SPMS Drug in Trials

[kwarendorf]

Tclena (Tovaxin) is about to start Stage 2 clinical trials. It seems to greatly slow the progression of our favorite disease in those of us with SPMS. Here are a couple of articles.

http://www.smallcapnetwork.com/A-David-Goliath-Story-Setting-Up-on-the-MS-Front-NVS-OPXA-BIIB/s/via/1789/article/view/p/mid/1/id/238/

http://fatcatwebproductions.com/the_paper/content/opexa-initiates-late-stage-clinical-study-tcelna-patients-secondary-progressive-multiple-scl

Kyle

[sllowe]

Interesting, Kyle sounds promising...

Some excerpts....

" ...Tcelna has demonstrated one of the safest side effect profiles of any marketed or development-stage MS therapy, as well as encouraging efficacy signals indicating Opexa’s therapy may have the potential to be both safe and effective for the treatment of both SPMS and RRMS patients.

"In Phase I/II studies involving SPMS patients treated with Tcelna (n=36), 80 percent of the patients treated with Tcelna showed no evidence of disease progression at 24 months (a 50% improvement, with respect to patients showing evidence of disease progression, over historical controls).

Following two years of treatment, a subset of these patients (n=10) reported no worsening of their physical or psychological condition. Additionally, in 21 years of cumulative follow up in the same SPMS patients treated with Tcelna, the annualized relapse rate for this same subset of patients was reduced significantly compared to baseline and only one patient experienced a relapse during this time.

“We return to the clinic with an enhanced manufacturing process, an optimized clinical development strategy, Fast Track designation from the FDA and the belief that Tcelna is the most promising MS treatment in development today.”

I'd have to look at the initial study where they mention "... safest side effect profiles of any marketed or development-stage MS therapy" Wonder what they compared it to?

SPMS meds notoriously understudied in comparison to RRMS through the years.

Look forward to results on this med, and what it does with the "T-cells"

[MsmsinFl]

They are currently recruiting for this trial.  Several locations.

Must be younger than 60, and discontinue other DMDs.

Here's the link for details:

http://clinicaltrials.gov/ct2/show/NCT01684761?term=opexa&rank=3

[maxthecat43]

Finally!