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Medgenics, Inc. Message Board

  • siciliankan siciliankan Mar 15, 2013 4:30 AM Flag

    Blockbuster News

    There are lots of gems in the results issued yesterday which no news release or summary has picked up on. Most important to me is the following:

    " In the interim we have commenced a phase IIa study of EPODURE in dialysis patients with ESRD in Israel as our first use of EPODURE in patients with complete renal failure, and a forerunner to the U.S. phase II study. To date, four patients have been enrolled and the preliminary results look comparable to our completed CKD study."

    Read that again. You will see that they have slipped in at page 14 of the results that EPODURE is working to the same extent on dialysis patients as non-dialysis patients.

    This is very, very important news as it will open up EPODURE to a new high revenue earning income stream. Remember the CKD results when reading this:

    "The FDA issued a new guidance in 2011 indicating that hemoglobin should be maintained below 11 g/dl and high enough to avoid the need for increased transfusions, but not necessarily above 10 g/dl. In view of this new guidance, we note that the results of the completed study in 19 CKD patients showed that a single EPODURE administration elevated and maintained hemoglobin levels above 9 g/dl for at least three months in 14 of 19 patients, and for at least six months in nine of them, without need for any transfusions or EPO injections. The final study report of the CKD trial should be complete by end of the first quarter of 2013. With respect to our phase I/II study in ESRD patients, the initial early data obtained in the first three patients treated showed evidence of EPO secretion and early maintenance of hemoglobin levels."

    Hmm, so only two more weeks to go before CKD final trial results too. Could be an interesting two weeks.

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