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Regenerx Biopharmaceuticals Inc. Message Board

  • snogreen snogreen Aug 13, 2011 4:31 PM Flag

    Good trial design, tidbit

    I found what I think some good news. I think Ora Inc is choosing patients with teh best chance of seeing efficacy.unlike wht RGRX did in the Pressure and Venous ulcer phase 2's wherte they STPIDLY dosed Stage 4 ulcers..which were all but uncurable. So now teh world thinks TB 4 will fail again. maybe not. in the trial design, for INCLUSION in the study they want this:

    <<Have a corneal fluorescein staining score of ≥ 2 in any corneal surface segment in at least one eye at Visit 1.

    I foudn a website to explain some of this florescein staining score and who these patients are. here is a summary sentance:

    "The Efron system uses one variable, the degree of staining per zone based on an ordinal scale of 0 to 4: 0=no staining, 1=trace staining, 2=mild staining, 3= moderate staining, 4=severe staining. The Efron system has been validated for clinical use with an expected accuracy of 1.2 grading scale units, a rather large range of error for a four-point scale."

    A grade 2 staining is mild. Grade 3 moderate. Grade 4 is severe. Irt reads to me like Ora Inc will be chosing patients with mild or moderate staining. Which is TB 4's best chance of success. if they were choosing teh SEVERE patients, they woudl stat that for inclusion you need Grade 3 or higher to grade 4.

    Since Dry Eye is such a common and widspread thing, there is plenty of demand for therapies that address the mild to moderate cases of dry eye.

    THANK GOD that RGRX is finally getting a trial dsign that is right. Dosing teh mild to moderate cases of dry eye gives us the best shot at efficacy......

    Here is full site:

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