Hi Pete! In a material transfer agreement - the a

Hi Pete!

In a material transfer agreement - the agent can't be changed or modified in any way - so it will be exact same form as ctix has used from the beginning.

For the in vitro testing - they use isolated purified cells from specific cancers (research institutions have repositories of specific cancer and tumor cell lines) smeared on special slides called tissue culture dishes and add minute doses of the agents being studied. If they see inhibition of cancer cell growth - they pursue further testing using multiple doses and combos. This initial screening often utilizes up to 60 different cancer types so it can take a while. There is nothing preventing MDA from starting mouse studies almost in concert with the cell assays. Once they see anti-proliferative effects and quantify the concentration effect relationships of the drugs being tested - they can get the mice out.

As part of a material transfer agreement - MDA has to have one scientist in charge of receipt of materials and that same scientist supervising all of the assays and lab personnel and testing. Basically - to do something like this - MDA had to wait for a lab to open up to be a dedicated space for this agent (K was in 'queue' again!). The confidentiality clauses of an MDA like this requires dedicated space and personnel. This delays start of such a big undertaking - but makes things move more quickly after research is initiated.

And just an fyi - an mta from a company with a novel proprietary agent is an extremely complex contract to create and the process usually takes months and sometimes longer.

It can be very hard to make a pill form of many drugs. The testing would need to start from the very beginning and evolve thru human trials as it would be processed by the body and liver differently than IV formulation.