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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."
- 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
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):
This is an interesting article. But the authors make one point I don't understand. In the section on virostatics, they state
Quote:
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?
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.
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.
Joined: Feb 10, 2006 Posts: 358 Location: Northern Virginia
Posted: Mon Nov 24, 2008 10:49 pm Post subject:
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?
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)
Joined: Feb 10, 2006 Posts: 358 Location: Northern Virginia
Posted: Fri Nov 28, 2008 9:24 pm Post subject:
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.
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