Summary of the pipeline

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

Summary of the pipeline

Postby dignan » Tue Aug 02, 2005 11:55 am

Here's a summary I just put together for myself that I thought I'd share. I've compiled all the substances I could find on the net currently in the research pipeline as disease-modifying treatments for MS. I didn't include detailed information, I just wanted to list what is out there and where it stands (to the best of my ability). Generally, I've included the name of a substance, the brand name (if applicable) and the name of the organization testing or marketing the substance.

If anybody sees mistakes or has stuff to add, please let me know.


MS Disease-modifying Treatment Pipeline

May 12, 2013


Approved
1. Aubagio (aka Teriflunomide, HMR 1726) (Sanofi-Aventis)
2. Avonex (intramuscular interferon beta 1a) (Biogen Idec)
3. Betaseron (Extavia) (subcutaneous interferon beta 1b) (Bayer / Novartis)
4. Copaxone (glatiramir acetate) (Teva)
5. Gilenya (aka fingolimod or FTY720) (Novartis)
6. Novantrone (mitoxantrone) (Merck Serono / OSI)
7. Rebif (subcutaneous interferon beta 1a) (Merck Serono)
8. Tecfidera (BG-12) (Biogen Idec)
9. Tysabri (natalizumab) (Biogen Idec / Elan)


Treatments used “off label”
1. Antibiotics: Doxycycline, Amoxicillin, Rifampin, Metronidazole — OR — Doxycycline, Roxithromycin, Metronidazole — OR — Rifampin, Azithromycin, Flagyl
2. Azathioprine (aka Imuran)
3. Corticosteroids (especially methylprednisolone)
4. Cyclophosphamide (aka Cytoxan)
5. Intravenous Immune Globulin (IVIg)
6. Low-Dose Naltrexone (LDN)
7. Methotrexate
8. Mycophenolate mofetil (aka Cellcept)
9. Plasma exchange (aka plasmapheresis)


Phase III Trials
1. Autologous hematopoietic stem cell transplantation (Multiple Sclerosis International Stem Cell Transplant Trial)
2. Campath (aka alemtuzumab or Lemtrada) (Genzyme)
3. Daclizumab (aka Zenapax) (also in a phase 2 trial) (Facet Biotech, Biogen-Idec)
4. Gilenya (aka fingolimod or FTY720) (PPMS) (Novartis)
5. Interferon beta 1a – PEGylated (bi-weekly or monthly injection) (Biogen Idec)
6. Laquinimod (aka ABR-215062) (Teva)
7. Masitinib (SPMS and PPMS) (aka Kinavet or AB1010) (AB Science)
8. Minocycline (MS Society of Canada, MS Scientific Research Foundation)
9. Ocrelizumab (aka R1594) (trials for PPMS and RRMS) (Genentech, Roche, Biogen)
10. Progestin and Estradiol (Hospices Civils de Lyon)
11. Revimmune (aka Cyrevia OR high-dose cyclophosphamide) (Accentia Biopharmaceuticals)


Phase II Trials
1. Abatacept (National Institute of Allergy and Infectious Diseases)
2. ACT-128800 (aka ponesimod) (Actelion)
3. AIN457 (aka secukinumab) (Novartis)
4. Alferon N Injection (Hemispherx Biopharma)
5. Amiloride (Oxford University) (trial for primary progressive patients)
6. ATL/TV 1102 (Antisense Therapeutics / Teva)
7. Autologous hematopoietic stem cell transplantation (HALT MS)
8. Bacille Calmette-Guèrin (BCG) Vaccine
9. BAF312 (Novartis)
10. BHT-3009-01 (aka DNA vaccine) (Bayhill Therapeutics)
11. Chronic cerebrospinal venous insufficiency (CCSVI) treatment (University of Ferrera and Bellaria Hospital, Bologna)
12. E2007 (Eisai)
13. EGCg (aka Epigallocatechin-Gallate) (Charite University, Berlin)
14. Enkorten (aka FAR404) (Farmacija)
15. Erythropoietin (aka EPO) (Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH)
16. ESP (an analogue of a metabolite of azathioprine) (Biomolecular Pharma / Mount Allison University)
17. Estroprogestins (with IFN beta 1a) (S. Andrea Hospital)
18. Firategrast (aka SB-683699 and T-0047) (oral) (Glaxosmithkline / Tanabe)
19. Fluoxetine (aka Prozac) (SP, PP & RRMS) (University Medical Center Groningen)
20. Flupirtine (Bayer / Schering)
21. GEM-SP (SPMS) (Gemac Pharma)
22. GNbAC1 (Monoclonal antibody against MSRV/HERV-W) (GeNeuro)
23. Helminth-induced immunomodulation therapy (HINT) (2 studies: University of Wisconsin, Rigshospitalet, Denmark)
24. Hookworm (WIRMS – Worms for Immune Regulation in MS) (UK) (RRMS)
25. Hydroxyurea (PPMS) (S. Andrea Hospital)
26. Idebenone (National Institute of Neurological Disorders and Stroke)
27. Interferon alpha (oral) (University of Texas-Houston)
28. Lamotrigine (with Interferon Beta 1a) (Cantonal Hospital of St. Gallen, Switzerland)
29. Lipitor (aka atorvastatin) (Pfizer)
30. Lithium (US Department of Veterans Affairs)
31. LY2127399 (Anti-BAFF Human Antibody) (Eli Lilly)
32. Melatonin (Tehran University of Medical Sciences)
33. Mesenchymal Stem Cells (4 trials)
34. Methotrexate – intrathecal
35. Minocycline (2 trials: 1 with copaxone, 1 with rebif)
36. MIS416 (trial for progressive MS) (Innate Therapeutics)
37. Mycophenolate mofetil (aka Cellcept) (with Avonex)
38. Myelin Peptides (epicutaneous immunisation) (Medical University of Lodz, Poland)
39. MyeloXen (Xenetic Biosciences and Pharmsynthez)
40. NT-KO-003 (Advancell and Neurotec Pharma)
41. NeuroVax (Immune Response BioPharma)
42. Ofatumumab (aka HuMax-CD20) (Genmab and Glaxosmithkline)
43. Olesoxime (TRO19622) (Trophos)
44. Omega-3 fatty acids (University of Washington)
45. ONO-4641 (Ono Pharmaceutical)
46. Phenytoin (University College, London)
47. PI-2301 (Merck Serono)
48. Pixantrone (aka BBR 2778 ) (Cell Therapeutics)
49. Raltegravir (Isentress) (Queen Mary University of London)
50. Riluzole (with Avonex) (UCSF)
51. RPI-78M (Nutra Pharma / ReceptoPharm)
52. RTL1000 (Artielle ImmunoTherapeutics)
53. Stem cell transplant from donor (allogeneic) (Duke University)
54. Tovaxin (aka Tcelna) (Opexa)
55. Trimesta (oral) (estriol) (with copaxone) (Adeona Pharmaceuticals)
56. Vitamin D3 (with calcium) (Johns Hopkins University, Carmel Medical Center, Merck, Charite University, University of Turku)
57. Zocor (aka simvastatin) (RRMS and SPMS) (Merck Serono)


Phase I Trials
1. Adrenocorticotrophic Hormone (ACTH, administered as Acthar Gel) (with interferon beta) (University of Southern California)
2. ARX424 (Merck Serono)
3. ATX-MS1467 (Apitope Technology / Merck Serono)
4. AZ01 (Interferon beta 1a – pegylated – bi-weekly or monthly injection) (Allozyne)
5. BaroFeron (aka NU100) (Nuron Biotech and BaroFold)
6. BIIB033 (aka Anti-Lingo) (Biogen)
7. CS-0777 (Daiichi-Sankyo)
8. ELND002 (Elan Pharmaceuticals)
9. Extended Release Formulation of IFNbeta-1a (Merck Serono)
10. GBR 500 (Glenmark Pharmaceuticals)
11. GSK1223249 (NOGO-A mAb) (GlaxoSmithKline)
12. GSK2018682 (sphingosine-1 phosphate receptor-1) (GlaxoSmithKline)
13. Lipoic acid (Oregon Health and Science University)
14. Low Fat Diet (Oregon Health and Science University)
15. Mesenchymal stem cell transplantation (autologous) (Cleveland Clinic)
16. MOR103 (MorphoSys)
17. NI-0401 (NovImmune)
18. PDA-001 (cenplacel-L) (Celgene Cellular Therapeutics)
19. Peptide-coupled, peripheral blood mononuclear cells (Hamburg, Munich, Chicago)
20. Prolactin (aka NTx-488) (Stem Cell Therapeutics / University of Calgary)
21. RGN-352 (RegeneRx)
22. RPC1063 (Receptos)
23. ShK-186 (Kineta)
24. TK54 (LTKfarma)
25. Valomaciclovir (aka EPB-348) (Epiphany Biosciences)
26. XP23829 (XenoPort)


For a bit more information, see my blog:
http://mspipeline.wordpress.com/
Last edited by dignan on Wed Jul 17, 2013 12:07 pm, edited 487 times in total.
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Postby Arron » Tue Aug 02, 2005 4:14 pm

dignan, don't take this the wrong way, but I think I love you

LOL-- this is great. I hope you won't mind if we use this list in other places on the site e.g. front page-- and credited to you, of course?
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby dignan » Tue Aug 02, 2005 5:11 pm

Gee Arron...I don't know what to say...you're great...really...but my girlfriend and I are pretty serious...anywho...

I'm glad you like it. Of course you can do whatever you like with the list. I don't need to be credited.
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Postby bromley » Tue Aug 02, 2005 11:56 pm

Dignan,

Excellent post. The only drugs in the trial that I know of which aren't mentioned are the Neuren drugs (see my post on Neuren). One is going into Phase III trials with the US Army.

There are some neuro-protective drugs being trialled by the UK MS Society for those with SPMS - I'll find out the names.

Some on the list are bound to fall by the wayside but that should still leave some which should turn out to be better than the current treatment options.

All we need is something to stop the damage being done, protect what we have left, and initiate repair and regeneration. Hopefully, some on the list will deliver some of these.

I foresee a much more hopeful future but, as usual, it will be some time before any of these make it to market.

Not sure what Aaron is taking but declarations of love on a public website suggest that it is not on the approved list.

Ian
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Postby Arron » Wed Aug 03, 2005 12:03 am

hahahahha... thanks for indulging my sometimes twisted sense of humor. This list is a project we've had on the backburner for quite some time, so it was really great to have it pulled together in such a fashion.

Much LOVE, hahahha
-arron
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Postby bromley » Wed Aug 03, 2005 3:27 am

Arron,

Would you mind telling us something about yourself. All I know is that you live in California and declare your love to men you haven't ever met.

You're something of a mystery - a sort of Wizard of Oz of the MS world.

Can you say anything about how you got involved with ThisIsMS? Who's the guiding force behind it? Are you the owner or an employee?

It's always said that MS is a mystery but so is Arron and ThisIsMS. Can you enlighten us further?

Bromley
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Postby dignan » Wed Aug 03, 2005 9:02 am

Bromley,
Thanks for the pointer to Neuren. It's tough to figure out what to include from them because they make passing references to MS, but from their website info, it's not their focus at all. Because of that I just put in their NNZ-2566 as a pre-clinical candidate. I was kind of torn about including anything pre-clinical since the chances of failure are huge at that point.

That's it.
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Postby bromley » Wed Aug 03, 2005 11:21 am

Dignan,

You're right about Neuren. But they do mention MS as disease which their drugs might help.

I found the reference to the neuro-protective drug that I mentioned:


we have been awarded a grant by the Multiple Sclerosis Society to carry out a clinical trial to test the neuroprotective effects of one such sodium channel blocking drug, lamotrigine, in people with the secondary progressive form of MS. We will randomize people in the trial to receive treatment either with lamotrigine or with an identical placebo (i.e. dummy) tablet for two years.



Not sure what lamotrigine is or who manufacturers it, or the status of the trial (they are looking at effectiveness rather than safety so I assume Phase II?

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Postby bromley » Wed Aug 03, 2005 12:10 pm

Dignan,

I'm feeling like a train spotter. Some more to add.

Serono:

Osteopontin (remyelinating agent) (preclinical)
MMP-12 inhibitor (Phase 1)
JNK inhibitor (phase 1)


Aspirin is also in trial (for fatigue and memory)

Quite a few Japanese pharmaceutical firms are developing MS drugs. I'll come back with some more names in due course.

What would be nice is to develop a table showing each of the drugs, and links to trial participation information, trial results, related research papers etc, key dates etc. May be those participating in trials / finished trials could feed in their views (if they know they're not on the placebo). At the end of the day this info offers hope - more effective treatments that should make our lives better / more bearable in the future. Competition should also push the drugs companies to start delivering much better treatments - for too long a small number of companies have made substantial profits from relatively ineffective treatments. I'm very suspicious that the injectibles all offer just 30% efficacy - it's time this deal was broken.

Bromley
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Postby dignan » Wed Aug 03, 2005 1:16 pm

Bromley,
Thanks for the additions. I added lamotrigine (seems to be a Glaxosmithkline drug) to Phase II and the three Serono drugs you mentioned. I am not adding aspirin because I'm only including disease-modifying agents, nothing that just treats symptoms. It would be worthwhile to start a separate list with symptom-management treatments, but it's not something I'm taking on. Looking forward to seeing what else you unearth.
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Postby bromley » Thu Aug 04, 2005 9:15 am

Dignan,

This will be my final post on this - I've got to get myself a real hobby.


- Non-antibacterial tetracycline (Paratek Pharmaceuticals)
- RPI-78M (Nutra Pharma)

Not sure of the status but assume pre-clinical.

Bromley
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Postby dignan » Thu Aug 04, 2005 10:41 am

Thanks for the help. Good luck with that hobby.
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Postby dignan » Wed Aug 10, 2005 8:28 am

Here's a fun little exercise...

There are 40 substances in Phase II right now. Through the 90's, about 40% of drugs tested in Phase II moved on to Phase III trials. So using those stats that means about 16 of the current 40 substances being tested for MS would likely move on to Phase III trials.

There are 7 substances currently in Phase III trials and I assume Tysabri will either be pulled, or will be back on the market by early next year. The remaining 6 substances in Phase III will be there until AT LEAST the end of 2007.

So, it's quite possible that in 2008, there will be over 20 treatments for MS that will be in Phase III trials. So many that it may actually get hard to keep up with everything in Phase III. A change I look forward to.
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Postby LisaBee » Mon Aug 15, 2005 4:53 pm

Hello dignan,

Thanks so much for putting this list together. I did not realize that inosine, alpha lipoic acid, EFAs, and <gasp> Vitamin D are actually going through clinical trials, at least at some stage. With all of the attention about the epidemiology of sunlight/vitamin D and MS out there, and the extensive recent publications on immunomodulatory properties of Vitamin D, it is heartening to see someone pick it up. Go Canada! There are indications that Vitamin D may protect against developing MS, but I haven't seen much research on whether it might actually help treat it. I get frustrated with the pace of the drug development, and the testing of the "alternatives" is particularly exciting because those are currently available to people if the controlled trials show some positive outcomes.

Is there information on the protocol for vitamin D study, such as dosage? I hope they are not just using the standard 400IU per day, since so much of the newer research is suggesting that is not adequate, particularly for individuals with limited sunlight exposure.

Thanks again!
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Postby dignan » Tue Aug 16, 2005 8:11 am

The only information I found on it is from the Canadian MS Society's 2004 Research Review document:

http://www.mssociety.ca/en/research/pdf ... 202004.pdf


Here is all the info from that report on the vitamin D study:

Paul O’Connor, MD and Melanie Ursell, St. Michael’s Hospital, Toronto Biomedical Research – A phase 1 dose escalation study of Vitamin D3 with calcium supplementation in patients with MS

$35,000 – Start date: May 2004
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