PETACH TIKVA, Israel--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today it has been granted patent allowance in South Korea for its patent titled, "An A3 adenosine receptor ligand for use in treating ectopic fat accumulation" for its drug candidate Namodenoson. The main claim among others is the ability of Namodenoson to improve non-alcoholic steatohepatitis (NASH) accompanied by fibrosis.
Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS) of South Korea, has licensed the distribution rights to Namodenoson in South Korea for the treatment of liver cancer and NASH in a deal totaling $6 million in upfront and milestone payments, plus a transfer price for delivering finished products to CKD. The Company has received $2 million from CKD to date for Namodenoson in the treatment of liver cancer and NASH.
Can Fite plans to release data from its Phase II study of Namodenoson in NASH patients during this quarter. The multicenter, randomized, double-blinded, placebo-controlled, dose-finding efficacy and safety study has enrolled 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH. Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 mg or 25 mg of oral Namodenoson, or placebo for 12 weeks. The primary endpoint of the Phase II study is the anti-inflammatory effect of the drug, as determined by mean percent change from baseline in ALT blood levels and safety. Secondary endpoints include percentage change from baseline of liver fat, as measured by MRI-PDFF (proton density fat fraction).
“The notice of allowance for this patent application secures Can-Fite’s proprietary rights in a commercially very important country, South Korea, for an indication where there is a high market need”, said Dr. Pnina Fishman, the Company’s CEO. “We look forward to reporting our topline results during this quarter.
Namodenoson has been also out-licensed for the indication of NASH in China. There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: 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 currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson 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 the Company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. 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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