Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Ra...(udio.financialcontent.com/Engine?Account...),Health

ABOUT KRX-0401 (Perifosine)

KRX-0401 (perifosine) is a novel, first-in-class, oral anticancer agent that modulates AKT and a number of other key signal transduction pathways, including the MAPK and JNK pathways all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival.

High levels of activated Akt (pAkt) are seen frequently in many types of cancer and have been correlated with poor prognosis in patients with soft- tissue sarcoma, gastric, hepatocellular, endometrial, prostate, renal cell, head and neck cancers and hematological malignancies, 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. High pAkt is often seen in tumors that are resistant to conventional cancer treatments, including radiotherapy, chemotherapy, endocrine therapy, and especially therapy with some of the newer biologicals.

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 encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity. It is plausible that perifosine may be useful in combination to reduce the resistance to other cancer treatments.

To date, over 1,200 patients have been treated with perifosine in trials conducted both in the United States and Europe. Its safety profile is distinctly different from that of most cytotoxic agents. It does not appear
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