Why are we keeping an eye on Tovaxin? Because Opexa seems to understand that not killing the patient is the best way to go about trying to treat Multiple Sclerosis. The only adverse effects reported in the clinical trials so far have been mild to moderate reactions at the site of injection. No one has died!
Although there was a random glitch with their trials in 2009, where the control group had a very low relapse rate and the treatment group a high relapse rate, the newest trials have been very positive:
Opexa Therapeutics announced that they are preparing to start the late-stage clinical trials for Tovaxin, a new MS drug that uses your own T-cells to make a “personalized T-cell vaccination for the treatment of MS.”
Let’s break this down into easy to understand terms about how a “personalized T-cell vaccination” would work. Taken directly from Opexa’s website is this graphic that explains the process:
No brain melt as can happen with Tysabri. No compromised immune system, bradycardia or macular edema as can happen with Gilenya. Campath, not as yet approved by the FDA, has had deaths in their clinical trials.
What remains to be seen is the cost. Will Opexa go the way Novartis did and charge $48,000 per year? (and Gilenya is a pill) or will they find a way to satisfy themselves and their shareholders and charge a reasonable fee for what looks to be a very promising therapy? Time will tell.
You can read more useful information from those who were in the Tovaxin trials here, at the This Is MS Forums.