CANF-Can-Fite Gears Up for ACRobat, its Phase III Trial of Piclidenoson in Rheumatoid Arthritis
PETACH TIKVA, Israel, Feb. 8, 2017 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today the Company is ready to commence patient enrollment in the second quarter of 2017 in its global Phase III trial of its lead drug candidate Piclidenoson as a first line treatment for rheumatoid arthritis. The trial, titled ACRobat, will enroll approximately 500 patients in Europe, Canada and Israel.
The estimated cost of the entire Phase III study is approximately $5 million. This includes the cost of the global clinical research organizations that have been engaged to help conduct ACRobat. The required supply of Piclidenoson has already been manufactured and paid.
Piclidenoson is being developed as a first line therapy and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The primary endpoint of ACRobat, a randomized, double-blind, active and placebo-controlled study, is low disease activity after 12 weeks of treatment in patients dosed with Piclidenoson compared to those dosed with MTX. Piclidenoson at 1 mg and 2 mg, or placebo, will be administered twice daily, and MTX or placebo will be administered once weekly. The total study duration will be 24 weeks in order to provide more data on long term efficacy and safety.
"We are eager to commence our Phase III rheumatoid arthritis trial in the second quarter. We believe Piclidenoson can offer a superior alternative to MTX, which is used at some point by approximately 90% of rheumatoid arthritis patients. MTX is an oncology drug known to induce severe adverse events. Piclidenoson's well established and excellent safety profile, as demonstrated in previous clinical studies in more than 1,000 patients, combined with a potential for efficacy equal to or better than MTX, positions Piclidenoson as a potential future first line therapy of choice for doctors treating rheumatoid arthritis," stated Can-Fite CEO Dr. Pnina Fishman.
Although approximately 90% of rheumatoid arthritis patients receive MTX at some point in their disease according to the Arthritis Foundation of America, 40-50% of patients stop taking MTX after five years, primarily due to the presence of serious side-effects, as indicated in some published studies. Other studies show that between 10% and 30% of patients are intolerant of MTX, creating a significant need in the market for a new, safe and effective treatment option.
Rheumatoid arthritis is a treatment market forecast to reach $38.5 billion by 2017.
PETACH TIKVA, Israel, Feb. 8, 2017 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, announced today the Company is ready to commence patient enrollment in the second quarter of 2017 in its global Phase III trial of its lead drug candidate Piclidenoson as a first line treatment for rheumatoid arthritis. The trial, titled ACRobat, will enroll approximately 500 patients in Europe, Canada and Israel.
The estimated cost of the entire Phase III study is approximately $5 million. This includes the cost of the global clinical research organizations that have been engaged to help conduct ACRobat. The required supply of Piclidenoson has already been manufactured and paid.
Piclidenoson is being developed as a first line therapy and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis. The primary endpoint of ACRobat, a randomized, double-blind, active and placebo-controlled study, is low disease activity after 12 weeks of treatment in patients dosed with Piclidenoson compared to those dosed with MTX. Piclidenoson at 1 mg and 2 mg, or placebo, will be administered twice daily, and MTX or placebo will be administered once weekly. The total study duration will be 24 weeks in order to provide more data on long term efficacy and safety.
"We are eager to commence our Phase III rheumatoid arthritis trial in the second quarter. We believe Piclidenoson can offer a superior alternative to MTX, which is used at some point by approximately 90% of rheumatoid arthritis patients. MTX is an oncology drug known to induce severe adverse events. Piclidenoson's well established and excellent safety profile, as demonstrated in previous clinical studies in more than 1,000 patients, combined with a potential for efficacy equal to or better than MTX, positions Piclidenoson as a potential future first line therapy of choice for doctors treating rheumatoid arthritis," stated Can-Fite CEO Dr. Pnina Fishman.
Although approximately 90% of rheumatoid arthritis patients receive MTX at some point in their disease according to the Arthritis Foundation of America, 40-50% of patients stop taking MTX after five years, primarily due to the presence of serious side-effects, as indicated in some published studies. Other studies show that between 10% and 30% of patients are intolerant of MTX, creating a significant need in the market for a new, safe and effective treatment option.
Rheumatoid arthritis is a treatment market forecast to reach $38.5 billion by 2017.
