and safety
of CF101 in the treatment of moderate-to-severe plaque psoriasis. If these results are in line with the previously published favorable
interim data, then we believe CF101 could offer a much-needed treatment alternative to patients living with psoriasis,"
stated Can-Fite CEO Dr. Pnina Fishman.
psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and
have potential side effects. According to Global Data, the psoriasis treatment market was worth $3.6 billion in 2010 and is forecast
to grow to $6.7 billion by 2018.
Phase II/III double-blind, placebo-controlled study is designed to test the efficacy of CF101 in patients with moderate-to-severe
plaque psoriasis. Can-Fite enrolled 326 patients through 17 clinical centers in the U.S., Europe, and Israel. The first study
cohort was comprised of three arms with patients receiving: 1 mg of CF101; 2 mg of CF101; and placebo. All patients receiving
placebo were switched to either 1 mg or 2 mg of CF101 after 12 weeks. The primary efficacy endpoints are a statistically significant
improvement in standard measures used by dermatologists to assess psoriasis including the Psoriasis Area Sensitivity Index (PASI)
score and the secondary end points among others are the Physicians' Global Assessment (PGA) score as well as various safety parameters.
is a skin condition that affects 2% to 3% of the general population according to the National Psoriasis Foundation. The
disease is manifested by scaly plaques on the skin and in the severe form has a major effect on the physical and emotional well-being
of the patients. Topical agents are typically used for mild disease, phototherapy for moderate disease, and systemic agents for
severe disease. For moderate to severe cases, systemic biologic drugs, delivered via IV, have dominated the market. According
to the National Psoriasis Foundation, common side effects of biologics include respiratory infections, flu-like symptoms, and
injection site reactions while rare side effects include serious nervous system disorders, such as multiple sclerosis, seizures,
or inflammation of the nerves of the eyes, blood disorders, and certain types of cancer. We believe a significant need remains
for novel oral and safe drugs for patients who do not respond to existing therapies or for whom these therapies are unsuitable.
an A3 adenosine receptor agonist, is a novel, first in class, small molecule, orally bioavailable drug with a favorable therapeutic
index demonstrated in Phase II clinical studies. CF101 is currently developed for the treatment of autoimmune inflammatory diseases
including rheumatoid arthritis (completed Phase II) and psoriasis (Phase II/III).
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
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