Clazakizumab: Difference between revisions
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than MTX + placebo with a maximum ACR score, ([[ACR score for rheumatoid arthritis|ACR70]], i.e. >70% of joints improved), after 16 weeks .<ref>{{cite web |url=http://www.eular.org/myUploadData%5Cfiles%5CEMEUNET_Do_Not_Miss_EULAR_2010.pdf |title=EULAR 2010 Do not miss. |year=2010 }}</ref> |
than MTX + placebo with a maximum ACR score, ([[ACR score for rheumatoid arthritis|ACR70]], i.e. >70% of joints improved), after 16 weeks .<ref>{{cite web |url=http://www.eular.org/myUploadData%5Cfiles%5CEMEUNET_Do_Not_Miss_EULAR_2010.pdf |title=EULAR 2010 Do not miss. |year=2010 }}</ref> |
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June 2011 : Due to start Phase 2b clinical trial in rheumatoid arthritis.<ref>http://gamutnews.com/20110620/30031/alder-biopharmaceuticals-to-receive-15-million-milestone-payment-from-bristol-myers-squibb-for-initiation-of-phase-2b-clinical-trial-in-rheumatoid-arthritis-of-ald518bms-945429-antibody-therapeutic.html</ref> |
June 2011 : Due to start Phase 2b clinical trial in rheumatoid arthritis.<ref>http://gamutnews.com/20110620/30031/alder-biopharmaceuticals-to-receive-15-million-milestone-payment-from-bristol-myers-squibb-for-initiation-of-phase-2b-clinical-trial-in-rheumatoid-arthritis-of-ald518bms-945429-antibody-therapeutic.html Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis. June 2011</ref> |
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==References== |
==References== |
Revision as of 13:53, 21 June 2011
Monoclonal antibody | |
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Type | ? |
Source | Humanized |
Target | IL-6 |
Clinical data | |
Routes of administration | infusion |
ATC code |
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Legal status | |
Legal status |
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(verify) |
ALD518 (now BMS-945429) is an aglycosylated, humanized monoclonal antibody against interleukin-6.[1] It is an investigational drug for cancer and rheumatoid arthritis due to its anti-inflammatory properties.
The relatively long half life of about 30 days should allow less frequent and subcutaneous injections.[2]
It is made using yeast cells rather than the standard Chinese hamster ovary cells.[2]
Clinical trials
Cancer
A phase I clinical trial showed ALD518 was well tolerated and could reverse fatigue in cancer patients.[3]
A phase II trial for advanced cancer is due to end in Oct 2009.[4] Results due June 2010.[5] Results from 124 non-small cell lung cancer (NSCLC) patients were favourable (e.g. 1/10 the weight loss).[1]
It may be trialled in a dual therapy with Tarceva owing to a likely synergy.[6]
Rheumatoid arthritis
The Phase IIa trial for rheumatoid arthritis[7] has completed with promising results leading to a licencing deal allowing phase III trials.[8] The results are to be presented in June 2010 at the European League Against Rheumatism (EULAR) meeting in Rome.[9] [10] Results showed that ALD518 in addition to MTX performs markedly better than MTX + placebo with a maximum ACR score, (ACR70, i.e. >70% of joints improved), after 16 weeks .[11]
June 2011 : Due to start Phase 2b clinical trial in rheumatoid arthritis.[12]
References
- ^ a b "Phase 2a study of ALD518 for treatment of non small cell lung cancer (NSCLC) symptoms". June 2010.
- ^ a b http://www.xconomy.com/seattle/2008/09/18/alder-sets-stage-for-showdown-with-roche-with-fast-follower-antibody-drug-strategy/
- ^ http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=32916 "A phase I, pharmacokinetic (PK), and preliminary efficacy assessment of ALD518, a humanized anti-IL-6 antibody, in patients with advanced cancer." 2009
- ^ http://www.boliven.com/clinical_trial/NCT00866970 Phase II: "Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-Related Fatigue and Cachexia"
- ^ http://www.xconomy.com/seattle/2010/05/13/alder-seeks-to-treat-cancer-patients-in-a-radical-way-fighting-inflammation-not-tumors/?single_page=true
- ^ http://www.nature.com/scibx/journal/v3/n35/full/scibx.2010.1056.html Inflaming resistance to Tarceva. 2010
- ^ http://clinicaltrials.gov/ct2/show/NCT00867516
- ^ http://www.smartbrief.com/news/aanp/industryBW-detail.jsp?id=9279E59B-9E2A-4823-9476-17782B175A34 "Bristol-Myers Squibb and Alder Biopharmaceuticals Enter Global Agreement on Rheumatoid Arthritis Biologic" 10 Nov 2009
- ^ http://www.xconomy.com/seattle/2010/03/19/innovation-northwest-wrapup-alder-tekmira-acucela-other-emerging-little-biotechs/ March 2010
- ^ "New Data for Investigational Antibody Blocking IL-6 in Rheumatoid Arthritis Patients to be Presented at Annual Congress of European League Against Rheumatism". June 2010.
- ^ "EULAR 2010 Do not miss" (PDF). 2010.
- ^ http://gamutnews.com/20110620/30031/alder-biopharmaceuticals-to-receive-15-million-milestone-payment-from-bristol-myers-squibb-for-initiation-of-phase-2b-clinical-trial-in-rheumatoid-arthritis-of-ald518bms-945429-antibody-therapeutic.html Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis. June 2011
External links
See also
- Tocilizumab (Actemra) an anti-IL-6 receptor mAb
- Anti-IL-6, other anti-interleukin-6 agents