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Perifosine Approved For FDA Fast Track

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Perifosine Approved For FDA Fast Track

I get a lot of my drug related news from business Websites. Here is an article I read today on RTT News about a new myeloma drug, perifosine:

RTTNews) – Keryx Biopharmaceuticals Inc. (KERX: News ) Wednesday said the FDA has granted Fast Track designation for its KRX-0401 or perifosine indicated in the treatment of relapsed/refractory multiple myeloma. Keryx shares gained more than 13% in intra-day trading following the news.

The Fast Track program is designed to expedite review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Keryx expects to commence a phase 3 trial investigating perifosine in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma by the year-end under a Special Protocol Assessment.

KRX-0401 is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS: News , AEZ.TO) in the United States, Canada and Mexico. The investigational drug is also under phase II clinical development for multiple tumor types.

Here is more about general info about the drug from another business/financial related site, PRNewswire.Com:

About KRX-0401 (Perifosine)

KRX-0401 (perifosine) is a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, and a number of other key signal transduction pathways, including the JNK and MAPK pathways, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. The effects of perifosine on Akt are of particular interest because of the importance of this pathway in the development of most cancers, with evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy, and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity. High levels of activated Akt (pAkt) are seen frequently in many types of cancer and have been correlated with poor prognosis.

You can understand why the financial world is “abuzz” over this news. Sounds like company has bigger cancer fish to fry than just myeloma! Hey! As long as it works, right! Feel good and keep smiling! Pat