Phase 1 & 2 Data of Perifosine (KRX-0401) in Patients with Advanced Renal Cell Carcinoma Presented Today at the 25th Annual Chemotherapy Foundation...( Oral Presentation by Dr. Robert Figl...),Health

Oral Presentation by Dr. Robert Figlin Highlights Phase 2 Data Showing 31% Partial Response Rate and a 62% Overall Clinical Benefit Rate to Perifosine Used as a Single Agent and Phase 1 Data Showing No Evidence of Increased

Toxicity When Combined with Sorafenib

NEW YORK, Nov. 9 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced positive phase 1 & 2 data of perifosine (KRX-0401) in patients with advanced renal cell carcinoma (RCC). In an oral presentation entitled "PERIFOSINE: AN ORAL, AKT INHIBITOR WITH CLINICAL ACTIVITY IN ADVANCED RENAL CELL CARCINOMA," Dr. Robert Figlin, Medical Oncology Chair and Professor of Medicine, City of Hope National Medical Center in Duarte, CA provided an update on the clinical activity of single agent perifosine from a phase 2 trial (Protocol 207), and reported on the safety and efficacy of perifosine in combination with sorafenib from an ongoing phase I study (Protocol 124).

Phase 2 Single Agent in RCC - Protocol 207

Twenty-four patients with advanced renal cell carcinoma (RCC) were randomized to either the daily (50 mg or 100mg) or weekly (900mg or 1200mg) dose of perifosine. Patients with measurable disease who received at least 2 courses of perifosine and at least one tumor measurement after initiation of perifosine, were considered evaluable for response using RECIST criteria. Thirteen were evaluable for response. Four of these (31%) had a partial response and an additional 4 patients (31%) achieved long-term stable disease for a 62% overall clinical benefit rate. Five patients progressed. One of the responding patients had previously failed to respond to both sorafenib and sunitinib. The results are as follows:

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100 mg 900 mg

Protocol 207
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