Aeterna Zentaris has presented the Phase 2 data of perifosine, its lead novel oral anti-cancer compound, showing promising clinical activity, safety and tolerability in patients with advanced chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL).
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Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway.
The product works by interfering with membranes of cancer cells thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival.
In the Phase 2 study, 26 patients were enrolled with advanced lymphoma (6 NHL, 4 CLL, 1 Waldenstrom’s Macroglobulinemia and 15 Hodgkin’s lymphoma).
Aeterna Zentaris said all of the 4 CLL patients in the study achieved a partial response on single-agent perifosine within one month of treatment and remained on perifosine single agent.
Response durations for each of the 4 patients were 4, 8, 9+ and 12 months. The remaining 22 patients were administered the combination with sorafenib, where 5 of the 15 (33%) Hodgkin’s lymphoma patients achieved a partial response with a median response duration of 9 months.
An additional 6 patients receiving the combination (40%) achieved stable disease. The combination was well tolerated with no unexpected safety events.
In another Phase 2 study, 12 patients with advanced CLL began treatment with single agent perifosine at 50 mg BID.
Patients on study were heavily pre-treated having had a median of 4 prior lines of therapy with 75% of patients classified as Rai stage IV.
Aeterna Zentaris president and CEO Juergen Engel said the encouraging data in advanced leukemia and Hodgkin’s lymphoma presented at the ASH meeting, confirm perifosine’s efficacy and safety as a novel, oral anti-cancer agent not only in combination therapy with approved anti-cancer agents but also as a single agent therapeutic.
"Data also showcase perifosine’s potential beyond the current Phase 3 registration trials in metastatic colorectal cancer and multiple myeloma," Engel said.
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