Summary of the pipeline

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Postby rainer » Wed Aug 27, 2008 9:12 pm

Not sure if this was posted yet, minor update (posted over at Accelerated Cure):

BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis

BioMS Medical Corp. (CA:MS: news, chart, profile) , a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Drug Safety Monitoring Board (DSMB) for the MAESTRO-01 trial has conducted the scheduled interim analysis of efficacy and safety and has recommended that the trial continue to completion. MAESTRO-01 is the pivotal phase II/III Canadian and European study of dirucotide (MBP8298) in patients with secondary progressive MS.

The interim analysis included patients from the first 200 to complete MAESTRO-01 and assessed the likelihood of the study reaching its primary endpoint at the end of the trial in MS patients with the target HLA-DR2 and/or HLA-DR4 immune response genes. The DSMB analysis also included a scheduled review of safety information.

Based on the DSMB decision, Eli Lilly and Company has agreed to provide the $10 million milestone payment to BioMS as part of the terms of the licensing and collaboration agreement.

"We are very encouraged by the safety board's recommendation," said Kevin Giese, President and CEO of BioMS Medical. "This positive review is an important milestone for BioMS and our partner, Eli Lilly and Company, and moves us one step closer to our goal of bringing this important therapy to multiple sclerosis patients."

"We are pleased by the results of the interim analysis and look forward to final efficacy and safety data from this trial next year," said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and Director of the MS Research Clinic at the Ottawa Hospital. "If successful, this novel therapy administered only twice per year, could help a large underserved population with late stage MS."
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Postby dignan » Sun Sep 14, 2008 8:05 pm

Just added 2 new treatments to the pipeline:

- CS-0777 in phase 1 from Daiichi-Sankyo (I had one on the list from Daiichi but I took it off because there was no sign of anywhere on the web, but I have a feeling this is it, come back to life)
http://clinicaltrials.gov/show/NCT00616733

- Flupirtine in phase 2 from Bayer / Schering
http://clinicaltrials.gov/show/NCT00623415
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Postby dignan » Thu Oct 23, 2008 12:06 pm

At Bromley's prompting, I added "far infrared irradiation" to phase 1.

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Postby dignan » Tue Nov 11, 2008 10:46 pm

I removed Anti-CD154 (aka IDEC-131 or E6040) (Dartmouth) from the phase 2 list based on page 85 of this review (an interesting read if you're a nerd like me):

http://www.sven-meuth.de/Files/pdf/paper/2008/P28.pdf
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Postby patientx » Fri Nov 14, 2008 11:00 am

This is an interesting article. But the authors make one point I don't understand. In the section on virostatics, they state

In a double-blind, placebo-controlled
study 60 RRMS patients received aciclovir (800
mg/day) acting against herpes viruses, or placebo
over 2 years. In summary, there was a statistically
non-significant trend towards fewer relapses (~34%
reduction) in individuals on antiviral medication but
clear proof of efficacy was lacking.


A 34% reduction in relapses wasn't statistically significant? Isn't that about what the current DMDs give?
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Postby dignan » Fri Nov 14, 2008 1:26 pm

I'm no statistician, but I think the statistical significance is related to both the size of the effect, and the sample size. So since the trial was only 60 people, 34% didn't achieve statistical significance. If they got the same effect in a trial of 500 people it would probably be considered significant.
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Postby patientx » Mon Nov 17, 2008 8:00 am

You're probably right. I guess the p value factors in the trial size, and that is what they use to determine statistical significance. I'll have to check my old statistics textbook, to see if it shows how to calculate p values.
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Postby notasperfectasyou » Mon Nov 24, 2008 9:49 pm

Dignan,

It's been a while since I've been back here. Thank you so much for keeping this post uptodate. I've had a similar post that required updating elsewhere and I know how much time I can consume. Thank you.

1) Tovaxin closed up shop yesterday.
2) You might want to add to off-label the ABX treatment that Dr. Sriram is prescribing to my wife, Rifampin, Azithromycin and Flagyl.
3) I think Dr. Schipper is not publishing his trial of Copaxone and NAC. There is a post somewhere that summarizes a phone call I had with him about a year ago.
4) As an observation from an ABX'er - It's VERY interesting to me to see so much of Kim's regimin in the trials in various phases. I count 4 instances of Antibiotics, existing drugs being trialed for MS. NAC, Lipoic Acid, Glucosamine, D3 and B-12. Kim's not on Lipitor, I am - haha. But, seriously, how many of those other drugs are existing drugs approved for other things?

Ken
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Postby dignan » Tue Nov 25, 2008 11:06 pm

Ken,

Thanks, I updated the antibiotic entry.

I'm going to keep tovaxin around for a little while. It took me months to take rituxan for PPMS off the list because I was hoping they'd dredge up some good news in the data. I'm hoping the same for tovaxin. I think Opexa is as good as dead, but Tovaxin may or may not be.

I remember reading your entry on the NAC trial, but I can't find it now. So he said he isn't going to publish? Did he say why?

On your last point, I think the list below are all either non-drugs or already approved drugs:

Phase 3
- Campath (aka alemtuzumab) (Genzyme)
- Cannabinoids - oral (SP/PPMS) (Clinical Neurology Research Group - Plymouth)
- Minocycline (MS Society of Canada, MS Scientific Research Foundation)
- Mycophenolate mofetil (aka Cellcept) (with Avonex)
- Progestin and Estradiol (Hospices Civils de Lyon)
- Revimmune (aka high dose cyclophosphamide or cytoxan) (Accentia Biopharmaceuticals) (refractory MS)
- Trimesta (oral) (estriol) (with copaxone) (Pipex Pharmaceuticals)

Phase II Trials
- Albuterol (aka Proventil) (with Copaxone)
- Doxycycline (with Avonex)
- Erythropoietin (aka EPO) (Stem Cell Therapeutics)
- Estroprogestins (with IFN beta 1a) (S. Andrea Hospital)
- Fluoxetine (aka Prozac) (SP, PP & RRMS) (University Medical Center Groningen)
- Inosine (Thomas Jefferson University)
- Interferon alpha (oral) (University of Texas-Houston)
- Kynurenine (aka Tranilast, Rizoben, 3,4-DAA) (Nuon Therapeutics)
- Lamotrigine (aka Lamictal) (SPMS) (Glaxosmithkline)
- Lipoic acid (with interferon beta) (SPMS) (OHSU)
- Low-dose naltrexone (aka LDN) (UCSF)
- Lipitor (aka atorvastatin) (Pfizer)
- Methotrexate - intrathecal
- Minocycline (2 trials 1 with copaxone, 1 with rebif)
- N-acetyl-L-cysteine (with copaxone)
- Omega-3 fatty acid (Norway)
- Pioglitazone (Actos)
?- Pirfenidone (aka Deskar) (Intermune) (trial for SPMS complete)
- Pravastatin (Nantes University Hospital - France)
- Riluzole (with Avonex) (UCSF)
- Sunphenon EGCg (Epigallocatechin-Gallate) (Charite University, Berlin)
- Testosterone (UCLA)
- Treosulfan (SPMS) (University of Wuerzburg, Germany)
- Vitamin D3 (with calcium) (St. Michael's Hospital - Toronto)
- Zocor (aka simvastatin) (RRMS and SPMS) (Merck Serono)

Phase I Trials
- Sildenafil Citrate (aka Viagra)
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Postby notasperfectasyou » Fri Nov 28, 2008 8:24 pm

Dignan,

I sure hope something comes of Tovaxin and, yes you're absolutely right - Tovaxin and Opexa are separate things. I hope that the Myelin folks can somehow pick it up and run with it, but I'm not very convinced that anyone is going to pour money into it now.

The NAC/Schipper phone call was very short and informal. I don't recall exactly, but my notes are posted in the natural forum, I think. I typed them right after the call.

Viagra! I think that's funny. I had no idea. I really appreciate your keeping this list up.
Ken
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Postby CureOrBust » Sun Dec 14, 2008 7:03 am

I came across another list of drugs on trial, and saw a couple I hadn't heard of before. I searched ThisIsMs and couldn't find any reference.

For example:
ONO-4641 (tablet) by ONO PHARMACEUTICAL CO., LTD.
http://www.ono.co.jp/jp/ir_info/annual/pdf/2008/fi0804.pdf
appears to be in or starting Phase I, similar to FTY720 I think (i.e. S1P receptor agonist).
ONO-4641 (tablet)
ONO-4641, a sphingosine-1-phosphate (S1P) receptor agonist, is developed for the treatment of multiple sclerosis. The drug is a low molecular weight substance having pharmacological actions that keep lymphocytes in lymph nodes, reduce lymphocyte count in the blood, and as a result inhibit infiltration of lymphocytes into lesions. The compound is therefore expected to be an innovative drug for the treatment of auto-immune diseases such as multiple sclerosis, one of the intractable diseases.
US: Phase I / Multiple sclerosis


NBI 5788 (Formerly MSP 771) by Nuerocrine Biosciences Inc.
http://findarticles.com/p/articles/mi_m0EIN/is_/ai_61229642
This one seems to have completed Phase II (or stopped early) and is about to start a Phase IIB.

There are a couple more on the page I couldn't find here (ISIS-107248), but after following one dead end (IR-208 is NeuroVax :x) I realised it was bed time for me, and there may be more renamed.

Oh, the page http://www.patientslikeme.com/forum/show/17020?post_id=186286#186286
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Postby dignan » Sun Dec 14, 2008 11:14 am

Thanks for that info Cure. It's nice to see another list. I did a search on everything not on the list yet, and the only one I'm going to add is ONO-4641. The others are either things that failed already (e.g. ustekinumab is CNTO 1275, which failed in MS), or are drugs that have a different name (ISIS-107248 is ATL1102), or are in trials but I found no evidence that there are any MS trials ongoing. On NBI 5788, I think I took it off the list a while back (2006? 2007?) because I couldn't find evidence that they still were pursuing it for MS.
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Find MS Trials and Contact investigators

Postby mike551 » Fri Dec 19, 2008 12:14 am

this site helps patients find personalized matching trial recommendations and an ability to email the investigators directly.
here are some trials for new treatments for MS
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Postby dignan » Thu Jan 01, 2009 11:42 pm

I added ESP from Biomolecular Pharma and Mount Allison University to the phase 2 list. It is the drug -- mentioned in a few December posts -- that targets the "multiple sclerosis associated measles virus". I think the drug is called ESP, though the drug name isn't mentioned in the press release (http://www.mta.ca/news/index.cgi?id=1800), because ESP is mentioned in this paper: http://www.biomolecularpharma.com/MSMV_Paper.pdf .
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Postby dignan » Sun Jan 04, 2009 7:00 pm

After getting some information about a stem cell trial not on the list, I decided it was time to stop being lazy and add all of the stem cell trials in clinicaltrials.gov to the list (5 new ones). They are all in phase 1 and 2, links below:

http://www.clinicaltrials.gov/ct2/show/NCT00813969

http://www.clinicaltrials.gov/ct2/show/NCT00288626

http://www.clinicaltrials.gov/ct2/show/NCT00273364

http://www.clinicaltrials.gov/ct2/show/NCT00781872

http://www.clinicaltrials.gov/ct2/show/NCT00497952
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