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Rheumatoid arthritis: ===Crohn's disease===
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===Crohn's disease===
===Crohn's disease===
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>
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>


==See also==
==See also==

Revision as of 23:02, 3 September 2012

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

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. ^ "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. ^ "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. ^ "Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis. Date=June 2011".
  13. ^ "Alder Gets $3.5M Milestone as Bristol-Myers Starts Crohn's Study". 27 Aug 2012.