Phase 1 & 2 Data of Perifosine (KRX-0401) in Patients with Advanced Renal Cell Carcinoma Presented Today at the 25th Annual Chemotherapy Foundation...(RCC Update All Patients ...),Health

Enrolled, all tumor types 416 205 211

Renal Cell Carcinoma 24 12 12

Evaluable for response 13 7 6

Partial responses (RECIST) 4 (Duration 4, 6.5, 9, 12 mo's) 2 2

Time to Progression > 6 mo's 4 (10, 13, 14, 18+ mo's) 3 1

Times with '+' meaning patient still stable or responding at time of analysis.

Additional renal patients will be enrolled on this study, including patients with prior exposure to sorafenib and sunitinib. Keryx also has two multi-center phase 2 trials underway evaluating perifosine 100 mg as a single agent in pts who have failed a prior TKI (sunitinib or sorafenib), with one of the studies allowing pts who have also failed prior mTOR. Data from these phase 2 TKI failure studies will be presented at upcoming meetings.

Phase 1 Combination Perifosine + Sorafenib - Protocol 124

Eighteen patients with advanced cancers were enrolled in one of four cohorts. Ten of these patients had advanced RCC with some patients having received a prior TKI. No grade 4 toxicities were reported and 1 grade 3 hand/foot syndrome has been seen. The combination has been generally well tolerated. The phase I will enroll an additional 20 patients to confirm the selected MTD.

"The data presented here today further demonstrates perifosine's promising activity as a single agent. The combination of perifosine with sorafenib is of great interest and further exploration with this combination in patients who fail a prior TKI is warranted," stated Dr. Robert Figlin, who continued, "We are anxious to further explore the potential of perifosine, either in comparison to, or in combination with sorafenib, in patients with advanced RCC."

I. Craig Henderson, MD, President of Keryx Biopharmaceuticals, commented, "Perifosine is clearl
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