TOVAXIN ROLE CALL

IHaveMS-com · Post by **IHaveMS-com** » Fri Jun 01, 2007 7:39 pm

The scientists believe that they can make vaccine for 95% of people with MS. In this study they feel that 50% will test positive for MRTCs. There seems to be 45% missing somewhere.

Lyon · Post by **Lyon** » Fri Jun 01, 2007 7:59 pm

IHaveMS-com wrote:The scientists believe that they can make vaccine for 95% of people with MS. In this study they feel that 50% will test positive for MRTCs. There seems to be 45% missing somewhere.

Hi Tim,
I'm not sure this is exactly what the scientists are referring to with the 95% figure but if the mid dose of Tovaxin continues to prove close to 100% effective with no side effects, compared to use of the crabs it seems that even the people with slow growing mrtc's would be better off accepting dosing with Tovaxin at whatever rate Opexa can make it.

Even if it's only every 6 months. The "whenever it's ready" dosing strategy might account for the missing 45%-maybe?
Bob

robbie · Post by **robbie** » Sat Jun 02, 2007 4:51 am

100% effective

Bob when they use these kind of numbers does this mean they have found a cure ?

Lyon · Post by **Lyon** » Sat Jun 02, 2007 5:58 am

robbie wrote:
100% effective
Bob when they use these kind of numbers does this mean they have found a cure ?

Hi robbie,
That's a little deceptive and I should watch what I say. Sorry!

It's important to keep in mind that at this point Opexa can only create the Tovaxin vaccine for around 50% of the RRMS patients who registered for the clinical trial so in essence the situation was that it was effective 100% of the time (in the 35-40 million cell mid-dose phase of the I/II) on the 50% of the people who made it into the trial.

I'm very, very hopeful for Tovaxin, but it's not what most people would consider a "cure" for several reasons.....at least not at this point.

Bob

IHaveMS-com · Post by **IHaveMS-com** » Sat Jun 02, 2007 6:21 am

Hi Bob,

Shouldn't you be getting ready for your party? I been working on a reply for Robbie's question.

Opexa hopes to be 100% effective, but the interim data from my study showed 92% efficacy.

I will be back shortly, and you should go attend to your guests. I have this vision that you will be sneaking back in to look at your computer every chance you get. Enjoy the day, but you will need to keep an eye to the sky.

IHaveMS-com · Post by **IHaveMS-com** » Sat Jun 02, 2007 6:38 am

Hi Robbie,

if the mid dose of Tovaxin continues to prove close to 100% effective ...
when they use these kind of numbers does this mean they have found a cure ?

The hope for Tovaxin is that it will stop the attacks. It works by stimulating the immune system to produce memory white blood cells (WBCs) programmed to produce T-cells that eliminate MRTCs. There are only 1 or 2 per 1 million T-cells that are MRTCs, so their removal does not compromise the immune system. If the level of protection can be kept sufficiently high, then the number of MRTCs can be kept at or close to zero.

It is believed that something triggered the body to produce memory WBCs, which produce MRTCs that destroy myelin. These bad memory WBCs remain in the body and continue to produce MRTCs. A cure would be to eliminate them. But even that would not be a true cure, because the immune system could be triggered again sometime in the future.

Tovaxin causes the body to produce memory WBCs that produce T-cells that destroy the MRTCs as they are produced. It takes approximately 3 treatments of Tovaxin to bring the level of protection up to the point where the MRTCs are kept at or near zero.

Everyone is going to build protection against MRTCs differently. Everyone is going to have a different rate at which they produce MRTCs. By monitoring a patient's blood, the amount of Tovaxin needed to keep the MRTCs at or near zero can be determined and the appropriate dose and cycle of vaccine can be determined.

I assume that during the build up period, while there is still MRTCs floating around, a patient could have an attack, but once there are no more MRTCs, the attacks should stop.

Two people who were in Dr. Zhang's T-cell vaccine study at Baylor in the late 1990s no longer produce MRTCs. They will still need to be monitored, but at this point they at remission.

I hope that in the future, patients who are on Tovaxin and no longer having attacks, will consider they are cured of MS. A true cure will not be eliminating the MRTCs or the memory WBCs that produce them, but removing the mechanism by which the immune system is triggered to produce MRTCs.

IHaveMS-com · Post by **IHaveMS-com** » Sat Jun 02, 2007 6:44 am

Opexa hopes to be 100% effective, but the interim data from my study showed 92% efficacy.

I forgot to add that the vaccine used for my study used 6 peptides to identify MRTCs. The current vaccine uses about 100 peptides. The increased number of peptides should identify more and maybe all of the MRTCs.

Lars · Post by **Lars** » Sat Jun 02, 2007 7:21 am

Bob has a party and Tim can't seem to stay away from us no matter how hard he tries. I for one am glad you both work so hard, thanks. Now take a day off! Upon your return, what is the dosing in the phase II/b trial compared to the 35-40 mil. in the phase II trial? I know that this has already been covered somewhere but I guess I took a day off. Have a great weekend.
Lars

Lyon · Post by **Lyon** » Sat Jun 02, 2007 7:27 am

IHaveMS-com wrote: Shouldn't you be getting ready for your party?

Hi Tim,
I wrote that reply to robbie and picked up 16 helium filled "HAPPY GRADUATION!!" balloons on an 80-some degree day in a mustang convertible with which the air conditioning doesn't work. The 20 miles home with the roof and windows closed in a car full of balloons and me was a memorable experience!

On one of these computers I have a link to a page on the Opexa site, which I'm sure said that the mid dose was 100%. I'll post a link when this circus is over.

More of a mystery than, perhaps even MS, is why people come to "help" prepare for a graduation party and bring their uncaged little kids.

Bob

IHaveMS-com · Post by **IHaveMS-com** » Sat Jun 02, 2007 7:33 am

Hi Bob,

On one of these computers I have a link to a page on the Opexa site, which I'm sure said that the mid dose was 100%.

I think this refers to 100% reduction in MRTCs.

Lyon · Post by **Lyon** » Sat Jun 02, 2007 8:00 am

IHaveMS-com wrote:Hi Bob,

On one of these computers I have a link to a page on the Opexa site, which I'm sure said that the mid dose was 100%.
I think this refers to 100% reduction in MRTCs.

You're right and this might be one of those situations in which a little verbal slip makes a big difference....or does it? I thought part of what Tovaxin was demonstrating was that reduction in myelin reacting T cells is synonymous with the end of disease progression?

NOW I'm heading out the door to the party.

Bob

robbie · Post by **robbie** » Sat Jun 02, 2007 8:04 am

Hi, so for the people that Opexa can create a vaccine for it is 100% affective, so it is basicly a cure for 1 out of 2 people right now, thats pretty good. This number will only get better i hope. What i am not sure about is if SPMS is basicly having a relapse all the time(mild or severe) then why won't all these drugs that seem to stop relapses work on us SPMSer's and PPMSer's.

IHaveMS-com · Post by **IHaveMS-com** » Sat Jun 02, 2007 8:12 am

Hi Lars,

I have a bad habits of jumping in at the last post and not looking at the posts above it. I almost didn't see yours. Thank you for your words of support. It is hot and humid here today, so I probably will be on and off the computer all day.

The mid-dose in my trial I/II, the extension study, and the current IIb are all the same at 30 to 45 million cells. The frequency in my trial was 4 treatments and then reassess in 7 months. At which time they would draw more blood for the next round of vaccine.

The extension study and the IIb study are similar, but not the same. Each receive 5 treatments. The IIb study receives injections at weeks 0, 4, 8, 12, and 24. My 5 treatment are given 8 weeks apart, weeks 0, 8, 16, 24, and 32.

Since the protocol is not yet set for the extension study for the current IIb participants, I think it is reasonable to assume the dose will be 30 to 45 million cells, there will be 5 treatments, but the spacing of the treatment may be different than mine.

IHaveMS-com · Post by **IHaveMS-com** » Sat Jun 02, 2007 8:32 am

Hi Robbie,

so for the people that Opexa can create a vaccine for it is 100% affective

No, it removes 100% of the MRTCs. If there is no other mechanism at work in MS, then 100% reduction in MRTCs would equate to 100% effective.

What i am not sure about is if SPMS is basically having a relapse all the time(mild or severe) then why won't all these drugs that seem to stop relapses work on us SPMSer's and PPMSer's.

My study had both RRMS and SPMS. I have not seen anything that breaks the data into RRMS and SPMS. Since the report stated that all patients saw a decrease in their EDSS and at the mid-dose, all patients had a 100% reduction in their MRTCs, it is no great leap to assume this will work for SPMS also.

As for PPMS, the company had originally planned to do a study of Tovaxin on PPMS because there wasn't anything approved for use against it. You can conjecture that they think it will work for PPMS. The company's focus is currently on RRMS and CIS, but I assume they will go after SPMS, PPMS, and PRMS in the future.

robbie · Post by **robbie** » Sat Jun 02, 2007 8:47 am

No, it removes 100% of the MRTCs. If there is no other mechanism at work in MS, then 100% reduction in MRTCs would equate to 100% effective

So what this means is if their is no other mechanism that causes ms other than MRTC's and tovaxin gets rid of them all then it's a cure for 50% and they just need to figure out the other 50%.

My study had both RRMS and SPMS. I have not seen anything that breaks the data into RRMS and SPMS. Since the report stated that all patients saw a decrease in their EDSS and at the mid-dose, all patients had a 100% reduction in their MRTCs, it is no great leap to assume this will work for SPMS also

So does this mean that there are people in the trial with SPMS and they two have seen good things, MRTC's wiped out and a reduction in EDSS, If all my MRTS's were wiped out would i feel better?
When you say breaks in the data into RRMS and SPMS what does this mean?