dose escalation results

A board to discuss Tcelna as a treatment for Multiple Sclerosis

dose escalation results

Postby sh8un » Tue Apr 03, 2007 8:30 am

April 03, 2007 07:00 AM Eastern Daylight Time
Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Dose Escalation Trial with TovaxinTM for Multiple Sclerosis
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 dose escalation clinical trial of the investigational T-cell vaccine, Tovaxin™, for multiple sclerosis. In this one-year, 10-subject dose escalation clinical trial, Tovaxin therapy was shown to be safe and effective. The “per-protocol” analysis of Tovaxin therapy achieved a 90% reduction (p = 0.0039) in annualized relapse rate (ARR) in subjects who received one of the three dosage levels; the doses were 6 – 9 x 10^6, 30 – 45 x 10^6 or 60 – 90 x 10^6 attenuated T-cells. Subjects in the study received subcutaneous injections of Tovaxin over a period of 20 weeks (0, 4, 12 and 20 weeks) and were monitored for an additional 32 weeks.

The safety profile for all dosage levels revealed no severe adverse reactions related to T-cell vaccination. With increasing dosage, an increase in mild injection site reactions was observed and these resolved within 48 hours.

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

David McWilliams, president and chief executive officer of Opexa, commented, “We are particularly encouraged by the data from this dose escalation trial. While all three dosage levels were safe and effective, the group treated with the 30 – 45 x 10^6 T-cell dose achieved a 100% reduction in ARR. The currently enrolling Tovaxin IIb clinical trial is being conducted with the 30 – 45 x 10^6 T-cell dose.”

About TERMS

The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T- cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate. As of March 19, 2007, Opexa reported that more than 110 patients have been enrolled in the TERMS clinical trial and the Company expects enrollment to be complete by mid 2007.

All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

The TERMS study is being conducted at 36 U.S. sites to evaluate the safety and effectiveness of Tovaxin It is registered on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions. For more information, visit the TERMS website at www.tovaxin.com.

About T-cell Vaccination

For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin™. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients.

About Opexa Therapeutics

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product, Tovaxin(TM), a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Editor's Note:

In first and fourth paragraphs of this release, T-cell dosage levels include the figure 10(6), which
sh8un
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Postby Lyon » Tue Apr 03, 2007 9:51 am

Thanks sh8un,
After you brought that to attention I wanted to bookmark the actual article and here is a link http://tinyurl.com/2a4ah9

This probably isn't the correct time and place but months ago you mentioned that you might be moving to California. Did you?
Bob
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Postby sh8un » Tue Apr 03, 2007 10:36 am

Hi Bob,
I have not moved yet. I am still in the process. The board of nursing in Cali had said that I was missing some courses which I was not. They are also very slow in processing my application. I am still going to though.
Isn't the Tovaxin news exciting????
I am very happy about more positive results.
NN
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Postby Lyon » Tue Apr 03, 2007 11:20 am

Hi NN,
That's good, it sounds like the job and move is still going to happen, just going slower than expected.

I do find that Tovaxin news exciting. Going from my notoriously bad memory it seems that Tim has mentioned, those results were using three peptide strains as opposed to somewhere around a hundred from the current IIb trial, although it's going to be hard to find much better results than they've already seen.

The info isn't available yet but hopefully some of this is also improving the odds of finding the necessary mrtc's in a higher percentage of registrants.

Thanks for posting that. I wouldn't have seen it otherwise.

Bob
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The word "peptide"

Postby lyndacarol » Tue Apr 03, 2007 2:12 pm

Lyon, you know me and my insulin obsession.

I just have to pop in after your comment,
using three peptide strains
and tell you that insulin is a pancreatic polypeptide hormone. Now, being a nonscientist, I can't tell you what that is; but the word similarity is interesting, don't you think? Anyway, it made me think of insulin--as everything does!!!
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Postby Lyon » Tue Apr 03, 2007 3:14 pm

Hi Lynda,
I'm beginning to think this is your way of saying "hi" occasionally :lol:

To be honest, this whole peptide thing is out of my league and I don't understand the similarities, but there evidently is some kind of link between anything using the word "peptide" http://en.wikipedia.org/wiki/Peptide

I admit that you find a lot of things pertaining to MS and insulin, but because these diseases which are considered "autoimmune" share unknown but very strong commonalities, I would expect those kind of things.

My gut feeling is that you would find just as many pertinent relationships if you were the Thyroid girl or the Crohn's girl or the Rheumatoid arthritis girl. I don't disagree with the points you make, I just feel they are caused by the disease process and not the cause of the disease process.

Nonetheless, one of these days I'm going to agree with you just to freak you out......not today though :twisted:

Bob
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Postby Loobie » Wed Apr 04, 2007 4:47 am

Hell yes this is good news!
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numbers

Postby Kimscupoftea » Wed Apr 04, 2007 5:46 pm

Can someone compare what the 90% number means with a similar number for one of the CRABs? I'm just trying to understand it as to what it means relative to something we are more familiar with. napay
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Postby Lyon » Wed Apr 04, 2007 9:32 pm

Good question napay,
I myself have never completely understood what the claimed efficiencies encompass myself but I think it generally refers to the annual relapse rate....without a doubt this latest Tovaxin release refers to that and in checking the crabs on the NMSS website I see they also refer to ARR.

That seems to mean that you should be comparing the claimed 100% reduction in relapses with Tovaxin to the claimed 30% or so of the crabs and from what I've been able to tell, about 50% Tysabri mono therapy.

After that point I think it's up to each of us to make what we will of the available information. I've never been able to determine that the researchers know the mode of action with any certainty regarding the crabs. Whatever it is that they do, they obviously don't do it very well.

Tovaxin removes the myelin reactive T cells. That's all it does and it seems to do it very well. Time provides the necessary evidence but time seems to be showing that removing the myelin reactive T cells is confronting the MS process at an early enough point that it stops any forward motion of the MS mechanism that we are familiar with....inflammation, lesions, myelin loss, axon loss, brain atrophy.

It might be overly optomistic on my part but it seems to me that in the case of Tovaxin 100% reduction in ARR might also equate to 100% reduction of progress in every other aspect of what we consider early MS.

Bob
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Postby connieb » Thu Apr 05, 2007 8:25 pm

Here again my concern in interpreting these results would be the whole confusing issue of the percentage of subjects in whom they've successfully isolated MRTCs for the vaccine-- in other words, 90 to 100% reduction is much less impressive if they are only able to make this vaccine for 40% of the people with MS. Sure hope that's not the case and that it's 100% out of 100%!
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Postby Lyon » Thu Apr 05, 2007 9:29 pm

connieb wrote:Here again my concern in interpreting these results would be the whole confusing issue of the percentage of subjects in whom they've successfully isolated MRTCs for the vaccine
Hi Connie,
I think the situation is certainly what you mentioned....wonderful news for someone who produces the necessary mrtc's.

For everyone else, cause for hope that Opexa finds ways to widen the base of people they can treat? I see your point, it's not completely accurate to flatly call it 100% effective and let it go at that.

Bob
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