Phase 1 & 2 Data of Perifosine (KRX-0401) in Patients with Advanced Renal Cell Carcinoma Presented Today at the 25th Annual Chemotherapy Foundation...(DLT's were observed and extra patients w...),Health

Date:11/9/2007

DLT's were observed and extra patients were enrolled to confirm the last two cohorts. The study will move into Part 2 where an additional group of up to 20 patients will be accrued and treated at the determined MTD in order to determine a Phase II dose that will allow patients to remain on-study for at least 12 weeks. The effects of the combination of perifosine and sorafenib will be evaluated for response rate and time to progression in both parts of the study.

Toxicity

Both, the 50 mg and 100 mg dose have been well tolerated. The main toxicities are nausea, vomiting, diarrhea, and fatigue. In a pooled analysis, % of patients on the continuous daily dose of 50 mg or 100 mg with no GI toxicity was as follows:

% with NO Gastrointestinal Toxicity

50 mg Daily 100 mg Daily

Adverse Event N = 141 N = 68

Nausea 57% 63%

Vomiting 70% 74%

Diarrhea 61% 69%

Perifosine (KRX-0401) Mechanism of Action and Profile

Perifosine has been shown to inhibit or otherwise modify signaling through a number of different signal transduction pathways including Akt, MAPK, and JNK. Akt isoforms have been found to be overexpressed in renal, breast, prostate, and pancreatic cancers. Elevated levels of pAkt have been correlated with poor prognosis in patients with gastric, hepatocellular, endometrial, prostate, renal cell and head and neck cancers, as well as glioblastoma. The majority of tumors expressing high levels of pAkt were high-grade, advanced stage or had other features associated with poor prognosis.

The effects of perifosine on Akt are of particular interest because of 1) the importance of this pathway in the development of most cancers; 2) the evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy; and 3) and the difficulty encounter
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SOURCE Keryx Biopharmaceuticals, Inc. Copyright©2007 PR Newswire. All rights reserved

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