This Is MS Multiple Sclerosis Community: Knowledge & Support

merlin26-last post at thisisms Mon May 21, 2007 11:48 pm


This was exactly my experience last spring as well.
They said that "there was a break in my cell line." Do you suppose somebody forgot to close the door on the refrigerator or something when they left for the weekend?


I got into this ONLY counting on the extension, so hell yeah I'm going into it as fast as they'll get their s**t together and let me in. My year is up at the end of June.

<edited because I found their original quote in an old journal entry and forgot about the extension info.>

It sounds like all of the trial locations had their share of bugs to work out, we endured our share.

The entrants in the phase III probably won't ever realize how lucky they are when things go smoothly for them!

Bob

This one should shake up the status quo; I was due to continue my injections tomorrow Jan. 10th after a missed month (exacerbation), We in Southwest Colorado are literally snowed in, all mountain passes that are available to reach my trial site are closed. In speaking to my coordinator about all of this, I brought up the unsavory thought of waiting the 12 weeks or whatever for the extension "juice" to be ready. She told be there would be NO DELAYS, that the scheduled appointments roll seamlessly together and that vaccine would be ready and waiting for me on my monthly visit. ????????? Protocol cannot be that different from site to site. I can only hope, wonder, how much is in the capable or incapable hands of our coordinators. Whether or not this information is truly accurate, I feel a bit more at ease. Now if I could only get to my site.
Be Well,
Lars

That's good to hear, I hope it's true.

From what I've heard, the coordinators have weekly conference calls with Opexa, so maybe the miscommunication really is all on our part?

Bob

I just got back from my trial site. The extension reps had just been there and unfortunately my coordinator was mistaken. The procurement and waiting period is what Loobie indicated.
Lars

Jeez, I just hate it when Lew is right!

I forgot to mention that Lew's "69" never came up, I still think he had his leg pulled. There was one part of the conversation that sort of blindsided me, of course it makes sense it just never crossed my mind, one must product the required MRTC's just like the initial enrollment. It would really suck to have that part of the long wait missing.
Lars

Yikes! You're right!

Maybe Tim can speak to this...

After a 7 month layoff, I'd think finding those little bastards wouldn't be too hard, but since I'm one of the guys who didn't hit on the first try last time, it makes me nervous, being as that's the payoff and all.

eek.

Lars,

I swear! I wasn't kidding on the 69 days. Opexa was the one that told me this (Dr. Garces). He said that the cell culture takes 56 days and it is about a 2 week (read: 14 day) process to get it made up and shipped. Thus 56 + 14 = 69! They have seen a good groups of patients whose cell cultures are done after 35 days, so there is a possibility (if your cells cuture quickly) that you can get it done in 49 days, but I swear they told me 56 day culture + add 2 weeks to get it done and shipped.

Lew

Tim watches the site but doesn't like to post. I suppose we could goad him into posting....last time Tim went into "retirement" I think I had to call him a skinny redhead in order to get a response

I THINK Tim might have already answered this one. If you aren't doing anything which masks mrtc's, since they've isolated your mrtc's in the past, they can do it again in the future. Otherwise, if they weren't able to isolate mrtc's from someone which they had in the past, the number really would be too low to isolate and would mean that you didn't have enough mrtc's to cause progression.

Since I'm convinced that Tovaxin will stop progression, it seems that Opexa shouldn't have any problem isolating mrtc's from those people's blood.

If I don't have it right, I'm sure we'll soon be hearing from the SKINNY REDHEAD
Bob

I am not that knowledgeable on tovaxin, but if i recall correctly, they have increased the "epitopes" that they use to identify mrtc's. To me this would imply that a persons mrtc's could move to further epitopes that they are not checking for, and as such, they would not find the mrtc's, yet the patient could still progress?

Good point Cure, and I don't know the answer.

Not completely unrelated is that quite awhile ago Tim had mentioned that Opexa had "acquired" 115 epitope strains. A lot of that kind of thing can be patented now days and at the time I wondered if "acquired" meant "purchased the rights to".

If so, that would answer some questions regarding your earlier inquiry regarding why people aren't as excited about the Sheba vaccine as they are about Tovaxin......if Opexa has the rights to the most common MS epitope strains it wouldn't leave much for Sheba to work with.

That possible situation also made me consider that if epitope strains are patentable, Opexa may have the rights and availability of most epitope strains, but not the ones that Sheba has which would leave the situation in which there may be two or three vaccines, but none of them are as effective as they could be if all epitope strains were freely available.

I suppose that what you are wondering might be known by Opexa already or it certainly will be among the things they investigated in the course of the clinical trials.

Bob

I can honestly say that I had no problems at the site where I was. In fact, they bent over backwards to accommodate me. I live 450 miles away and they worked with me so I wouldn't have to spend more time than necessary.

For my last vaccine, I had a personal emergency and had to delay arriving by one day. I called the study coordinator two days beforehand and let her know that I could not be there on the day of my scheduled vaccine shot day. I had a funeral to attend for my best friend and I would not be there. I was part of the funeral proceedings and that was that.

They completely understood and called Opexa and the vaccine was good for 72 hours. So everything was moved forward 24 hours.

It has been a pleasure working with them and I hope to continue in Phase III.

I feel bad for anyone else not having a positive experience with this study. It's difficult enough having this disease, being in a double-blind study not knowing whether you are on placebo or real drug, but when you have to deal with ineffeciences in a systems, it just makes life more difficult. It does make you wonder why people volunteer for these clincial trials.

I know I did because I was literally out of options before chemo....

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

Hi Av8rgirl!

Good to see ya over here and glad to see you made it through the year!

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