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Sunday, August 28, 2016 7:29:42 PM
Ibalizumab is administered via IV not subcutaneous and is for terminal patients (very small market). CytoDyn believes that the subcutaneous formulation is in Phase 1.
Ibalizumab is administered at the hospital once every two weeks and following infusion the patient's energy level can be very low because this product binds to CD4 receptor of all cells that have CD4.
Please see below chart of PRO 140 versus Ibalizumab and note the following: It takes 10mg/kg of Ibalizumab to reduce the viral load (VL) to about 1.4log after 14 days. With PRO 140 it took 10 days to reduce the VL to 1.7 log (the max which is not included on the curve was 2.5log). To put this into perspective, 1.4log represents about a 25 folds drop in VL and 2.5log is about 318 folds drop in VL.
Further, it took only 14 more days for VL following treatment with Ibalizumab arm to return to the original level but with PRO 140 it took another 50 days.
With 3 mg/kg the Ibalizumab VL drop is (at its Nadir level) .5log with PRO 140 5mg/kg the nadir is 1log (more than three times potent- [.5log = 3 fold, 1log = 10 fold drop].
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