Can-Fite Signs Distribution Deal for Liver Cancer Drug CF102 in South Korea
PETACH TIKVA, Israel, Oct. 25, 2016 /PRNewswire/ -- 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 it has signed a distribution agreement with Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS) for the exclusive right to distribute CF102 for the treatment of liver cancer in South Korea, upon receipt of regulatory approvals, for up to $3,000,000 in upfront and milestone payments, plus a percentage rate of royalties on net sales in the low twenties. The distribution agreement further provides that Can-Fite will deliver finished product to CKD and grants CKD a right of first refusal to distribute CF102 for other indications for which Can-Fite develops CF102.
"This agreement marks our first distribution deal for CF102 as we near completion of patient enrollment in our Phase II trial of CF102 as a second line treatment for hepatocellular carcinoma. The pressing need for an effective drug in this difficult to treat cancer makes CF102, in our opinion, a strong potential candidate as we look towards Phase II results and ahead to Phase III in the U.S. where CF102 has Fast Track Designation in this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We look forward to working with CKD to advance CF102 in South Korea."
Approximately, 51,000 people had liver cancer in Korea, with approximately 11,000 deaths in 2012 according to a study published in Cancer Research and Treatment: Official Journal of Korean Cancer Association in 2015.
Can-Fite is currently conducting a global Phase II double-blind, placebo controlled study evaluating the efficacy of CF102 as a second-line treatment for advanced HCC. The primary endpoint is overall survival. In the coming quarters, Can-Fite intends to initiate a Phase II study of CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).
This agreement with CKD marks Can-Fite's second distribution and licensing deal in South Korea, where the Company's Piclidenoson (CF101) has already been out-licensed to Kwang Dong Pharmaceutical Co. for the treatment of rheumatoid arthritis.
About CF102
CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells. Based on preclinical data showing CF102 has strong liver protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has received Orphan Drug Designation for CF102 in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.
PETACH TIKVA, Israel, Oct. 25, 2016 /PRNewswire/ -- 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 it has signed a distribution agreement with Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS) for the exclusive right to distribute CF102 for the treatment of liver cancer in South Korea, upon receipt of regulatory approvals, for up to $3,000,000 in upfront and milestone payments, plus a percentage rate of royalties on net sales in the low twenties. The distribution agreement further provides that Can-Fite will deliver finished product to CKD and grants CKD a right of first refusal to distribute CF102 for other indications for which Can-Fite develops CF102.
"This agreement marks our first distribution deal for CF102 as we near completion of patient enrollment in our Phase II trial of CF102 as a second line treatment for hepatocellular carcinoma. The pressing need for an effective drug in this difficult to treat cancer makes CF102, in our opinion, a strong potential candidate as we look towards Phase II results and ahead to Phase III in the U.S. where CF102 has Fast Track Designation in this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We look forward to working with CKD to advance CF102 in South Korea."
Approximately, 51,000 people had liver cancer in Korea, with approximately 11,000 deaths in 2012 according to a study published in Cancer Research and Treatment: Official Journal of Korean Cancer Association in 2015.
Can-Fite is currently conducting a global Phase II double-blind, placebo controlled study evaluating the efficacy of CF102 as a second-line treatment for advanced HCC. The primary endpoint is overall survival. In the coming quarters, Can-Fite intends to initiate a Phase II study of CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).
This agreement with CKD marks Can-Fite's second distribution and licensing deal in South Korea, where the Company's Piclidenoson (CF101) has already been out-licensed to Kwang Dong Pharmaceutical Co. for the treatment of rheumatoid arthritis.
About CF102
CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells. Based on preclinical data showing CF102 has strong liver protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has received Orphan Drug Designation for CF102 in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.
