Keryx Updates Single Agent Phase 2 Data Of KRX-0401

Keryx Biopharmaceuticals has announced updated clinical results from a phase 2 study of KRX-0401 (perifosine), the company’s PI3K/Akt pathway inhibitor for cancer, as a single-agent treatment for advanced metastatic renal cell carcinoma (RCC).

The company said that Evaluable patients (n=16) were defined as those who had greater than 7 days of treatment (2 additional patients withdrew consent within 7 days). Patients received 100 mg of perifosine daily until progression or unacceptable toxicity. The primary endpoint of the study was clinical benefit, defined as response rate (CR / PR by RECIST) or percent of patients progression-free for at least 3 months. Median progression-free survival (PFS) and overall survival were also analyzed for efficacy.

Ron Bentsur, CEO of Keryx Biopharmaceuticals, said: “We continue to be encouraged by the single agent activity of perifosine in the treatment of advanced renal cell carcinoma. While preliminary, perifosine’s response and PFS data presented appear equivalent to that of other agents for advanced RCC, which were approved in a less heavily pre-treated patient population. We look forward to evaluating future perifosine trial designs with Mr. Hutson, Mr. Vogelzang and other RCC experts.”