Clazakizumab: Difference between revisions
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==Clinical trials== |
==Clinical trials== |
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===Cancer=== |
===Cancer=== |
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A phase I clinical trial showed ALD518 was well tolerated and could reverse [[Cancer-related fatigue|fatigue in cancer patients]].<ref>http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=32916 |
A phase I clinical trial showed ALD518 was well tolerated and could reverse [[Cancer-related fatigue|fatigue in cancer patients]].<ref>{{cite web |url=http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=32916 |title=A phase I, pharmacokinetic (PK), and preliminary efficacy assessment of ALD518, a humanized anti-IL-6 antibody, in patients with advanced cancer. |year=2009 }}</ref> |
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A phase II trial for advanced cancer is due to end in Oct 2009.<ref>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"</ref> Results due June 2010.<ref>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</ref> Results from 124 [[non-small cell lung cancer]] (NSCLC) patients were favourable (e.g. 1/10 the weight loss).<ref name=June2010>{{cite web|url=http://www.empr.com/phase-2a-study-of-ald518-for-treatment-of-non-small-cell-lung-cancer-nsclc-symptoms/article/171887/ |title=Phase 2a study of ALD518 for treatment of non small cell lung cancer (NSCLC) symptoms |date=June 2010 }}</ref> |
A phase II trial for advanced cancer is due to end in Oct 2009.<ref>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"</ref> Results due June 2010.<ref>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</ref> Results from 124 [[non-small cell lung cancer]] (NSCLC) patients were favourable (e.g. 1/10 the weight loss).<ref name=June2010>{{cite web|url=http://www.empr.com/phase-2a-study-of-ald518-for-treatment-of-non-small-cell-lung-cancer-nsclc-symptoms/article/171887/ |title=Phase 2a study of ALD518 for treatment of non small cell lung cancer (NSCLC) symptoms |date=June 2010 }}</ref> |
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Revision as of 13:56, 21 June 2011
| Monoclonal antibody | |
|---|---|
| Type | ? |
| Source | Humanized |
| Target | IL-6 |
| Clinical data | |
| Routes of administration | infusion |
| ATC code |
|
| Legal status | |
| Legal status |
|
| (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/
- ^ "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".
External links
See also
- Tocilizumab (Actemra) an anti-IL-6 receptor mAb
- Anti-IL-6, other anti-interleukin-6 agents
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