PETACH TIKVA, Israel, Jan. 6, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced its anticipated clinical milestones for calendar 2015.
“We are looking forward to a very active year in terms of clinical developments and release of data from key trials including late stage studies for psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.
Q1 2015 Data release from Phase II/III psoriasis trial
In the first quarter of 2015, Can-Fite plans to announce top line results from its Phase II/III trial of its lead drug candidate CF101 in the treatment of psoriasis. The Company completed enrollment of over 300 patients at 17 clinical centers in the U.S., Europe, and Israel. Previously announced interim results for the first 100 patients were positive. The psoriasis therapeutic market was worth $3.6 billion in 2010 and is forecast to grow to $6.7 billion by 2018, according to estimates of GlobalData.
Q1 2015 Completion of commercial A3AR biomarker blood test kit
In the first quarter of 2015, Can-Fite anticipates completion of its biomarker blood test kit for the A3 adenosine receptor (A3AR) as a biomarker to predict patient’s response to CF101. The kit is designed to test A3AR expression levels prior to treatment with CF101, thereby predicting a patient’s response to the drug and providing more personalized medicine. The U.S. Patent and Trademark Office issued Can-Fite a patent for the utilization of A3AR as a biomarker to predict patients’ response to CF101 in all autoimmune inflammatory indications.
H2 2015 Data release from analysis of Phase II glaucoma trial
During the first half of 2015, Can-Fite expects to announce results from its Phase II study of CF101 in the treatment of glaucoma. The 88 patient study is planned to be conducted in two European countries by Can-Fite’s subsidiary OphthaliX Inc. (OPLI). The global glaucoma market was estimated by GlobalData to be worth approximately $3 billion in 2010 and CF101 is one of only a few oral drugs developed for glaucoma. The market currently consists primarily of generic eye drop drugs. Oral administration is expected to improve patient compliance.
Q4 2015 Completion of patient enrollment for Phase II liver cancer trial
By the end of 2015, Can-Fite anticipates completing enrollment of approximately 78 patients in its Phase II trial for its drug candidate CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. In December 2014, Can-Fite dosed its first patient in the randomized, double-blind, placebo controlled trial to be conducted in the U.S., Europe and Israel. CF102 has been granted Orphan Drug Status by the U.S. Food and Drug Administration and it is also approved for Compassionate Use for Liver Cancer by Israel’s Ministry of Health. According to Global Industry Analysts the global market for liver cancer is projected to exceed $2 billion by 2015.
Q4 2015 Completion of a working plan for Phase I Sexual Dysfunction trial
During 2015 Can-Fite, plans to implement a pre-clinical development program of its next generation drug CF602 for the indication of sexual dysfunction and develop a working plan to file an IND with the U.S. FDA for a Phase I study. In December 2014, Can-Fite received positive pre-clinical data from experimental animal models demonstrating that CF602 improved sexual dysfunction in a dose dependent manner. GlobalData estimates the value of the erectile dysfunction therapeutic market is approximately $2.7 billion with few drugs on the market which includes Viagra, Cialis and Levitra.
