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Last updated: 11 Aug 2015

ATX-MS-1467

Summary
Class: 
Immunomodulator
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Target: 
Major histocompatibility complex class II
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
T cell responses to myelin basic protein
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Status for MS: 
Phase IIa study is in progress (2014)
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Administration: 
Intradermal
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Subcutaneous
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Commercial: 
Is being developed by Apitope (responsible for all Phase I development) in collaboration with Merck Serono (responsible beginning with Phase II studies)
(4)
Apitope starts new clinical trial of its investigational Multiple Sclerosis treatment
Apitope, 18 May 2010
Accessed on 6 Oct 2014 from http://apitope.com/apitope-starts-new-clinical-trial-investigational-multiple-sclerosis-treatment/.
Phase I study was sponsored by Apitope Technology (Bristol) Ltd. (completed as of August, 2013)
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Phase II study is being sponsored by Merck KGaA (ongoing as of June, 2014)
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Names
Name: 
ATX-MS-1467
Synonyms: 
M2736
(10)
Apitope Announces Completion of Enrolment in Phase IIA Clinical Trial of ATX-MS-1467 in Relapsing Multiple Sclerosis
Apitope, 6 Aug 2015
Accessed on 11 Aug 2015 from http://apitope.com/apitope-announces-completion-of-enrolment-in-phase-iia-clinical-trial-of-atx-ms-1467-in-relapsing-multiple-sclerosis/.
Physiology
Class: 
Immunomodulator
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Target: 
Major histocompatibility complex class II
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
T cell responses to myelin basic protein
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Properties: 
Is a peptide vaccine
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Consists of equal parts of 4 synthetic, soluble peptides derived from human myelin basic protein
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Peptides that make up the vaccine represent immunodominant disease-associated myelin basic protein epitopes in individuals with MS with certain human leukocyte antigen haplotypes (DRB1*1501 and DQB1*0602)
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Targets major histocompatibility complex class II
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.

Mechanisms/Effects

Human: 
Based on the idea that vaccination with fragments of an MS autoantigen, myelin basic protein, will result in tolerance to those antigens in a process involving negative feedback control of the autoimmune reaction
(7)
Immunology: A tolerant approach.
Garber K
Nature. 2014 Mar 27; 507(7493):418-20. PMID: 24670744. Abstract
(8)
Negative feedback control of the autoimmune response through antigen-induced differentiation of IL-10-secreting Th1 cells.
Gabrysová L, Nicolson KS, Streeter HB, Verhagen J, Sabatos-Peyton CA, Morgan DJ, Wraith DC
J Exp Med. 2009 Aug 3; 206(8):1755-67. Epub 2009 Jul 27. PMID: 19635862. Abstract
Reduces T cell proliferation induced by myelin basic protein
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Animal: 
Promotes the re-establishment of self-tolerance to myelin peptides from the central nervous system in experimental autoimmune encephalomyelitis models
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Delays the onset and reduces the severity of experimental autoimmune encephalomyelitis (EAE) when given before EAE is induced in Lewis rats
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Halts the progression of experimental autoimmune encephalomyelitis when given either therapeutically or at onset of disease in double-transgenic mice that express human leukocyte antigen DR15 and human myelin basic protein-specific T cell receptor
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Reduces neurological deficits to a greater extent than myelin basic protein [82-98] or glatiramer acetate in an experimental autoimmune encephalomyelitis model
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Reduces infiltration of the brain by CD4+, CD8+ T cells, B cells, and activated macrophages, and reduces microglial activation, in experimental autoimmune encephalomyelitis double-transgenic mice (which express human leukocyte antigen DR15 and human myelin basic protein-specific T cell receptor)
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Increases interleukin 10 (IL-10) levels and reduces IL-17, IL-2, and tumor necrosis factor-alpha levels in experimental autoimmune encephalomyelitis double-transgenic mice (which express human leukocyte antigen DR15 and human myelin basic protein-specific T cell receptor)
(3)
ATX-MS-1467, An Immunotolerizing Agent, Halts Disease Progression and Reduces CNS Inflammation in Rodent Models of Multiple Sclerosis (P1.216)
Dellovade T, Rudin S, Zozulya A, Tomkinson B
Accessed on 6 Oct 2014 from http://www.neurology.org/content/82/10_Supplement/P1.216.
Inhibits experimental autoimmune encephalomyelitis in a dose-dependent manner in a humanized mouse model [(Ob x DR2)F1], which expresses MS-associated histocompatibility antigen HLA-DR2b as well as a human T-cell receptor specific for a DR2b-bound peptide from myelin basic protein
(9)
Preclinical development and first-in-human study of ATX-MS-1467 for immunotherapy of MS.
Streeter HB, Rigden R, Martin KF, Scolding NJ, Wraith DC
Neurol Neuroimmunol Neuroinflamm. 2015 Jun; 2(3):e93. Epub 2015 Mar 12. PMID: 25798453. Abstract
Inhibits experimental autoimmune encephalomyelitis in a humanized mouse model when given either before or after the onset of disease
(9)
Preclinical development and first-in-human study of ATX-MS-1467 for immunotherapy of MS.
Streeter HB, Rigden R, Martin KF, Scolding NJ, Wraith DC
Neurol Neuroimmunol Neuroinflamm. 2015 Jun; 2(3):e93. Epub 2015 Mar 12. PMID: 25798453. Abstract
Inhibits experimental autoimmune encephalomyelitis (EAE) when given after disease onset in a humanized mouse model, reducing the mean maximum EAE score as well as the duration of disease, whereas glatiramer acetate does not affect either of these measures
(9)
Preclinical development and first-in-human study of ATX-MS-1467 for immunotherapy of MS.
Streeter HB, Rigden R, Martin KF, Scolding NJ, Wraith DC
Neurol Neuroimmunol Neuroinflamm. 2015 Jun; 2(3):e93. Epub 2015 Mar 12. PMID: 25798453. Abstract
Regulatory and Commercial Status
Status for MS: 
Phase IIa study is in progress (2014)
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Highest status achieved (for any condition): 
Phase IIa
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Administration: 
Intradermal
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Subcutaneous
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Negative effects: 
Found to be safe and well-tolerated in a Phase I/IIa study
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Commercial: 
Is being developed by Apitope (responsible for all Phase I development) in collaboration with Merck Serono (responsible beginning with Phase II studies)
(4)
Apitope starts new clinical trial of its investigational Multiple Sclerosis treatment
Apitope, 18 May 2010
Accessed on 6 Oct 2014 from http://apitope.com/apitope-starts-new-clinical-trial-investigational-multiple-sclerosis-treatment/.
Phase I study was sponsored by Apitope Technology (Bristol) Ltd. (completed as of August, 2013)
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Phase II study is being sponsored by Merck KGaA (ongoing as of June, 2014)
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Key Clinical Trials
Placebo-controlled Trials: 
Head-to-Head Trials: 
Other Trials: 
Trial name: 
ATX-MS-1467 in Multiple Sclerosis (ongoing as of 2014)
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Phase: 
Phase IIa study
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Study Design: 
Industry-sponsored, multicenter, open-label, single-arm, proof-of-concept, baseline-controlled study to examine the effects of ATX-MS-1467, given using a dose-titration regimen for 4 weeks, followed by treatment for 16 weeks and then observation for 16 weeks, with the primary outcome measure the change in the average number of T1 contrast-enhanced lesions at weeks 12, 16, and 20 versus the average number at baseline (weeks -8, -4, and 0)
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Disease Stage: 
Relapsing MS
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Enrollment/Number of Patients: 
19 (estimated)
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Duration: 
36 weeks
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
Status/Outcome: 
Study start date, February 2014; estimated study completion date, June 2016 (final date for data collection for primary outcome measure)
(2)
ATX-MS-1467 in Multiple Sclerosis
ClinicalTrials.gov, 17 Jun 2014
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01973491.
; enrollment has been completed (6 August 2015)
(10)
Apitope Announces Completion of Enrolment in Phase IIA Clinical Trial of ATX-MS-1467 in Relapsing Multiple Sclerosis
Apitope, 6 Aug 2015
Accessed on 11 Aug 2015 from http://apitope.com/apitope-announces-completion-of-enrolment-in-phase-iia-clinical-trial-of-atx-ms-1467-in-relapsing-multiple-sclerosis/.
Trial name: 
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis (completed as of August, 2013; press release, September 2013)
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
(6)
Apitope Announces Positive Results from Clinical Trial of ATX-MS-1467 in Relapsing Multiple Sclerosis
Apitope, 3 Sep 2013
Accessed on 6 Oct 2014 from http://apitope.com/apitope-announces-positive-results-clinical-trial-atx-ms-1467-relapsing-multiple-sclerosis/.
Phase: 
Phase I study
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Study Design: 
Industry-sponsored, open-label, non-randomized, single-group assignment study to evaluate the safety and activity of ATX-MS-1467, given either intradermally or subcutaneously in an upward dose titration, with the drug given 9 times, 2 weeks apart, after which there was a 22-week followup period; adverse events (primary outcome measure) and effect on brain lesions (a secondary outcome measure) were monitored
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Disease Stage: 
RRMS
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Enrollment/Number of Patients: 
42
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Duration: 
48 weeks
(1)
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov, 17 Aug 2013
Accessed on 6 Oct 2014 from http://clinicaltrials.gov/ct2/show/NCT01097668.
Status/Outcome: 
ATX-MS-1467 was well tolerated; intradermal (but not subcutaneous) delivery of the drug was associated with a decrease in the number of contrast-enhancing brain lesions
(6)
Apitope Announces Positive Results from Clinical Trial of ATX-MS-1467 in Relapsing Multiple Sclerosis
Apitope, 3 Sep 2013
Accessed on 6 Oct 2014 from http://apitope.com/apitope-announces-positive-results-clinical-trial-atx-ms-1467-relapsing-multiple-sclerosis/.
Trial name: 
ATX-MS-1467 in SPMS (final results announced January, 2008; publ June, 2015)
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
(9)
Preclinical development and first-in-human study of ATX-MS-1467 for immunotherapy of MS.
Streeter HB, Rigden R, Martin KF, Scolding NJ, Wraith DC
Neurol Neuroimmunol Neuroinflamm. 2015 Jun; 2(3):e93. Epub 2015 Mar 12. PMID: 25798453. Abstract
Phase: 
Phase I/IIa study
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Study Design: 
Industry-sponsored, open-label, dose-escalation study to examine the safety and tolerability of ATX-MS-1467; doses of 25, 50, 100, 400, and 800 microg, followed by another 800 microg dose, were given 7 to 14 days apart
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
; participants expressed a variety of HLA-DR alleles (DRB1*01, DRB1*04, DRB1*07, DRB1*11, DRB1*13, DRB1*14, and DRB1*15)
(9)
Preclinical development and first-in-human study of ATX-MS-1467 for immunotherapy of MS.
Streeter HB, Rigden R, Martin KF, Scolding NJ, Wraith DC
Neurol Neuroimmunol Neuroinflamm. 2015 Jun; 2(3):e93. Epub 2015 Mar 12. PMID: 25798453. Abstract
Disease Stage: 
SPMS
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Enrollment/Number of Patients: 
6
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
Status/Outcome: 
ATX-MS-1467 was found to be safe and well tolerated and was associated with a reduction in T cell proliferation induced by myelin basic protein (whereas T cell responses to a different vaccine constitutent were unchanged); two of the six participants may have exhibited a positive clinical response to the drug (with one individual with optic neuritis resulting from MS showing improvements in vision that continued after treatment ended and another showing reductions in brain neuroinflammation as measured by MRI)
(5)
ATX-MS-1467 - Positive Immunological data in Multiple Sclerosis: Final Phase I/IIa data shows safety and tolerability, plus efficacy
Apitope, 30 Jan 2008
Accessed on 6 Oct 2014 from http://hugin.info/138779/R/1186287/237694.pdf.
References
DOI: 
doi/10.7493/msdf.10.14243.1