AEterna Zentaris Inc. (AEZS, AEZ.TO) announced that its partner, Keryx Biopharmaceuticals (KERX), presented updated results on the clinical activity of perifosine or KRX-0401, the Company's PI3K/Akt pathway inhibitor for cancer, in combination with capecitabine (Xeloda) as a treatment for advanced, metastatic colon cancer.
In this randomized, double-blind, placebo-controlled study conducted at 11 centers across the United States, heavily pre-treated patients with second- or third-line metastatic colon cancer were randomized to receive capecitabine at 825 mg/m2 BID (total daily dose of 1,650 mg/m2) on days 1 - 14 every 21 days plus either perifosine or placebo at 50 mg daily.
The study enrolled a total of 38 patients, 34 of which were third-line or greater. Of the 38 patients enrolled, 35 were evaluable for response (20 patients on the perifosine + capecitabine arm and 15 patients on the placebo + capecitabine arm). Three patients on the placebo + capecitabine arm were not evaluable for response (2 patients were unevaluable due to toxicity (days 14, 46) and 1 was unevaluable due to a new malignancy on day 6).
The patients in the study were heavily pre-treated, with the arms well-balanced in terms of prior treatment regimens. The median number of prior treatment regimens for all 38 patients was two, with prior treatment regimens for the P-CAP arm versus CAP arm shown in the table below. Notably, all of the patients , with the exception of one CAP arm patient, had been treated with FOLFIRI and/or FOLFOX, almost 80% treated with Avastin, and half treated with an EGFR antibody.
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