News on the Tovaxin Extension Trials

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News on the Tovaxin Extension Trials

Postby NHE » Sun Jun 24, 2007 4:10 pm

Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin™ for Multiple Sclerosis
June 21, 2007 09:19 AM Eastern Daylight Time

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Effectiveness Shown in Relapsing Remitting Subjects Across Both Phase I/II Dose Escalation and Extension Trials

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced positive top-line data in an open-label Phase I/II extension clinical trial of the investigational T-cell vaccine, Tovaxin™, for multiple sclerosis (MS). In this one-year, 8-subject extension clinical trial of relapsing remitting (RRMS) and secondary progressive (SPMS) subjects, Tovaxin therapy was shown to be safe and effective. The "per-protocol" analysis of Tovaxin therapy achieved a 92% reduction in annualized relapse rate (ARR) in subjects who received two treatment doses of 30 – 45 x 106 attenuated T-cells eight weeks apart and were monitored for an additional 44 weeks. Subjects in the extension study had previously been treated an average of 5.2±1.8 (1, 8; median 5.4) years earlier at Baylor College of Medicine under the direction of Jingwu Zhang, M.D., Ph.D with a T-cell vaccine developed from myelin basic protein (MBP) reactive T-cells. The safety profile revealed only injection site mild reactions and no severe adverse reactions related to T-cell vaccination.

Both Phase I/II clinical studies have demonstrated that T-cell vaccination depletes myelin reactive T-cells in peripheral blood. In the extension study patient population, the myelin reactive T-cell frequencies were reduced by 84% and 72% at 6 and 12 months on study, respectively. Reductions in myelin reactive T-cell frequencies in the dose escalation study were 76.7% and 64.8% at 6 and 12 months on study, respectively.

All subjects currently are enrolled in a retreatment extension study to collect longitudinal safety and effectiveness data.

Effectiveness data for the 13 RRMS subjects across the two Phase I/II trials showed an 80% reduction in ARR. The Expanded Disability Scoring Scale (EDSS) for the RRMS subjects for a 0.5 point effect was improved, unchanged and worsened by 64.3%, 21.4% and 14.3%, respectively. The EDSS for a 0.5 point sustained (no change over 3 months) effect was improved, unchanged and worsened by 42.9%, 42.9% and 14.2%, respectively. The EDSS for a 1.0 sustained effect was improved, unchanged and worsened by 28.6%, 57.1% and 14.3%, respectively.

Brian Loftus, M.D. of Bellaire Neurology, the Principal Investigator of these Tovaxin studies, commented, “This data, combined with prior data presented on myelin reactive T-cell frequencies and ARR reductions, laid the ground work for the placebo-controlled Tovaxin IIb clinical trial (TERMS). We have shown that myelin reactive T-cells can be identified and used to produce T-cell vaccine which effectively induces the depletion of an individual’s autoreactive T-cells and results in positive clinical outcomes. I anticipate Tovaxin will usher in the age of personalized therapy for MS.”

David McWilliams, president and chief executive officer of Opexa, said, "We are particularly encouraged by the data from this extension trial which indicates that subjects previously treated with T-cell vaccine can be safely and effectively retreated with Tovaxin. This outcome is important to our planned extension trial for subjects currently enrolled in our TERMS trial following the one year core study time period.” In addition, the effectiveness data in RRMS subjects across the two Phase I/II trials indicate strongly positive outcomes in both ARR and EDSS improvements following Tovaxin therapy.”
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Postby robbie » Mon Jun 25, 2007 7:15 am

Effectiveness data for the 13 RRMS subjects across the two Phase I/II trials showed an 80% reduction in ARR. The Expanded Disability Scoring Scale (EDSS) for the RRMS subjects for a 0.5 point effect was improved, unchanged and worsened by 64.3%, 21.4% and 14.3%, respectively. The EDSS for a 0.5 point sustained (no change over 3 months) effect was improved, unchanged and worsened by 42.9%, 42.9% and 14.2%, respectively. The EDSS for a 1.0 sustained effect was improved, unchanged and worsened by 28.6%, 57.1% and 14.3%, respectively.

What does this mean ? EDSS went from say 4 too 2 or 6 too 3 what does this mean? Who reads this stuff, it must be other doctors and scientists because it can't be meant for the average person..
Had ms for over 19 years now.
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Postby Lyon » Mon Jun 25, 2007 9:51 am

Hi robbie,
These press releases aren't nearly as informative as something like a journal article. Other than investors I'm not sure who they're written for because researchers pay them no heed and they are kind of hard to understand for a layman.

First, the way it reads it involves an extension trial of 8 people who had been originally treated at Baylor. I don't know if that includes Tim's group or not because, although he gets treatment in Houston, both Opexa and Baylor are in that area and I was under the impression that he had always dealt with Opexa.

For my purposes, it doesn't seem that this release is worth much because it talks about reducing annual relapse rate and it talks of improved, sustained and worsened EDSS but it doesn't mention baselines upon entrance or at the end of the extension study and since these people were treated earlier it doesn't mention if they had all been treated continously, or if there was a lapse and it's not clear if the comparison is against their original entrance or entrance into the extension.

In other words, it's kind of like a postcard from Texas saying "things are going great! Wish you were here!" but we can only take their word for it.
Bob
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Re: News on the Tovaxin Extension Trials

Postby NHE » Mon Jun 25, 2007 12:45 pm

robbie wrote: What does this mean ? EDSS went from say 4 too 2 or 6 too 3 what does this mean? Who reads this stuff, it must be other doctors and scientists because it can't be meant for the average person..

Hi Robbie,
The quote that you pulled out of the press release seems to be saying that most people in the extension trials either improved in their EDSS or had no change while a few may have actually worsened.

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Postby robbie » Mon Jun 25, 2007 12:54 pm

Thx Bob and NHE...
Had ms for over 19 years now.
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