Maria’s quoted email
"With the funds raised we will be able to progress to a pre-IND meeting by completing (human in vitro) tissue cross reactivity and single dose toxicity studies (page 1 of our newsletter). These are significant milestones and go towards de-risking the program. As you point out toxicity is one of the areas we need to address and these will be the first ever formal toxicology studies of our antibody.
We have released the approximate timing of the pre-IND meeting as mid 2015 although it will depend on many factors, some outside of our control, like the FDA. On the other hand, the timing of the clinical trials will depend on availability of funding, manufacturing timetables, clinical facilities etc. Hence it is not possible to commit to a timeline at this stage on this front. "
Based on previous announcements this all reads well to me.
There are generic timelines and probabilities of success that can be pulled down from the internet but this study is not generic and any article that you read needs to be recent if it is to be relevant.
Any hope of meeting the FDA mid year would be predicated on the study milestones (mentioned above) being well under way. It takes the FDA about 30 days to review an IND application and it would (in my uninformed opinion) be silly to proceed with further manufacture of the antibody or clinical trial recruitment until the FDA advice and guidance is received.
I don't know not how long it will (likely) take Rodan to complete the antibody batch necessary to support the first stages of the open label study. Maybe someone else on the thread could make an educated guess opinion but this task would I expect take a few months ........ noting also that mABs have efficacy shelf lives ...... so time between batch completion and the clinic may need be relatively short.
Looking at the timeline suggested at the AGM the company appears to be sort of on it .... maybe a few months slippage .... but Maria is still talking mid-year so all in all it's not too bad. We may need to consider a time contingency of a quarter's slippage and the very least for this kind of thing.
The better news is that once the open label study commences it will be short in duration (2 quarters) and the results will be known quickly. When the study moves to a full Phase II mode (with the MK mAB likely used in combination with other chemo drug(s) at this point) results should also become apparent quickly (as they were in the mouse model). Tumors will either shrink rapidly (as they did in the mice) or they won't.
On probability of success ..... what worked for mice should work for men IMHO because of the limited (conserved) role and function of midkine ..... and ..... because no cross reactivity was reported in mouse studies . In this respect the proposed MK mAB differentiates itself from most other mABs (and similars).
This is the study I have been waiting for. The study and trial is not risk free but from my personal investment perspective the risk is well within my personal risk tolerance levels for the reasons stated.
It would be great if a more knowledgeable person could add to this.
(20min delay)