HiCy Study

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HiCy Study

Postby patientx » Sat Jul 18, 2009 11:56 am

I posted this in the Revimmune forum, but thought I'd put it here, too:

<shortened url>

Looks like Hopkins might be starting a HiCy trial, but it appears it will be a small study and not multi-center.
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Postby Frank » Sun Jul 19, 2009 6:08 am

Back in 2007 (i guess) they said that there will be a phase-III trial soon. Did this phase-III already started - if so, whats it current state (fully enrolled, how many patients already treated, expected publication date)?
If it hasnt already started, does anyone know why and when it is expected to actually launch?

Thanks
--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby patientx » Mon Jul 20, 2009 6:37 am

Frank,

When I called Hopkins last September to inquire about HiCy, I was told that they were booked solid until early '09 doing it off-label (I'm not a candidate since my lesions do not show enhancement). I was told they had hoped to do a multi-center, phase III trial sometime in early to mid '09. I emailed someone at Hopkins a few months back, and was told the proposed start was pushed back until this fall. Based on the info in the link I found, it appears this has been scaled back, but I don't know for sure. Probably the best thing to do would be to contact Hopkins directly.
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Postby LR1234 » Mon Jul 20, 2009 7:12 am

Patient, So they turned you down for the trials because you don't have enhancement but will they let you have it off label without enhancement? (I don't have enhancement either)
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Postby patientx » Mon Jul 20, 2009 8:08 am

LR1234 wrote:Patient, So they turned you down for the trials because you don't have enhancement but will they let you have it off label without enhancement? (I don't have enhancement either)


My post was a little confusing. Back in Sept. of last year, was when I first contacted Hopkins to get some information about Revimmune. At that time, they were only doing it off-label. I was told at that time I probably wouldn't be a candidate, since my MRI didn't show enhancement (my guess is that they want evidence that the disease still has an inflammatory component). The other thing I was told is that this is a pretty major procedure - full blown chemotherapy.

A few months back (I can't remember exactly when), I emailed the person at Hopkins, for some information gathering, not all related to HiCy. Out of curiosity, I asked again about potential HiCy trials. I was told they hoped to start something late this summer, but it looks like that plan has changed. I never actually applied for the trial.

I think the best thing might be to contact Hopkins. Their requirements for offering the treatment may have changed. If you want, I can PM you with contact info.
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Postby Frank » Fri Jul 24, 2009 12:19 pm

Thanks for the update :)!

--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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