Full Press Release Details
Submits Phase III Protocol to IRB for CF101 in the Treatment of Rheumatoid Arthritis
| Pivotal Phase III trial to enroll approximately 456 patients for robust statistically significant data | ||
| Phase III protocol submission follows Can-Fite's successful meeting with the Medical Products Agency (MPA) in Sweden | ||
| CF101 to serve rheumatoid arthritis market forecast to reach $38.5 B by 2017 |
TIKVA, Israel, January 5, 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 diseases, cancer and sexual dysfunction, announced
today an important milestone towards beginning the pivotal Phase III trial of its lead drug candidate CF101 in the treatment of
rheumatoid arthritis. Can-Fite has submitted its Phase III clinical study protocol to the Institutional Review Board (IRB) of
Barzilai Medical Center in Israel and will file similar submissions in several European countries, Canada and the U.S.
Phase III protocol submission in Israel follows a successful meeting that Can-Fite concluded on December 8, 2015 with the Medical
Products Agency (MPA) in Sweden regarding the European registration of CF101 in the treatment of rheumatoid arthritis. During
the meeting, Can-Fite presented data from the Company's successful Phase II trial in rheumatoid arthritis and the CF101
rheumatoid arthritis clinical registration strategy was discussed. Agreement was reached on MPA's expectations for the registration
plan and the Phase III patient population, dosing, study endpoints, treatment duration and placebo management.
Company plans to conduct a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that will
investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis
treated with conventional drugs. The study will have three arms, a 1 mg CF101 dose, a 2 mg CF101 dose and placebo, given orally
twice daily in the form of tablets. Approximately 456 patients are expected to be enrolled in the study, where sample size has
been estimated to demonstrate definitive efficacy of CF101 based on the ACR20 response. The A3 adenosine receptor biomarker will
be evaluated prior to treatment and its correlation to patients' response to the drug will be analyzed upon study conclusion.
are now concluding the preparatory work to file our Phase III protocol with the European Medicines Agency (EMA) in the first quarter
of 2016," stated Can-Fite CEO Dr. Pnina Fishman. "Our newly strengthened cash position following our recent fund raises
totaling approximately $14 million is intended to support this pivotal trial."
arthritis is a chronic, systematic, autoimmune inflammatory disease that manifests as joint pain, stiffness, and swelling.
According to Visiongain, the global rheumatoid arthritis market is forecasted to reach $38.5 billion by 2017.
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. CF101 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 CF101 drug candidate is currently under advanced clinical development, preparing to enter Phase III trials
for two indications, rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug CF102 is in Phase II trials for patients
with advanced liver cancer and is being investigated as a potential treatment for non-alcoholic steatohepatitis (NASH). CF102
has been granted Fast Track Designation as a second line treatment for hepatocellular carcinoma (HCC) by the U.S. FDA. It has
also received Orphan Drug Designation for the treatment of HCC in the U.S. and Europe, as well as being approved for Compassionate
Use by Israel's Ministry of Health. 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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