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news.Preparing to initiate a phase 3 trial by year-end
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Keryx Biopharmaceuticals (Keryx) has initiated phase 2 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL).
KRX-0401 (perifosine) is a novel oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway and several other key signal transduction pathways in both hematologic and solid tumor cancers.
Reportedly, the single-center, open-label study is entitled, “Phase 2 Trial of Perifosine in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,” and will enroll approximately 30 patients.
The company said that in the study, perifosine will be given orally at a dose of 50mg twice daily, for a total of six 28-day cycles. The patients will be formally restaged upon completion of the trial. Overall Response Rate is the primary endpoint with overall survival, progression-free survival and safety as secondary endpoints. Correlative studies will also be conducted and evaluated as a secondary endpoint.
Moreover, Keryx is preparing to initiate a phase 3 trial by year-end, under Special Protocol Assessment (SPA), for patients with advanced multiple myeloma.
Ron Bentsur, CEO of Keryx, said: “We’re very excited to explore the potential of perifosine in this advanced CLL/SLL setting, based on the pre-clinical work completed by Weinberg. We are extremely grateful to the Duke Comprehensive Cancer Center for conducting this study, and we look forward to working with Friedman, Weinberg, Lanasa and their team of renowned oncologists on this phase 2 study.”