Archive for phase 2

Phase 2

This list gives a bit more detail about the phase 2 trials in progress. Typically, if there is an announcement of a drug successfully completing a trial, I will move it to the next stage before I see a press release or report saying that a new trial is starting. I assume it will move to the next stage. The only exception is for small (20-100 participants) phase 2 trials, as drugs don’t seem to move to phase 3 until they have completed a placebo-controlled phase 2 trial with well over 100 participants.

[updated May 12, 2013]

Phase II Trials

1. Abatacept (National Institute of Allergy and Infectious Diseases)

http://clinicaltrials.gov/show/NCT01116427

2. ACT-128800 (aka ponesimod) (Actelion)

http://www1.actelion.com/sites/en/scientists/development-pipeline/phase-2/ponesimod.page

3. AIN457 (aka secukinumab) (Novartis)

http://www.clinicaltrials.gov/ct2/show/NCT01051817

4. Alferon N Injection (Hemispherx Biopharma)

http://www.hemispherx.net/content/rnd/product_candidates.htm

5. Amiloride (Oxford University) (trial for primary progressive patients)

http://www.mssociety.org.uk/ms-news-and-research/ms-research/research-projects/cure#ACTION

http://news.bbc.co.uk/2/hi/health/7086911.stm

http://brain.oxfordjournals.org/content/134/2/571.long

6. ATL/TV 1102 (Antisense Therapeutics / Teva)

http://www.tevapharm.com/en-US/Media/News/Pages/2009/1555769.aspx

www.antisense.com.au/!upload_files%5Cattachment%5CAntisense%20Web%20Report.pdf

http://www.antisense.com.au/_116.asp

7. Autologous hematopoietic stem cell transplantation (HALT MS)

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

8. Bacille Calmette-Guèrin (BCG) Vaccine

http://www.clinicaltrials.gov/ct/show/NCT00202410

9. BAF312 (Novartis)

http://www.clinicaltrials.gov/ct2/show/NCT00879658

http://www.clinicaltrials.gov/ct2/show/NCT01185821

http://www.novartis.com/innovation/research-development/clinical-pipeline/index.shtml

10. BHT-3009-01 (aka DNA vaccine) (Bayhill Therapeutics)

http://www.bayhilltx.com/BHT-3009.html

http://www.bayhilltx.com/PressReleases.html

11. Chronic cerebrospinal venous insufficiency (CCSVI) treatment

http://www.clinicaltrials.gov/ct2/show/NCT01264848

http://www.clinicaltrials.gov/ct2/show/NCT01371760

http://www.clinicaltrials.gov/ct2/show/NCT01201707

http://www.clinicaltrials.gov/ct2/show/NCT01205633

http://www.clinicaltrials.gov/ct2/show/NCT01089686

http://www.ctv.ca/generic/WebSpecials/pdf/YMVA_4198_Zamboni_final.pdf

http://www.ncbi.nlm.nih.gov/pubmed/20018140

http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=116641&XNSPRACHE_ID=2&XNKONGRESS_ID=126&XNMASKEN_ID=900

12. E2007 (Eisai)

http://www.eisai.com/research/index.html

13. EGCg (Epigallocatechin-Gallate)

http://www.clinicaltrials.gov/ct2/show/NCT01417312

http://www.clinicaltrials.gov/ct2/show/NCT01451723

http://www.clinicaltrials.gov/ct2/show/NCT00799890

http://www.clinicaltrials.gov/ct/show/NCT00525668

http://www.clinicaltrials.gov/ct2/show/NCT00836719

14. Enkorten (aka FAR404) (Farmacija)

http://www.farmacija.co.ba/eng/multipla.htm

http://www.farmacija.co.ba/eng/download/v4Mehmedika-Suljic%20Bangkok%202009.pdf

http://www.farmacija.co.ba/eng/download/v4Alajbegovic%20Bangkok%202009.pdf

15. Erythropoietin (aka EPO) (Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH)

http://www.clinicaltrials.gov/ct/show/NCT00355095

16. ESP (an analogue of a metabolite of azathioprine) (Biomolecular Pharma / Mount Allison University)

http://www.biomolecularpharma.com/MSMV_Paper.pdf

http://www.biomolecularpharma.com/ms_drug.php

17. Estroprogestins (with IFN beta 1a) (S. Andrea Hospital)

http://www.clinicaltrials.gov/ct/show/NCT00151801

18. Firategrast (aka SB-683699 and T-0047) (oral) (Glaxosmithkline / Tanabe)

http://www.clinicaltrials.gov/ct/show/NCT00395317

http://www.mt-pharma.co.jp/shared/show.php?url=../e/develop/pipeline/index.html

19. Fluoxetine (aka Prozac) (SP, PP & RRMS) (University Medical Center Groningen)

http://www.controlled-trials.com/ISRCTN38456328

http://dissertations.ub.rug.nl/faculties/medicine/2009/j.p.mostert/?pLanguage=en&pFullItemRecord=ON

http://www.ncbi.nlm.nih.gov/pubmed/20178822

20. Flupirtine (Bayer Schering)

http://clinicaltrials.gov/show/NCT00623415

21. GEM-SP (SPMS) (Gemac Pharma)

http://www.gemacpharma.com/node/47

http://www.biolsci.org/v04p0150.htm

http://www.ncbi.nlm.nih.gov/pubmed/19548873

http://www.ingentaconnect.com/content/ben/aiaamc/2010/00000009/00000003/art00004;jsessionid=1qsghncm1oelj.alexandra

22. GNbAC1 (Monoclonal antibody against MSRV/HERV-W) (GeNeuro)

http://www.clinicaltherapeutics.com/article/S0149-2918%2812%2900649-2/abstract

http://www.geneuro.com/en/technologies/pipeline.php

23. Helminth-induced immunomodulation therapy (3 studies: University of Wisconsin, Rigshospitalet, Denmark, Charite University)

http://www.clinicaltrials.gov/ct2/show/NCT01413243

http://www.clinicaltrials.gov/ct2/show/NCT00645749

http://www.clinicaltrials.gov/ct2/show/NCT01006941

24. Hookworm (WIRMS – Worms for Immune Regulation in MS) (UK) (RRMS)

http://www.clinicaltrials.gov/ct2/show/NCT01470521

http://www.mssociety.org.uk/node/521080

25. Hydroxyurea (PPMS) (S. Andrea Hospital)

http://clinicaltrials.gov/ct2/show/NCT01103583

26. Idebenone (National Institute of Neurological Disorders and Stroke)

http://www.clinicaltrials.gov/ct2/show/NCT00950248

27. Interferon alpha (oral) (University of Texas-Houston)

http://www.mdpi.com/1424-8247/3/4/1108/pdf

http://www.ncbi.nlm.nih.gov/pubmed/16542137

http://neurology.uth.tmc.edu/faculty/bio-Staley-Brod.html

28. Lamotrigine (with Interferon Beta 1a) (Cantonal Hospital of St. Gallen, Switzerland)

http://clinicaltrials.gov/show/NCT00917839

29. Lipitor (aka atorvastatin) (Pfizer)

http://www.clinicaltrials.gov/ct2/show/NCT00818103

http://www.clinicaltrials.gov/ct2/show/NCT01111656

http://www.eurekalert.org/pub_releases/2010-04/uoc–sms041410.php

30. Lithium (US Department of Veterans Affairs)

http://www.clinicaltrials.gov/ct2/show/NCT01259388

31. LY2127399 (Anti-BAFF Human Antibody) (Eli Lilly)

http://www.clinicaltrials.gov/ct2/show/NCT00882999

32. Melatonin (Tehran University of Medical Sciences)

http://clinicaltrials.gov/show/NCT01279876

33. Mesenchymal Stem Cells (four phase II trials listed at clinicaltrials.gov, plus 1 in the UK)

http://www.clinicaltrials.gov/ct/show/NCT00395200

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

http://www.clinicaltrials.gov/ct2/show/NCT01056471

http://www.clinicaltrials.gov/ct2/show/NCT01228266

http://www.mssociety.org.uk/ms-news/2011/07/ms-society-funds-major-international-stem-cell-research

34. Methotrexate – intrathecal

http://www.ncbi.nlm.nih.gov/pubmed/20532907

http://www.prnewswire.com/news-releases/sixty-two-year-old-chemotherapy-treatment-shows-promising-results-on-progressive-multiple-sclerosis-patients-97304684.html

http://www.msrcny.org/research/published/safety-long-term-intrathecal-methotrexate-therapy-progressive-forms-multiple

http://www.neura.net/mylibrary/print.asp?src=1&id=494

35. Minocycline

http://www.clinicaltrials.gov/ct2/show/NCT01073813

http://www.abstracts2view.com/aan2007boston/view.php?nu=AAN07L_S02.003

36. MIS416 (trial for progressive MS) (Innate Therapeutics)

http://www.innateimmunotherapeutics.com/clinical-trials

http://www.innateimmunotherapeutics.com/article/9/2012/08/22/Innate-Announces-Interim-Results-from-Phase-2-Study-of-MIS416-in-Secondary-Progressive-Multiple-Sclerosis

37. Mycophenolate mofetil (aka Cellcept) (with Avonex)

http://www.clinicaltrials.gov/ct/show/NCT00324506

38. Myelin Peptides (epicutaneous immunisation) (Medical University of Lodz, Poland)

http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=115915&XNSPRACHE_ID=2&XNKONGRESS_ID=126&XNMASKEN_ID=900

39. MyeloXen (Xenetic Biosciences and Pharmsynthez)

http://en.pharmsynthez.com/Myeloxen.66.html

http://www.xeneticbio.com/uploads/xeneticmakesclinicalprogress.pdf

40. NeuroVax (Immune Response BioPharma)

http://www.immuneresponsebiopharma.com/Pages/DrugDiscovery.aspx

41. NT-KO-003 (Advancell and Neurotec Pharma)

http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=137138&XNSPRACHE_ID=2&XNKONGRESS_ID=150&XNMASKEN_ID=900

http://www.prnewswire.com/news-releases/start-of-in-patient-clinical-trials-with-nt-ko-003-the-first-neuroprotective-drug-for-multiple-sclerosis-without-immunosuppressive-effects-125807588.html

42. Ofatumumab (HuMax-CD20) (Genmab and Glaxosmithkline)

http://www.clinicaltrials.gov/ct2/show/NCT00640328

http://www.clinicaltrials.gov/ct2/show/NCT01457924

http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10098.htm

http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=118695&XNSPRACHE_ID=2&XNKONGRESS_ID=126&XNMASKEN_ID=900

43. Olesoxime (TRO19622) (Trophos)

http://www.trophos.com/research/pipeline.htm

http://www.trophos.com/news/pr20111025.htm

http://www.genengnews.com/gen-news-highlights/funds-awarded-for-clinical-trial-of-olesoxime-in-ms/81247464/

44. Omega-3 fatty acids (University of Washington)

http://www.clinicaltrials.gov/ct2/show/NCT01026272

http://www.nature.com/ncpneuro/journal/v5/n2/full/ncpneuro1009.html#B18

45. ONO-4641 (oral S1P receptor agonist) (Ono Pharmaceutical)

www.ono.co.jp/eng/news/pdf/sm_cn120417.pdf

http://www.clinicaltrials.gov/ct2/show/NCT01226745

http://www.clinicaltrials.gov/ct2/show/NCT01081782

http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=118663&XNSPRACHE_ID=2&XNKONGRESS_ID=126&XNMASKEN_ID=900

http://www.ono.co.jp/jp/ir_info/annual/pdf/2009/fi0911.pdf

46. Phenytoin (University College, London)

http://clinicaltrials.gov/ct2/show/NCT01451593

47. PI-2301 (Merck Serono)

www.merckserono.com/corp.merckserono_2011/en/images/20110916_en_tcm1494_80349.pdf?Version=

http://www.ncbi.nlm.nih.gov/pubmed/20466440

http://www.fiercebiotech.com/special-reports/2011-biotech-graveyard/peptimmune-2011-biotech-graveyard

48. Pixantrone (aka BBR 2778 ) (Cell Therapeutics)

http://www.nationalmssociety.org/research/clinical-trials/index.aspx

(“Clinical Trials in MS…” .pdf document)

49. Raltegravir (Isentress) (Queen Mary University of London)

http://clinicaltrials.gov/show/NCT01767701

http://multiple-sclerosis-research.blogspot.co.uk/2013/03/research-day-talk-charcot-project.html

50. Riluzole (with Avonex) (UCSF)

http://neurology.ucsf.edu/msc/research.htm#riluzole

http://www.clinicaltrials.gov/ct2/show/NCT00501943

51. RPI-78M (Nutra Pharma / ReceptoPharm)

http://www.receptopharm.com/drug_development/pipeline.php

52. RTL1000 (Artielle ImmunoTherapeutics)

http://www.reuters.com/article/pressRelease/idUS98713+14-Sep-2009+PRN20090914

http://www.artielle.com/drug-development/multiple-sclerosis.php

http://www.clinicaltrials.gov/ct/show/NCT00411723

53. Stem cell transplant from donor (allogeneic) (Duke University)

http://www.clinicaltrials.gov/ct2/show/NCT00849745

54. Tovaxin (aka Tcelna) (Opexa)

http://www.opexatherapeutics.com/?page=release&section=news&article=110411

http://www.opexatherapeutics.com/?page=release&section=news&article=091410

http://www.opexatherapeutics.com/?page=release&section=news&article=080510

55. Trimesta (oral) (estriol) (with copaxone) (Adeona Pharmaceuticals)

http://www.adeonapharma.com/pipeline.php?pageID=8

http://www.clinicaltrials.gov/ct/show/NCT00451204

56. Vitamin D3 (Johns Hopkins University, Carmel Medical Center, Merck, Charite University, University of Turku)

http://www.vitamindcouncil.org/clinical-trials-testing-vitamin-ds-effect-on-ms/

http://www.ncbi.nlm.nih.gov/pubmed/21620416

http://www.ncbi.nlm.nih.gov/pubmed/17823429

http://www.vitamindandms.org/clinicaltrial/clinicaltrial.html

http://www.clinicaltrials.gov/ct2/show/NCT01490502

http://www.clinicaltrials.gov/ct2/show/NCT01005095

http://www.clinicaltrials.gov/ct2/show/NCT01024777

http://www.clinicaltrials.gov/ct2/show/NCT01198132

http://www.clinicaltrials.gov/ct2/show/NCT01440062

http://www.clinicaltrials.gov/ct2/show/NCT01339676

http://www.clinicaltrials.gov/ct2/show/NCT01285401

57. Zocor (aka simvastatin) (RRMS and SPMS) (Merck Serono)

http://www.clinicaltrials.gov/ct/show/NCT00242268

http://www.clinicaltrials.gov/ct/show/NCT00429442

http://www.clinicaltrials.gov/ct2/show/NCT00647348

http://www.clinicaltrials.gov/ct2/show/NCT00261326

http://registration.akm.ch/einsicht.php?XNABSTRACT_ID=118672&XNSPRACHE_ID=2&XNKONGRESS_ID=126&XNMASKEN_ID=900

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