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Joined: May 04, 2006 Posts: 3372 Location: Mid-Michigan
Posted: Sun Mar 16, 2008 1:46 pm Post subject:
I'm wondering how much the talk of a phase III is just "going through the motions" and will never materialize.
As someone mentioned, they're treating large numbers of people off label, covered by health insurance, the results of which are obviously being documented.
I'm not an expert on FDA procedure but in this case, considering the hopelessness of the disease and the effectiveness of the treatment, I think that presenting the FDA with large numbers of favorable enough results, in the end is going to negate the need for a phase III.
If going through a phase III proves to be a necessary formality, it sounds like Accential has already got the wheels in motion. Unless some terrible problem exposed itself along the way, I would expect treatment to proceed as if it were FDA approved and the phase III would be nothing more than obligatory.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
So, that's just a matter of dose. I had understood the "reboot" concept, and I totally agree when you say it's a promising approach. But I couldn't find any reference of dosages which are used with "normal" cyclophosphamide, so I couldn't compare with HDC. It just seemed to me strange that so much "buzz" was made about an already existing treatment.
Well, let's wait and see, or maybe "hope and see".
Joined: May 04, 2006 Posts: 3372 Location: Mid-Michigan
Posted: Mon Mar 17, 2008 7:06 am Post subject:
Jean wrote:
But I couldn't find any reference of dosages which are used with "normal" cyclophosphamide, so I couldn't compare with HDC.
Hi Jean,
In trying to find documentation of the different dosages I came across this interesting article that I haven't had a chance to read yet http://www.msu.edu/~lyonro/therapies.pdf I'll edit and erase this link in a couple of days.
It talks about HDC and MIGHT go into the different dosages used with cyclophosphamide to "reboot" the immune system and that used for long term suppression.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Thanks for that link, some very interesting lunch time reading.
What was interesting from the the paper was that the stem cell replacement with prior chemo treatment doesn't 'wow' with results when put next to HiCy.
In fact the results are very similar. One other thing that became obvious is that with every single treatment in development the message seems to be 'earlier the better' yet the attitude of the establishment seems to be 'wait until you are severely disabled'.
Joined: May 04, 2006 Posts: 3372 Location: Mid-Michigan
Posted: Mon Mar 17, 2008 3:45 pm Post subject:
Jamie wrote:
In fact the results are very similar. One other thing that became obvious is that with every single treatment in development the message seems to be 'earlier the better' yet the attitude of the establishment seems to be 'wait until you are severely disabled'.
True, but I think the medical establishment is only guilty of not being able to adapt quickly enough for this rapidly changing environment. Very recently it legitimately WAS wiser to wait until the point of desperation before trying unproven treatments. I probably don't need to say it, but you still have to chose unproven treatments very wisely and knowingly. Even now they are not something that everyone is willing to consider.
Jamie wrote:
What was interesting from the the paper was that the stem cell replacement with prior chemo treatment doesn't 'wow' with results when put next to HiCy.
I'm glad you noticed that. ASCT is riskier and has a longer and riskier recovery period. For what additional benefit?
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
I have to say that your Neuro is pretty uneducated. It is common practive at this point to get patients on a drug as soon as possible. I would get a new Neuro but in actuality you have with Dr. Kerr and Dr. Hammond. I would proceed as soon as possible with the Revimmune and get the test through your primary.
I head down to JH for my six month check up next week. No activity on my MRI last week. We will see what happens this spring since I have not had a spring with no activity in about four years.
I regards to the other questions the dose of Cytoxan is determined by weight. I am not sure of the formula but Dr. Brodsky and company have been at this for along time.
I am not 100% sure why the phase III does not need a placebo. They are trying to prove improvment in disability. (40-60%) This is only going to happen if the disease is stopped. The general MRI will also show no new activity. I will ask Dr. Kerr next week why the control group is not needed.
I'm wondering how much the talk of a phase III is just "going through the motions" and will never materialize.
As someone mentioned, they're treating large numbers of people off label, covered by health insurance, the results of which are obviously being documented.
I'm not an expert on FDA procedure but in this case, considering the hopelessness of the disease and the effectiveness of the treatment, I think that presenting the FDA with large numbers of favorable enough results, in the end is going to negate the need for a phase III.
If going through a phase III proves to be a necessary formality, it sounds like Accential has already got the wheels in motion. Unless some terrible problem exposed itself along the way, I would expect treatment to proceed as if it were FDA approved and the phase III would be nothing more than obligatory.
Bob
it seems, now, a few months on that this is the case. Off label is the norm, and peoples results are being added to the phase 3.
It seems to be a done deal as long as nothing goes wrong.
Before you leave Jamie, or they may wait till you get home, they will ask you to use the data in th trial coming up. You don't need to let them of course.
As far as I know everyone is letting them so think, when Phase 3 goes if it needs too, they will have a stack of completed paperwork ready to be submitted as completed.
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