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Rheumatoid arthritis: June 2011 : Due to start Phase 2b clinical trial in rheumatoid arthritis.<ref>
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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>


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>


==References==
==References==

Revision as of 13:53, 21 June 2011

Clazakizumab
Monoclonal antibody
Type?
SourceHumanized
TargetIL-6
Clinical data
Routes of
administration
infusion
ATC code
  • none
Legal status
Legal status
  • investigational
  (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

  1. ^ a b "Phase 2a study of ALD518 for treatment of non small cell lung cancer (NSCLC) symptoms". June 2010.
  2. ^ a b http://www.xconomy.com/seattle/2008/09/18/alder-sets-stage-for-showdown-with-roche-with-fast-follower-antibody-drug-strategy/
  3. ^ 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
  4. ^ 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"
  5. ^ 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
  6. ^ http://www.nature.com/scibx/journal/v3/n35/full/scibx.2010.1056.html Inflaming resistance to Tarceva. 2010
  7. ^ http://clinicaltrials.gov/ct2/show/NCT00867516
  8. ^ 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
  9. ^ http://www.xconomy.com/seattle/2010/03/19/innovation-northwest-wrapup-alder-tekmira-acucela-other-emerging-little-biotechs/ March 2010
  10. ^ "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.
  11. ^ "EULAR 2010 Do not miss" (PDF). 2010.
  12. ^ 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

See also