Tcelna Trial for SPMS

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Tcelna Trial for SPMS

Postby xpsychiatricmd » Wed Oct 31, 2012 1:42 pm

Hello all. I am new to this forum. I was diagnosed with MS in 1999, and was able to work as a physician until last year. (Irony of Ironies...physician heal thyself!). I am looking to see whether I am a candidate to get on the Tcelna trial. Has anyone here already been selected? It is a double blind study, so what happens to those that end up in the placebo control group? In some studies, the placebo group can gain access to the drug if there is overwhelming evidence that it is helpful. This would usually occur at the conclusion of the study. In any event, it may be helpful to get other people's views.
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Re: Tcelna Trial for SPMS

Postby ssmme » Wed Oct 31, 2012 5:39 pm

Hi Xps,

I was in the phase IIB trial for Tovaxin. I received the placebo during the duration. After the trial was complete I received three injections of the actual drug. I did not realize any direct benefit. This could be because funding dried up and all study participants were let go. I did not get to complete the full set of injections.

I have to say, though, I had no side effects once I received the real thing.

I still wonder if the full set of vaccines would have helped me.

Please post and let us know if you participate in the trial.
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Re: Tcelna Trial for SPMS

Postby NHE » Thu Nov 01, 2012 2:48 am

xpsychiatricmd wrote:Hello all. I am new to this forum. I was diagnosed with MS in 1999, and was able to work as a physician until last year. (Irony of Ironies...physician heal thyself!). I am looking to see whether I am a candidate to get on the Tcelna trial. Has anyone here already been selected? It is a double blind study, so what happens to those that end up in the placebo control group? In some studies, the placebo group can gain access to the drug if there is overwhelming evidence that it is helpful. This would usually occur at the conclusion of the study. In any event, it may be helpful to get other people's views.


Your questions should be answered by contacting one of the sites participating in the trials.

You can learn more about the study protocol from their clinicaltrials.gov page.
http://www.clinicaltrials.gov/ct2/show/NCT01684761

I'm sure that others would be interested in the answers to your questions so it would be great if you could post them once you find out.


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Re: Tcelna Trial for SPMS

Postby xpsychiatricmd » Thu Nov 01, 2012 7:09 am

I will keep the forum updated whether I am selected and any changes that could arise from the trial. Thanks to ssmme for the feedback.
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Re: Tcelna Trial for SPMS

Postby xpsychiatricmd » Wed Dec 12, 2012 2:46 pm

I was selected for the Abili-T trial for Tcelna. Next Monday, I will go to the blood bank for the initial 5cc blood collection. Keeping my fingers crossed for the real Tcelna instead of the placebo.
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Re: Tcelna Trial for SPMS

Postby xpsychiatricmd » Fri Feb 01, 2013 2:29 pm

Hello all,
I received my first Tcelna/placebo vaccination today. I don't know if I received the real thing or not, but I have few comments. Like some people who tried the Tovaxin/placebo trial commented , things didn't go smooth. It turns out that the Tcelna/placebo was not shipped on time but we find out 2 hours after the neuro evaluation is completed. The reason was bad weather. It was rushed for the next day and we had to return to the center to get the product. I was told that if I couldn't make it the next by a certain time, they could ship another vaccine in 4 days. (Two weekend days included). I was able to be there today by the cutoff time (Thanks to my wife who drove me). When they are ready to inject me, I notice two syringes with a clear transparent liquid (like water or saline). After injection, the area is NOT red, without bumps, induration or pain. No side effects either. Does anybody that tried Tovaxin would venture some comments as to whether I received placebo or the real thing?. The fact that they were willing to send me another shipment, in 4 days counting a weekend if I could't be there today, made me wonder! I understand is too early to reach an appropiate conclusion. I will continue reporting and note of any changes.
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Re: Tcelna Trial for SPMS

Postby NHE » Sat Feb 02, 2013 12:48 am

xpsychiatricmd wrote:When they are ready to inject me, I notice two syringes with a clear transparent liquid (like water or saline). After injection, the area is NOT red, without bumps, induration or pain. No side effects either. Does anybody that tried Tovaxin would venture some comments as to whether I received placebo or the real thing?


Thanks for sharing you experience in the Tcelna trial. You might be interested in reading about other's experiences in Opexa's earlier trial which are likely in the Tovaxin forum. If you can't find them, then you can always try a search. I seem to remember at least one or two members discussing the injections.

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Re: Tcelna Trial for SPMS

Postby NHE » Mon Feb 04, 2013 4:21 am

NHE wrote:Thanks for sharing you experience in the Tcelna trial. You might be interested in reading about other's experiences in Opexa's earlier trial which are likely in the Tovaxin forum. If you can't find them, then you can always try a search. I seem to remember at least one or two members discussing the injections.


Their prior study results were released in Sept 2008. The day they were released the stock price fell from $2.25 to $0.25. This might have been an over reaction. There was a 37% reduction in new lesions (about the same as Ifn-beta) which was the study's primary endpoint. However, due to the experimental design of the study, it failed to reach statistical significance.
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Re: Tcelna Trial for SPMS

Postby xpsychiatricmd » Wed Feb 06, 2013 7:14 am

Hello all,
I am on my fifth day post vaccine. Not much to report. I didn't expected otherwise. Visited my internist 3 days post vaccine and I wasn't using my cane nor had the Bioness powered. Noticed that my left foot drop wasn't as bad then. My internist kept asking me why I didn't power the Bioness. I wanted to exercise the leg and see whether movements were more fluid. Too early to tell, but keeping an eye on to note any changes. Will see my regular neurologist later in the month and will ask him to help monitoring any improvement or worsening of the condition. Being a doctor myself (psychiatrist), hasn't made a difference assesing for any changes, so far. Anybody else on the Ability-T trial? It would be good to compare notes!
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Re: Tcelna Trial for SPMS

Postby JanethePain » Wed Feb 06, 2013 8:54 pm

xpsychiatricmd wrote:Hello all,
I received my first Tcelna/placebo vaccination today. I don't know if I received the real thing or not, but I have few comments. Like some people who tried the Tovaxin/placebo trial commented , things didn't go smooth. It turns out that the Tcelna/placebo was not shipped on time but we find out 2 hours after the neuro evaluation is completed. The reason was bad weather. It was rushed for the next day and we had to return to the center to get the product. I was told that if I couldn't make it the next by a certain time, they could ship another vaccine in 4 days. (Two weekend days included). I was able to be there today by the cutoff time (Thanks to my wife who drove me). When they are ready to inject me, I notice two syringes with a clear transparent liquid (like water or saline). After injection, the area is NOT red, without bumps, induration or pain. No side effects either. Does anybody that tried Tovaxin would venture some comments as to whether I received placebo or the real thing?. The fact that they were willing to send me another shipment, in 4 days counting a weekend if I could't be there today, made me wonder! I understand is too early to reach an appropiate conclusion. I will continue reporting and note of any changes.


This what I get for falling off the radar and not checking in until today! T-Celna is off and running and there are stock quote reports on Opexa's website! Yippee!!
First of all, XPsych, HUZZAH for getting IN the program and getting your first jabs! :-)
Now let's see, I have to dig back into ancient history and try to remember what was what BUT I do remember the first bunch of lab rats (me, included) wondered if we got the real juice or placebo. We'd seen a piccie of the vial of gunk posted on a website that looked like Yoohoo Chocolate cola and some of us were upset when we got clear liquid.
Not to worry, though. I got clear liquid and it WAS the real thing. :-)
Side effects? Nary a one. In fact, I think the sum total of "side effect" in OUR trial was someone having a reaction to that itty bitty round band-aid (obviously, someone had a little latex allergy).
So I don't look for any of you all to have problems, either.
What I DO expect is for you all to have positive results so we can get this stuff ON the market asap.
I "enjoyed" a two-year period of flare-free existence after our trial was suspended but this long, LONG sweep of time without has kicked me pretty hard. I have no desire to go back to those interferons. I guess that boils down to having access to Tovaxin (T-Celna for you) with improvement AND no side effects just makes thinking about the other stuff unbearable.
GOOD LUCK a thousand THOUSAND times!
I'm going to prowl through my old e-mail and message files and see if the rest of my lab rats know about this news yet.
Again, I apologize for not getting here sooner to read your exciting news and cheer you on!
Off to lasso The Old Gang and get this forum heated up again! :-)

Best,
Jane!
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Re: Tcelna Trial for SPMS

Postby xpsychiatricmd » Thu Feb 07, 2013 7:28 am

Hi Jane,
Thank you for your post, It is EXTREMELY helpful. I goes to show that a little knowledge can be dangerous. ( What do I know? ). When I received the vaccine/placebo, I peeked at the vial and noticed a clear, transparent liquid. Thinking that since the active drug could look different as it contained cells, it could look cloudy or hazy. My wife who is also a RN, told me that if a vaccine looked that way probably would be discarted. ( She now works as a psychotherapist, so she has been away from mainstream nursing for a while ). The doubt still was there, so we searched all through the internet for answers to no avail. Now thanks to you, we have an answer!!! I could still be on the placebo group but your post gives me hope. As a SPMS patient, I don't have many options left. I pray that you are holding your own with this disease.
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Re: Tcelna Trial for SPMS

Postby JanethePain » Thu Feb 07, 2013 8:59 am

Well, xpsych, that's supposed to be what we're here for (if we don't get lazy and fall off the radar for MONTHS at a time). If they paid me in Baked Cheetos, I would have been broke AND starved by now, you see! :-)

For what this is worth, I'm going to give you the run-down of how the Phase II Trials went for us... it could be interesting to see how YOUR trials go (what changes Opexa made between ours and yours) and maybe guess the "why" behind the changes... if they exist.

So here goes:

I participated in the Phase II trial in Columbus, Ohio... which is about a 90 minute drive from Home Sweet Home just north of Cincinnati. A little nerve-wracking in winter but I was very lucky.

Even before our trial began, we had to make sure we were steroid-free for 60 days and antibiotic-free for 30 days. Some of us had some major anxiety during sinus infection season, I'm here to tell you. Sheesh! Now at the time, we really didn't know Restasis (that dry-eye medicine) fell outside those parameters (it's an anti-inflammatory), but since we didn't know for sure, my eye doc suggested being safe rather than being excluded from the trial, so I had some VERY dry eyes for the duration of my trial.

So here's how "Shot Day" went for me:

1 light breakfast and fill up my HELLO KITTY cup with cranberry juice and slurp, slurp, slurp all the way to Columbus. :-)
2 Irene the hematologist knew my schedule before long and had the sterile specimen cup for the urine sample ready to hand me as I flew from her door to the ladies' room. :-)
3 Turn in the urine sample and off to put on my Hannibal Lecter mask and get the MRI (with and without contrast).
4 Back to see Irene who was as ready to play Draculette and drain about 55 gallons of my blood to keep an eye on those MRTCs and check for all sorts of other little exciting things. ;-)
5 Off to see the coordinator of the trial so we could do the Cognitive Function test. This involved listening to a guy who sounded EXACTLY like HAL9000 asking some math questions that drove me nuts. Math was never my strong suit, anyway, and there were times I was ready to put the cassette recorder and Hal in the Sharps Container and be done with 'em. Just kidding. But Hal was very annoying.
6 Short timed walk. Now here's where OUR trial and YOUR trial will probably differ since part of our inclusion criteria was to be ambulatory.
7 Long walk for endurance testing. No problem here for me except I always forgot how many times I had left to go up and down that loooooong corridor. :-)
8 About twenty minutes with the neurologist. This guy was great--in fact, there was a definite positive vibe about that entire practice (very unlike the two practices within Cincinnati where I was treated before I fired 'em all and decided to go without treatment). ***IF*** this good stuff EVER gets to market, I'm seriously considering going up to Columbus for my treatments. THAT'S how terrific they were.
9 Time for the Nurse Practitioner to give me the good stuff. First of all, she drew a big circle on each arm with a blue magic marker. Outside the circles, she wrote in the date. First jab... add the time. Pull out the handy-dandy digital camera and take a picture. Take more pictures after 30 minutes and after one hour. Cover with an itty bitty Band-Aid "spot."
As the gang up in Columbus got to know me, they started scheduling me for appointments when drug reps would visit the entire practice. They timed these appointments so I would just be finishing up about the time the "complimentary lunches" would arrive that would, I have no doubt, have fed the 5000. :-)
Back home.
11 The next day, the nurse practitioner would call and ask the status on the injection sites. I never had a reaction. EVER.
And the very last MRI I had during that trial had my neuro so elated he told me that he couldn't ask for better results. I took that as THE best approval for our medicine.

So... how do we compare? :-)
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Re: Tcelna Trial for SPMS

Postby xpsychiatricmd » Thu Feb 07, 2013 1:05 pm

Hi Jane, Thanks again. I too went through similar steps. The first evaluation was to review the records and obtain a baseline neurological evaluation. I saw the neurologist involved in the study at the center i and another one who actually gathered the History and performed the Physical Evaluation. From there I was scheduled another day to give the blood at the bank. I don't have good veins, so I made sure that I hydrated well 24-48 hours before the procurement. Anxiety, was on crecendo when the phlebotomist told me that he had ONE SHOT to get the vein! Things went well however, as he got a vein with no difficulty. I don't know whether he was teasing me or not! Next, on yet another day, I went for my MRI. I had problems getting there since it is located in a relatively new area and Mapquest took me to the wrong address. I had to re-schedule. Now we were in a time crunch because the MRI needed to be done at least two weeks before the first Tcelna/placebo vaccine. Well, the next time I brought my wife along so she could assist me finding the place. We had no problems. Then during the MRI, due to all the water I took to ensure that they could find a vein, nature called! We had to be VERY STILL for the pictures and somehow for the grace of God, they were able to assist me with the plastic container! Needless to say I was a bit embarrassed. The next step was the actual injection after another neuro eval, and neuropsych screening.( Like you, I had to listen to Hal) , add numbers (I felt very stupid) and put the pegs in the holes. Then, I had to walk 200 feet without the assistance of a cane. When we were ready for the injection, we find out that due to weather in Texas, the Tcelna/placebo was not shipped as expected. We need to return to the center the next day by a certain time so that the specimen is not damaged. (If there was a therapeutic speciment). Luckily, since we live an hour from the center, we were able to make it on time. So, the process was rather obtuse but at the end successful.
Jose-Rafael
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Re: Tcelna Trial for SPMS

Postby xpsychiatricmd » Fri Feb 08, 2013 5:11 pm

Still wondering whether the color of the Tcelna vial differs from the placebo. In a review of the Tovaxin extension study, Marcia (ssmme) posted that the vial looked murky, cloudy. On the IIb trial in which she received placebo, the vial was transparent. Would appreciate if more people comment on their experience regarding the appearance of the vaccine. I am not ready to leave the trial and intent to go through the first 100 days before any changes. Having said that, my MS is not dormant and I need to make careful choices.
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Re: Tcelna Trial for SPMS

Postby xpsychiatricmd » Fri Mar 01, 2013 5:04 pm

Hi all,
Got my second dose of the Tcelna/placebo today. It appeared a bit cloudy perhaps because the vial was cold. So far I have not seen a big change but will continue to monitor.
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