This Is MS Multiple Sclerosis Knowledge & Support Community

Opexa Therapeutics, Inc. a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced the initiation of a Phase IIb clinical trial of Tcelna in patients with Secondary Progressive Multiple Sclerosis (SPMS).

Several patients have already been enrolled in the study and enrollment is expected to increase rapidly as additional sites begin screening and enrolling patients in the coming weeks. Tcelna is the first ever personalized T-cell therapy for MS patients and has received Fast Track Designation from the United States Food and Drug Administration (FDA) for the treatment of SPMS. The therapy is specifically tailored to each patient’s individual disease profile and has demonstrated superior safety and encouraging indications of efficacy in previous clinical studies in MS that included the treatment of SPMS patients. There is currently only one FDA-approved treatment for SPMS but safety warnings have severely restricted its use.

The newly initiated trial, named Abili-T, is a randomized, double-blind, placebo-controlled clinical study in SPMS patients who demonstrate evidence of disease progression without associated relapses. The trial is expected to enroll 180 patients at approximately 30 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The study will assess a number of clinical endpoints to evaluate the efficacy and safety of Tcelna in patients with SPMS. The primary efficacy outcome of the trial is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate (ARR) and changes in disability as measured by EDSS and the Multiple Sclerosis Functional Composite (MSFC)....Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1312

In the interest of clarity, I'll note here (like I did on another thread) that Tcelna is actually just a renaming of Tovaxin, which has its own forum at ThisIsMS, which has also now been renamed the "Tovaxin (Tcelna)" forum in the interest of clarity and ...

Oh hell, here's the link to it so you can check it out yourselves.

http://www.thisisms.com/forum/tovaxin-f36/

Another quote from Squiffy's msrc article:

Finally, to reflect its work in optimizing the overall manufacturing process and clinical development strategy for the program, Opexa’s lead product candidate, formerly known as Tovaxin, has been rebranded as Tcelna.

Opps, sorry

squiffy2 wrote:Opps, sorry

That's okay, squiffy, they intentionally buried that little tidbit of info at the very end of their major announcement to confuse us all. I was just thinking...if the companies could just change the name of their drugs now and then after they've been on the market they could gather a whole new clientele from patients (AND doctors) who assume they're seeing a brand new drug!

I'm sure that's the reason they change the names anyway once they're close to market - in order to remove anyone's memories of the problems & glitches they encountered during trials. And then they can come out with entirely new explanations for the press that aren't tainted with the limitations and/or failures demonstrated in the early reports.

And...if they could achieve the same market effect from a new name, they wouldn't have to bother tweaking their meds into a slightly different version to get a new patent on basically the same thing like they do now. Don't worry, Squiffy, we'll be getting threads posted about the NEW drug Tcelna here for weeks!

And welcome to our established world of MS medicine!!! They've been doing this for years.

Harry