This Is MS Multiple Sclerosis Knowledge & Support Community

We know a sizable percentage are doomed to failure and at some level it's nice to get those failures labeled and out of mind so that we can focus on others which might offer more hope.

Like Carol I appreciate your constant search for and cataloging these things to make look-up easier for the rest of us.
Bob

we ALL appretiate your work dignan.

Another downgrade to report: gemfibrozil going from phase 1 to pre-clinical based on this:

NMSS reference

Revimmune is Accentia Biopharma's high-dose cyclophosphamide treatment. Based on the quote below from their website, I'm moving it to phase 3 -- woohoo!



"Revimmune complements our strategy of developing late-stage, "disruptive" clinical products based on already approved active pharmaceutical ingredients. This product strategy is the basis of our lead product, SinuNase(TM), in which the active pharmaceutical ingredient is the approved antifungal, amphotericin B, and which we were able to advance directly into a Fast Tracked Phase 3 clinical trial for chronic sinusitis," said Dr. Frank E. O'Donnell, Jr., Chairman and Chief Executive Officer of Accentia Biopharmaceuticals. "Revimmune offers the hope of sustained remissions and cures for autoimmune diseases such as MS, thereby eliminating, or reducing dependence on chronic immunosuppressive therapies, which we believe are more toxic, carcinogenic, inadequate, inconvenient, and very expensive, especially in the case of monoclonal antibodies. Revimmune's use would also obviate the risk and expense of allogeneic (donor) stem cell transplantation to treat severe cases of autoimmune diseases. After consultation with the FDA, Accentia is preparing an IND for severe refractory multiple sclerosis and is proposing to enter Phase 3 clinical trials to support licensure under the 505(b)(2) regulatory pathway, which is an abbreviated regulatory process available when dealing with approved active pharmaceutical ingredients. The IND incorporates a novel risk management program to ensure appropriate patient selection, supportive care, and tracking of outcomes, which we believe will be critical to reimbursement coverage and malpractice protection for healthcare providers."

link

Dignan,

Good find. I'm surprised Lyon hasn't commented, as he's a big fan of high-dose cyclophosphamide. The company are making some big claims - not sure how it fits with the regime used by Dr Freedman (Bone Marrow Transplantation) which also uses high dose chemo drugs.

Ian

That is a good find! Thanks again for your work dignan.

While "big fan" probably isn't the exact term I would use, I have to admit that I am VERY interested in the "rebooting" technique and I wish most people, even most researchers, realized what a vast departure this is from long term suppression, even when the same chemicals are used.

By definition "suppression" doesn't and could never offer hope of stopping the disease process. Suppression means slowed down and with a disease as heinous as MS any sensible person wants the disease process STOPPED and any degree of slowed down isn't good enough.

Only an alternate technique offers hope of stopping MS and rebooting is an alternate technique.

Bob

Just for the sake of trying something new, I've started a blog about the pipeline.

http://mspipeline.wordpress.com/


Happy Canada Day!

Just a question : are you sure Campath is in phase III ? I've seen a typo on an article from thisisms.com, but I can't find any phase III study about Campath in multiple sclerosis on clinicaltrials.gov and on Genzyme website.

Jean,

The Phase III trial has not started - it should start this year. There will be two Phase III trials - one for those who have not had any treatment (CRAB drugs) and one for those who still had active disease despite being on one of the CRAB drugs.


Ian

Bromley knows what he's talking about. Here is the quote and link on which I base putting Campath in phase 3:


"Significant progress has been made toward the initiation of two planned Phase 3 clinical trials, one that will include previously untreated patients and one that will involve patients receiving an approved therapy whose disease remains active. These Phase 3 studies are expected to begin this year, following FDA clearance."

http://www.genzyme.com/corp/media/GENZ%20PR-050207.asp

I took omega-3 fatty acids off the list because I couldn't find a reference to a disease-modifying trial (I know there is a depression trial going on), but I just found something from the NMSS, so I'll add omega-3 to the phase 2 list.


Omega-3 fatty acid: An open-label study of this popular supplement in 10 people with MS showed a 52% reduction in “matrix metalloproteinase-9,” which is associated with MS inflammation. A two-year study of 100 people with relapsing-remitting MS is now underway in Norway to further examine omega-3's effect on disease activity as seen on MRI.

MS Society Website

anyone know the dosage in the previous or current trials of omega-3?

OK, found the past study stuff. Amazing what you can do when you try...
http://www.nationalmssociety.org/docs/H ... trials.pdf
Not only was it in a link provided somewhere here already, but I had already downloaded it.

Agent: Omega-3 Fatty Acid Supplementation COMPLETED
Purpose of study: To assess safety and effectiveness on matrix metalloproteinase-9 production
Possible mechanism: Immunomodulatory, inhibits matrix metalloproteinase-9
Study description: Open label
Dose/route: 8 capsules bid po with daily dose of 1900 mg docosahexaenoic acid and 2900 mg eicosapentaenoic acid
Outcome parameters: Matrix metalloproteinase-9 levels from serum and levels secreted from peripheral blood mononuclear cells
Type of MS: RR
Number of Subjects: 10
Start date: August 2003
Observation period: 3 months
Investigators: G. Marracci and others
Sites: Oregon Health & Science University, Portland
Results/Publications: After 3 mos, 52% decrease in matrix metalloproteinase-9 levels secreted from peripheral blood mononuclear cells, and omega-3 fatty acid blood levels significantly increased; no significant decrease in serum matrix metalloproteinase-9 levels; most common adverse event, “fishy aftertaste” (Abstract #P03.119, AAN 2005)
Funding: NIH, DVA, Nancy Davis Center Without Walls, Vital Nutrients
ClinicalTrials.gov Link: Not available Last update: 2005

Hi,

during my holidays I finaly found the time to go through
this
MS research roundup from 2006, which was posted on this forum some time ago.
Based on this document I'd like to contribute the following drugs to the overview in this thread:

- T-Cell receptor peptide vaccination:
anti V5.2/V5.3 mAb
Phase-II was successful (in 2002)

- Anti IL-12:
ABT-874
and
CNTO-1275
in Phase-II

--Frank

Frank, thanks for doing that digging. Unfortunately, it looks like both ABT-874 and CNTO-1275 have both failed in the last 6 months. There is nothing about the MS trials on either company's website any more. I'll look into the anti V5.2/V5.3 mAb though.