BMS-945429

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BMS-945429 ?
Monoclonal antibody
Source Humanized
Target IL-6
Clinical data
Legal status investigational
Routes infusion
Identifiers
ATC code None
Chemical data
Formula ?
 N (what is this?)  (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[edit]

Cancer[edit]

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[edit]

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[edit]

A phase II trial for Crohn's disease initially due to run until 2015.[13] has been prematurely discontinued after having recruited 71 patients out of 288.[14]

See also[edit]

References[edit]

  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 Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis (ALD518-003)
  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.". 2010. 
  12. ^ "Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis.". June 2011. 
  13. ^ "Alder Gets $3.5M Milestone as Bristol-Myers Starts Crohn’s Study". 27 Aug 2012. 
  14. ^ http://www.clinicaltrials.gov/ct2/show/study/NCT01545050?show_locs=Y