Hi to all,
I will try to answer a few questions that I see have been discussed.
1) Can I get tested for MRTCs ahead of the trial?
There is no lab test your neurologist can order to find out if you have MRTCs. Opexa uses their own proprietary T-cell Epitope Analysis Assay (EAA). Opexa is able to determine the patient’s specific set of T-cells (T-cell repertoire) that are reactive to the myelin proteins. Each patient has a unique peptide repertoire, and it is from this repertoire that the patient-specific vaccine is made.
2) Is it delivered refrigerated?
The life span of the vaccine is approximately 4 days. This is long enough to be able to ship it worldwide. The vaccine is alive attenuated T-cells. If the cells get too hot, they will start to die. Dead cells will still elicit an immune response, but the response will not be as good as a response from live cells. That is the difference between the Salk and Sabin polio vaccines.
The T-cells are frozen and thawed during the expansion process, but I don't think that it would be good for the vaccine if the cells were frozen in transport. I think heat is the greater worry, and I believe the vaccine is shipped in a styrofoam container, which should keep the vaccine within a certain temperature range during transit.
3) News about Opexa
The company just finished raising about $8 million. I believe only 3 brokerage firms were allowed to handle the offering and you would have needed an account at one of those firms to participate. I have mentioned before that when a company reports a going concern, that indicates that they do not have sufficient funds for the next 12 months. You will see this reported periodically and indicates that there will be another fund raising before long.
4) Will there be any trial outside of the US?
Eventually, but the current focus is on US FDA approval. When there is more money, there will be sites in other countries.
5) Must someone product the required MRTCs just like the initial enrollment to make vaccine for the extension study?
Yes. If you were able to produce MRTCs and are in the placebo group, I assume you are still producing MRTCs, unless since the initial testing, you have added something that suppresses T-cells. If you were in the Tovaxin group, you could be one of those lucky few who go into remission. In which case, your blood will be tested frequently to see if the MRTCs return.
6) Bob was close on his numbers, but these are the actual numbers for epitopes.
Tovaxin is based on T-cell reactivity to peptides from the 3 major myelin proteins, Myelin Basic Protein (MBP), Proteolipid Protein (PLP), and Myelin Oligodendrocyte Glycoprotein (MOG). Opexa uses peptides from the myelin proteins to identify the MRTCs. These peptides are used to screen for reactive T-cells found in the blood. Of the 163 peptides from these three proteins, 109 peptides have been found to be beneficial in the screening assay used in qualifying subjects for the current Tovaxin clinical trials. There were only 6 peptides from 2 of the proteins used when I started the study.
I am waiting to see posts from people who are starting the treatments in the extension study. They should keep in mind that there is a buildup period where each successive dose of vaccine stimulates the body to produce more T-cells to eliminate the MRTCs. Each injection also stimulates the immune system to produce memory WBC that continue producing the T-cells that remove the MRTCs as the body mistakenly produces them. You will start building protection with the first injection, but it may take 3 injections to get your immune system up to a level that can handle any large output of MRTCs, an attack. http://www.thisisms.com/ftopict-4868.html