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news.Aeterna Zentaris has completed patient recruitment for its European multi-center Phase II trial in non-small cell lung cancer with perifosine, a novel, first-in-class, oral signal transduction inhibitor.
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The primary endpoint of this trial is the extent and duration of local control, that is, the absence of tumor recurrence or progression in the area that has been irradiated. Patients receive perifosine daily for five to six weeks, starting seven days prior to radiotherapy, and are followed for at least 12 months.
This randomized, double-blind, placebo-controlled trial will assess the efficacy and safety of a 150mg daily dose of perifosine when combined with radiotherapy in 160 patients with inoperable stage III non-small cell lung cancer. The trial is being conducted in collaboration with the Netherlands Cancer Institute.
Perifosine is an oral anti-cancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells.
David Mazzo, president and CEO of Aeterna Zentaris, said: “We are pleased to have completed enrollment for our Phase II trial with perifosine in combination with radiotherapy. Patients will be followed for a one-year period after receiving treatment, and therefore, we expect to announce top-line results at the end of 2008.”