Hi to all and congratulations to Lew,
It is super to see Lew moving in a positive direction. Reading about his decline and his commitment to hang in there so that he could get the “real stuff”, was gut wrenching. You can see that it took 3 treatments before the level of immunization was sufficient to allow the body to start repairing some things. As Lew pointed out, two weeks ago, he could have done only about ¼ of what he is doing now.
It is likely that there may be someone in the study who will need 4 treatments plus 10 days before things start to turn around. My protocol say that at the end of the series of treatments, if the patient is still producing MRTCs, the physician can request that more vaccine be made. If your clinic is running several studies, the physician doesn’t remember the fine points of the protocol. It is up to you to point out anything in the protocol that might be of benefit to you.
Since Lew has been kind enough to share the empirical data on his study of micturition, I will use the bladder as an example of what people in the study should be aware of. For the sake of this example, lets say that there are 10 nerves that control the urge to go (piss, pee, drain the main vein, drain the lizard, water the lawn, put out a fire, or as I like to say piddle). Since there is always a few spare nerves, lets assume that 6 is the threshold before you notice some loss of function.
Now, lets assume that a person with MS has had 5 of the 10 nerves demyelinated and is now experiencing some loss of control. If Tovaxin has stopped the attacks, and the body remyelinates 1 of the 5 that were damaged, the lost function will return. Since the repaired nerve is probably not myelinated as well as when it was new from the factory, we should expect a few short circuits from time to time.
So if the 8 ounces drops back to 5 ounces for a week or two or maybe longer, that would be something to expect to happen to some of the repairs. If the body only partially remyelinated the 6th nerve and went on to work on something else, then that regained function is going to go on the fritz periodically. So, new rule: If I get some lost function back and I lose it again, I won’t think that I am having an attack but rather, that the body needs to do some more restoration to the nerves that control that function. Corollary to the new rule: If I get back some lost function and that restoration lasts for more than 8 weeks without interruption, it is for real. In this case, if you lose the regained function after 8 continuous weeks of having it, I would discuss that with your neurologist. The real bottom line here is that if you regain some lost function and you lose it again, but you are not getting worse, then Tovaxin is working.
In my study there are patients with RRMS and SPMS. The data presented so far is that everyone at least a ½ point reduction in his or her EDSS. This would indicate that Tovaxin is likely to work on SPMS. The current study is for RRMS, and I think you need to continue to be classified as RRMS to stay in the study. I assume you understand what I am saying.
I hope that Lew continues to share personal information about his improvements as well as small rather insignificant changes. If you couldn’t peel a shrimp yesterday but you can today, that is something worth being pleased about and commenting on. I hope that Lew’s willingness to include us in his trial journey will encourage others to let us know how they are doing. Unfortunately, when you are feeling better and can be out doing things again, it is a sacrifice to sit in front of the computer and post news about how you are doing. People who are not doing well, post to try and get some answers. Silent positives will make the decision to get into the next study a much harder decision for those who have to make it.
I keep saying that I am going to leave for a while. I have been hanging around to see what Lew had to say, so maybe I can disappear for a while now.
Remember the rules:
1. It isn’t an attack unless it lasts for more than 4 days.
2. I will not consider my EDSS to have changed unless it stays changed for 2 or more consecutive assessments.
3. I will remind myself that the hope for Tovaxin is to stop the attacks. Any restoration of lost functions is up to my body.
4. I will not expect to sense any difference until at least 100 days after my first injection of the “real stuff”, and it is possible that it might take 4 treatments plus 10 days for my immunity to get up to a sufficient level to fend off attacks.
5. If I get some lost function back and I lose it again, I won’t think that I am having an attack but rather, that the body needs to do some more restoration to the nerves that control that function. But, if I get back some lost function and that restoration lasts for more than 8 weeks without interruption, it is for real, and in that case, if you lose the regained function after 8 continuous weeks of having it, discuss that with your neurologist.
6. This is a patient-specific vaccine and there are a lot of other patient-specific rules.
Best regards, Tim
In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.