Tovaxin Clinical Trials

[coach]

Haven't posted in a while, but found the information about Tovaxin to be interesting as well as promising. Just wanted to let the members know there will be a clinical trial of Tovaxin starting in February 2006. Information can be found at ClinicalTrials.gov. Trial number identifier is NCT00245622. This is a phase II trial. Unfortunately, my age (50) and type of MS (my neurologist just told me he would classify mine as secondary progressive, although slowly progressive) excludes me from consideration as a trial participant. What's a gal to do?

Ladelle
Psalm23

[CureOrBust]

Unfortunately, my age (50) and type of MS ... excludes me from consideration as a trial participant. What's a gal to do?

In some countries there are laws that allow people to receive un-approved treatments on compasionate grounds. I would contact the company directly to see if there is something like this available.

Good luck

[OregonMom]

I emailed Ms. Inman, the Tovaxin contact, in mid-November. I want to be included in the clinical trial. On December 5th I received this email in response:

Hi XXXX,

I will place you on the TERMS study waiting list and will notify you
when a site has been selected closer to your home in Oregon.

Thanks for contacting us.

However...I've started Rebif since I first contacted her. I think I'd still qualify for the study as long as I discontinue the Rebif for 60 days prior to starting the Tovaxin regime.

My big dilemma: if I'm accepted into the trial, would it be worth the risk IF I receive the placebo for a year and I lose the benefits of Rebif? If I understand correctly, 1/3 of the subjects will receive the placebo.

I'm leaning towards taking the risk if I'm accepted. I'm curious to know what the rest of you would do...?

[CureOrBust]

Please note, ALL of the below are just my thoughts and not from a thorough investigation.

1. rebif has an effective rate quoted at 30%. Which is slightly less than 1/3.

2. rebif from my understanding hasnt got the history of improvements that we hear people on tovaxin supposedly have reported.

3. rebif requires 3 injections per week. I am guessing the tovaxin trial will require less

4. rebif can cause many side effects while tovaxin appears to be better tollerated

Under the above assumptions, i would personnally chose the tovaxin trial over rebif. Which is suprising for me, as I would kick and scream like all h%$£ if i found out i was on placebo.

If i had ANY signs of a relapse, i would fairly quickly make noise also. Dont forget, at the end of the year, you get it for sure. But one year can be a long time in MS. It would depend on how bad my relapses were in the past.

And dont forget, you can always pull out of the trial. Even though this wont be good for the general MS public, i think you need to look after yourself first.
Just my thoughts.

[OregonMom]

Please note, ALL of the below are just my thoughts and not from a thorough investigation.

1. rebif has an effective rate quoted at 30%. Which is slightly less than 1/3.

2. rebif from my understanding hasnt got the history of improvements that we hear people on tovaxin supposedly have reported.

3. rebif requires 3 injections per week. I am guessing the tovaxin trial will require less

4. rebif can cause many side effects while tovaxin appears to be better tollerated

Under the above assumptions, i would personnally chose the tovaxin trial over rebif. Which is suprising for me, as I would kick and scream like all h%$£ if i found out i was on placebo.

If i had ANY signs of a relapse, i would fairly quickly make noise also. Dont forget, at the end of the year, you get it for sure. But one year can be a long time in MS. It would depend on how bad my relapses were in the past.

And dont forget, you can always pull out of the trial. Even though this wont be good for the general MS public, i think you need to look after yourself first.
Just my thoughts.

Thanks, CureOrBust. Those are some good thoughts and my thinking has been along the same lines. In regards to your points:

1. Yup. Rebif's effectiveness rate is *very* underwhelming, especially when you consider the $$$ it costs.

2. I've heard that Tovaxin has a higher rate of effectiveness, but are there any other stories out there other than Tim's...? I just seems like there should be other people telling a similar tale by now.

(Naturally, if I'm accepted into the trial, I'll tell all y'all EVERYTHING! I'll put it all into my blogspot.)

3. So true. And I, not being a sadist, would be grateful to reduce my time spent as a human pincushion.

4. I've just started the Rebif, so I am definitely feeling these side effects. I've heard that they get better & go away eventually, but Tovaxin seems like a safer, more comfortable way to fly...

So far my MS isn't too wicked or progressive. I have vertigo, a numb left hand, fatigue... I think I could hang in there for a year on the placebo, as long as I knew I'd be getting The Real Thing after that... I think I'd say "yes" if they accepted me. I wonder what my neuro would say.

Guess I'll just have to wait & see what happens. Probably nothing will. I shouldn't get my hopes up too high.

If anyone has any more Tovaxin info, please post it... I appreciate it all.

[OregonMom]

Okay, I just found a site with some more details about the upcoming clinical trial. From http://www.msrc.co.uk/index.cfm?fuseact ... ageid=1312:

"Of the 150 patients participating in the trial, 100 will receive Tovaxin and 50 will receive the placebo."

So... only 150 patients will be selected. I probably won't be one of them, but ya never know.

[CureOrBust]

It just seems like there should be other people telling a similar tale by now.

This also bothers me a little that there arent more singing its praises. But from what I have herd there was something like a 90%+ effectiveness; which compares pretty good to the 30% of most current treatments. I guess we will have to wait and see.

I've just started the Rebif, so I am definitely feeling these side effects. I've heard that they get better & go away eventually, but Tovaxin seems like a safer, more comfortable way to fly...

I was on rebif for about 4 months earlier this year. When I started it, i was coming off prednisone. I had no side effects apart from injection site reactions. UNTIL i weened myself off prednisone. When I stopped prednisone, my side effects just got worse and worse. Obviously it didnt agree with me. In a way I was glad it didnt work, as now i am on oral treatments, with one being a possible cure (hopefully it will work!).

By the way, what made the injections bearable for me (as i am a big baby when it comes to pain) was a local anesthesia topical cream called emla, which can be bought from the chemist without a prescription (at least in australia).