Phase 1 & 2 Data of Perifosine (KRX-0401) in Patients with Advanced Renal Cell Carcinoma Presented Today at the 25th Annual Chemotherapy Foundation...(y an active drug in the treatment of ren...),Health

Based on the promising data in renal cell carcinoma with perifosine as a single agent and in combination with sorafenib, Keryx Biopharmaceuticals plans to launch a phase 2/3 clinical program in the 1st half of 2008.

About the Phase 2 Trial Design

This company-sponsored, exploratory trial was designed to evaluate the safety and efficacy of two schedules of perifosine (KRX-0401) in patients with a variety of tumor types. From February 2005 to May 2007, 416 patients at over 30 centers across the US were first randomized to receive either 50 mg of perifosine once daily or 1200 mg on a weekly dose schedule and later to either 100 mg daily or 900 mg weekly. Because the daily doses appear to be as effective and clearly less toxic, enrollment continues with randomization between 50 and 100 mg daily. The protocol was designed to accrue 11 patients in a given tumor type and then expand that cohort to 26 patients if a favorable outcome is seen in at least 1 of the first 11 patients. The responses we have seen in this advanced renal cell carcinoma cohort did not appear dose-dependent as partial responses and stable disease were noted in both dose groups. This is consistent with prior data with perifosine where responses have been equally distributed between higher and lower dose groups.

About the Phase 1 Trial Design - Perifosine + Sorafenib

This company-sponsored trial was designed to evaluate the safety (Part 1) of perifosine in combination with sorafenib for patients with advanced cancers. Perifosine is escalated from 50 mg qd to 50 mg tid while sorafenib is escalated from 400 mg qd to 400 mg bid. From September 2006 to October 2007, 17 patients at 6 centers across the US were enrolled into one of the four cohorts. No
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