Hi to all,
There were 2 interesting facts, at least to me, which were in the latest press release about my study. http://tinyurl.com/6f7f36
The first one was a break down of the study participants into RRMS and SPMS. I could tell from previous data that Tovaxin must work for SPMS, but this report shows that 41% of the study participants had SPMS. Without breaking the study population into RRMS and SPMS, one can only speculate how beneficial Tovaxin is in treating SPMS.
The “intent to treat” population of 22 patients included 13 with relapsing remitting multiple sclerosis (RRMS) and nine with secondary progressive multiple sclerosis (SPMS). An analysis of disease progression of disability over a two year period, as measured by a 1.0 or greater change in Expanded Disability Scoring Scale (EDSS), showed that 27.3% of patients demonstrated sustained improvement, 59.1% had no disease progression and 13.6% experienced sustained worsening of disability. The improvement in the EDSS scores ranged from 1.0 to 4.5 (average 2.41). During the two-year study period 72.7% of patients remained relapse-free.
The second point was about epitope shifts. I know during the first 2 years, I did not have any epitope shifts in my set of MRTCs. Since I was only aware of what was going on with my MRTCs, I, from a sample of one, felt that epitope shifts were either unlikely or slow to occur.
I have always answered questions using my own experience or by asking those who are on the cutting edge, such as Dr. Zhang and others involved in T-Cell vaccine. So, if you are keeping score, this goes in the error column. Another error occurred when I said you could not transfer from one site to another. I have been flying to Houston for over 5 years, and will continue flying there until Tovaxin is approved. In my study you cannot transfer to another site; in the current IIb trial and extension, you can transfer to another site.
I have put my cape in the closet. If I find any other misstatements, I will be sure to point them out. If you are deciding to be a lab rat, that decision should be based on the best possible information available at that time.
“Approximately three out of four patients re-treated in the second year exhibited a change in their myelin-reactive T-cell profile, which was the basis for producing their individualized T cell vaccine,” said David McWilliams, president and chief executive officer of Opexa. “We believe this new data supports the continuation of our development strategy of individually monitoring patients with our proprietary epitope analysis assay and re-treating them with a patient-specific therapeutic vaccine that associates with their clinical status.”