On February 22, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has submitted annual safety summaries for 2017 on both Piclidenoson and Namodenoson to regulatory authorities around the world (Filing, 6-K, Can-Fite BioPharma, FEB 22, 2018, View Source [SID1234524124]).
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The safety reports, known as Development Safety Update Reports (DSURs), are required annually and serve to create timely and transparent communication between drug development sponsors and regulatory agencies. The DSURs summarize safety data from all clinical trials conducted during the year-long reporting period. Can-Fite is pleased to note that both of its molecules under clinical development continue to demonstrate favorable safety profiles in human clinical trials.
In the DSUR for Piclidenoson, Can-Fite notes that there were no deaths, serious adverse events (SAEs), serious adverse reactions (SARs), or suspected unexpected SARs (SUSARs) related to the use of the drug to treat inflammatory diseases during 2017. Furthermore, over the span of development, an estimated 1167 human subjects have received Piclidenoson, without evidence of emerging treatment-limiting toxicities. The Namodenoson development program includes patients with advanced hepatocellular carcinoma (liver cancer), in whom serious adverse events, cancer progression, and mortality are expected and occurred; nevertheless, despite the underlying illness of this population, no SARs or SUSARs were reported during 2017. To date, an estimated 115 human subjects have been dosed with Namodenoson, again without evidence of novel safety concerns.
Both Piclidenoson and Namodenoson target the A3 adenosine receptor, overexpressed in pathological but not in normal body cells. This means that when the drugs enter the body they specifically bind to the diseased but not to the normal cells. This unique drug characteristic is believed to account for the observed favorable safety profile.
The importance of these favorable data allow the Company to continue with the various clinical indications entailing Piclidenoson for the Phase III study in patients with rheumatoid arthritis and Namodenoson for the Phase II studies in advanced liver cancer and NAFLD/NASH.
Dr. Michael Silverman, Can-Fite’s Medical Director, commented: "Can-Fite’s Piclidenoson and Namodenoson drugs are unique in today’s autoimmune inflammatory, oncology and NASH drugs under development due to their favorable safety profile and the specific anti-inflammatory and anti-cancer effects. We are very happy to continue with our clinical development programs."
About Piclidenoson (CF101)
Piclidenoson 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 (Phase III ongoing) and psoriasis (completed Phase II/III).
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). 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.