Clazakizumab: Difference between revisions
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June 2011 : Due to start Phase 2b clinical trial in rheumatoid arthritis.<ref>{{cite news |url=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 |title=Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis. Date=June 2011 }}</ref> |
June 2011 : Due to start Phase 2b clinical trial in rheumatoid arthritis.<ref>{{cite news |url=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 |title=Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis. Date=June 2011 }}</ref> |
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===Crohn's disease=== |
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A phase II trial for crohn's disease is due to run until 2015.<ref name=crohn2012>{{cite news |url=http://www.xconomy.com/seattle/2012/08/27/alder-gets-3-5m-milestone-as-bristol-myers-starts-crohns-study/ |title=Alder Gets $3.5M Milestone as Bristol-Myers Starts Crohn’s Study |date=27 Aug 2012 }}</ref> |
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==See also== |
==See also== |
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Revision as of 23:02, 3 September 2012
| Monoclonal antibody | |
|---|---|
| Type | ? |
| Source | Humanized |
| Target | IL-6 |
| Clinical data | |
| Routes of administration | infusion |
| ATC code |
|
| Legal status | |
| Legal status |
|
| Identifiers | |
| ChemSpider | |
| (verify) | |
BMS-945429 (formerly ALD518) 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]
Crohn's disease
A phase II trial for crohn's disease is due to run until 2015.[13]
See also
- Tocilizumab (Actemra) an anti-IL-6 receptor mAb
- Anti-IL-6, other anti-interleukin-6 agents
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/
- ^ "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
- ^ "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.
- ^ "Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis. Date=June 2011".
- ^ "Alder Gets $3.5M Milestone as Bristol-Myers Starts Crohn's Study". 27 Aug 2012.
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