Oslo, Norway-based Clavis Pharma has announced positive results form a Phase II trial of elacytarabine (CP-4055), a drug for late-stage acute myeloid leukaemia (AML). Elacytarabine showed statistically significant efficacy compared to published clinical data for late-stage AML. Median survival for those taking elacytarabine three times longer than those receiving standard care, and remission rate significantly increased as well (15 percent vs 2.5 percent).
Based on the final data from all of the patients in the study, Clavis Pharma is now in the process of designing a pivotal trial of the drug. There is currently no standard therapy available for late-stage AML patients who have failed two previous therapeutic regimens, and life expectancy is very short.
"...[E]elacytarabine has shown prolonged survival, a significant reduction in early mortality and a substantially and unexpectedly higher complete remission rate for these patients compared to previously published experience," said Coordinating Investigator Professor Francis Giles. "Since elacytarabine also is well tolerated by both younger and elderly patients, it has the potential to become the standard of therapy for refractory/relapsed AML. An elacytarabine pivotal trial in this patient population is highly warranted."
- see Clavis' release