A great update from Mark Day in my opinion. I'm not exactly happy with all of the content, but it was a very well-written thorough update. No mention of the LSD program or Scarpa collaboration in the news release though. That is strange. The follow up study for the Scarpa LSD project to find the optimal dose should have been done by now. We still need an update on the LSD program.

With regards to the non-human primate (NHP) studies, I am happy to see that they will be doing the NHP studies. I previously brought up the issue of the need for NHP studies. These studies will bolster the confidence for advancing internal programs into humans, and also provide the company with much needed example data to show to companies that may want to license Mtfp. A great move. A wise move. I am assuming that biOasis has not done any NHP studies yet prior to the Mark Day era. Too bad it took so long for the company to make this decision, but very glad that this decision has now been made with Mark Day at the helm.

As for the timeline of the Phase 0 Mtfp-trastuzumab trial, I have mixed feelings. I am happy to hear Mark Day's candid statement about the plan, but am very frustrated and disappointed with the timeline. The news release states:

"We have already selected a manufacturer to produce the clinical-grade fusion proteins required for the study. The development of the cell line to produce the fusion protein and the manufacturing of the required quantity of the drug will take up to a year to complete."

I am not frustrated at Mark Day, but I am frustrated with the pre-Mark Day biOasis. Over a year ago (June 8th to be exact) Rob Hutchison replied to my e-mail inquiry regarding internal programs:

"We are working on our LSD program with Scarpa and are in the midst of a dosing study, but that data is not out yet.  As for our oncology program we are in the process of preparing for a phase zero study, but the timing for that is predicated on material prep and patient availability."

The January 30, 2017 MD&A stated:

"In this regard, plans are underway to perform a Phase Zero Phase study for measuring BBB transport of MTfp-TZM in humans.... The Company is pushing forward on two internal programs, one with Dr. Scarpa on MPSII and the Trastuzamab program with the Phase Zero team in Australia. Although both of these programs have caught the interest of Pharmas, we as a company are focused, pending adequate financial resources, to moving forward with both programs in humans. Extensive protocols have been designed and approved and both Dr. Scarpa and the Phase Zero team in Australia are ready to begin these studies."

So up to a year to prep the material to start the Phase 0 Mtfp-trastuzumab trial? Glad those extensive protocols are approved though! Relax Phase Zero team in Australia.......we won't be ready for you for some time! 

BearDownAZ