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Keryx Biopharmaceuticals Inc. Message Board

paleodrome 1 post  |  Last Activity: Sep 13, 2014 12:23 PM Member since: Nov 10, 2011
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  • Here is a post from the other ("civilized") Ohr board:

    The paper was well received, with a few questions raised primarily for clarification. No new information, just well summarized data.

    Of 142 enrolled patients, this pre-specified, interim analysis was performed when 50% (N = 62) of the planned 120 enrollment had completed the 9 month study. The final analysis will be performed after all 142 patients have completed the 9 month study, likely in early 2015.

    At the time of this interim analysis, the primary endpoint was not met, with a mean of 6.2 injections for the squalamine + Lucentis combination group vs. 6.4 injections for the Lucentis monotherapy group.

    At 9 months, the squalamine + Lucentis group gained 10.4 letters vs. 6.3 letters gained for the Lucentis monotherapy group (p = 0.18). This is not statistically significant, and it means there is an 18% chance that this result occurred simply by chance.

    The most striking part of the paper was the statistically significant superiority of squalamine + Lucentis combination therapy over Lucentis monotherapy, when vision gains were analyzed by group:

    3+ lines VA gained: 48.3% squalamine + Lucentis vs. 21.2% Lucentis
    (p = 0.025)

    4+ lines VA gained: 27.6% squalamine + Lucentis vs. 6.1% Lucentis

    This is amazing data! Several of the doctors present commented that they were a bit surprised about the relatively subdued buzz regarding this data.

    It looks like squalamine is shaping up to be an effective adjunctive treatment to Lucentis, perhaps not a replacement for Lucentis. The current patient experience of monthly injections, followed by a treat and extend regimen will be maintained. The addition of a BID topical medication such as squalamine should be readily accepted by patients. If OHRP can price topical squalamine attractively, it should be wildly successful.

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