Full Press Release Details
Advances Towards a Pivotal Phase III Clinical Trial in Psoriasis with
(CF101) Following Reaching Agreement with EMA
| - | Phase III clinical study designed to establish Piclidenoson is superior to placebo as primary endpoint and non-inferior to Otezla at week 32 as secondary endpoint | |
| - | Global psoriasis market estimated to reach $9 billion by 2018 |
TIKVA, Israel, November 1, 2016 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a
pipeline of proprietary small molecule drugs being developed to treat inflammatory and liver diseases, cancer and sexual dysfunction,
today announced that it has reached an agreement with the European Medicines Agency (EMA) on the final design of a global pivotal
Phase III trial for its lead drug candidate, Piclidenoson (CF101), in the treatment of psoriasis. Can-Fite intends to initiate
the Phase III trial in the second half of 2017.
planned Phase III trial is a randomized, double-blind, placebo- and active-controlled study that will investigate the efficacy
and safety of daily Piclidenoson administered orally as compared to placebo as its primary endpoint and as compared to apremilast
(Otezla ) as its secondary endpoint in approximately 400 patients with moderate-to-severe plaque psoriasis. Medication
is to be taken orally twice daily for 32 weeks in a double-blinded fashion. The primary end point will be the proportion of subjects
who achieve a Psoriasis Area and Severity Index (PASI) score response of 75% (PASI 75) vs. placebo at week 16. The secondary
endpoints will include non-inferiority to Otezla on week 32 and efficacy and safety data for CF101 through the
extension period of up to 48 weeks of treatment. Patients will be selected to the study based on over expression of the A3AR biomarker.
rationale of comparing Piclidenoson to Otezla , the recently registered oral drug marketed by Celgene, is based
on data from Can-Fite's prior Phase II/III study that showed at weeks 24 and 32, Piclidenoson's efficacy as measured
by PASI compares well to Otezla in its Phase III trial.
higher dosage of Piclidenoson together with the utilization of A3AR as a predictive biomarker for patient selection are expected
to be important in yielding a faster and efficacious response," stated Can-Fite CEO Dr. Pnina Fishman. "We believe
the agreed study design for this pivotal Phase III trial positions us well to demonstrate Piclidenoson's superior and faster
accumulation of efficacy. Given that Piclidenoson has exhibited excellent safety in prior clinical trials, we believe that this
presents an opportunity to treat patients who need to use drugs for a long time for this chronic disease."
global psoriasis market is estimated to reach $9 billion by 2018 (Visiongain), and Otezla sales are estimated
to be $2.35 billion by 2020 (DrugAnalyst).
Piclidenoson (CF101)
is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic
index demonstrated in Phase II clinical studies. Piclidenoson is currently under development for the treatment of autoimmune inflammatory
diseases including rheumatoid arthritis (completed Phase II) and psoriasis (completed 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 lead drug candidate, Piclidenoson, is scheduled to enter Phase III trials in 2016 for two indications, rheumatoid
arthritis and psoriasis. The rheumatoid arthritis Phase III protocol has recently been agreed with EMA. Can-Fite's liver cancer
drug CF102 is in Phase II trials for patients with liver cancer and is slated to enter Phase II for the treatment of non-alcoholic
steatohepatitis (NASH). CF102 has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a
second line treatment for hepatocellular carcinoma 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. CF602, the Company's third drug candidate, has
shown efficacy in the treatment of erectile dysfunction in preclinical studies and is being prepared for an IND submission to
the FDA and a Phase I trial. 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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