Digitel on the Stockhouse board asked a series of questions yesterday asking whether there have been studies of long-term (>1 yr) administration of Mtf or Mtfp or if studies have been performed in a higher order mammal. To the best of my knowledge, which is very limited since I haven't followed biOasis as long as many of you, the longest disclosed studies of Mtf or Mtfp administration have been 5 weeks (Herceptin/Trastuzumab) or 6 weeks (Idursulfase/I2S). I have no problem with this. The goal of those rodent studies was to show that transport and efficacy across the blood brain barrier was achieved. Check.

To the best of my limited knowledge, all disclosed studies have been in cells or in mice. It would be quite surprising to me if biOasis goes directly from mice to humans without any other studies in other animal models. Furthermore, I expect that a non-human primate model would be utilized by biOasis prior to proceeding to human studies. For example, Armagen has done studies in Rhesus macaque primates prior to proceeding to human studies. So with the rumored talk of a Phase 0 human study and biOasis taking the Herceptin/Trastuzumab program to the clinic on their own, the question about validation in other animal models is very relevant. I'd be interested to hear others opinions on this.

BearDownAZ