Summary observations from PBB's blood factor trials
PBB achieved a world first in correcting the whole-blood clotting times of naturally haemophilic dogs to normal via a low-volume subcutaneous injection. As expected, unmodified proteins that were administered subcutaneously in the same studies (and at equivalent dose levels) were ineffective in providing haemostatic cover.
Naked Expected PBB protein PBB protein Extension of Protein Blood Haemostatic Haemostatic duration of Haemostatic Subcutaneous Factor cover (i) cover (i) Haemostasis Cover Bioavailability FVIIa 0 hrs 72 hrs --lemniscate 168+ hrs 89% FVIII 0 hrs 72 hrs --lemniscate 168+ hrs 40% (ii) FIX 0 hrs 240 hrs --lemniscate 336 hrs 86%
(i) The duration of "cover" is the time over which a whole blood clotting time of less than 12 minutes could be maintained
(ii) FVIII bioavailability figure reflects a minimum measurement (based on assays for the existing native protein) that is expected to improve as PBB develops specific assays for the new, improved protein.
Further extensions in duration of cover with the subcutaneous products are confidently expected since the Cmax of the subcutaneous products is significantly lower than for the intravenous products, providing plenty of scope for safe dose increases and further product optimisation.
Long-acting intravenous products are ideal for trauma applications including surgical and post-surgical treatment. PBB's modified blood factors clearly outperformed the currently available products (naked protein) in all trials.
Current PBB Expected PBB Naked protein protein Extension of Protein Blood Ha
|SOURCE Pro Bono Bio|
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