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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>{{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>
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>


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://web.archive.org/web/20110708082411/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>


It may be trialled in a dual therapy with [[Tarceva]] owing to a likely synergy.<ref>http://www.nature.com/scibx/journal/v3/n35/full/scibx.2010.1056.html Inflaming resistance to Tarceva. 2010</ref>
It may be trialed in a dual therapy with [[Tarceva]] owing to a likely synergy.<ref>http://www.nature.com/scibx/journal/v3/n35/full/scibx.2010.1056.html Inflaming resistance to Tarceva. 2010</ref>
{{update-section|date=December 2015}}
{{update-section|date=December 2015}}


Revision as of 00:40, 27 January 2016

Clazakizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetIL6
Clinical data
Routes of
administration		infusion
ATC code
  • none
Legal status
Legal status
  • investigational
Identifiers
CAS Number
ChemSpider
  • none
Chemical and physical data
FormulaC6426H9972N1724O2032S42
Molar mass145.2 kDa g·mol−1

Clazakizumab (formerly ALD518 and BMS-945429)[1] is an aglycosylated, humanized monoclonal antibody against interleukin-6.[2] 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.[3]

It is made using yeast cells rather than the standard Chinese hamster ovary cells.[3]

Clinical trials

Cancer

A phase I clinical trial showed ALD518 was well tolerated and could reverse fatigue in cancer patients.[4]

A phase II trial for advanced cancer is due to end in Oct 2009.[5] Results due June 2010.[6] Results from 124 non-small cell lung cancer (NSCLC) patients were favourable (e.g. 1/10 the weight loss).[2]

It may be trialed in a dual therapy with Tarceva owing to a likely synergy.[7]

Rheumatoid arthritis

The Phase IIa trial for rheumatoid arthritis[8] has completed with promising results leading to a licensing deal allowing phase III trials.[9] The results are to be presented in June 2010 at the European League Against Rheumatism (EULAR) meeting in Rome.[10] [11] 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 .[12]

2011: A phase 2 trial reported good results in patients not responsive to methotrexate (MTX).[13]

Oct 2013 : A phase 2B clinical trial has met its primary endpoint (ACR20 response at 12 weeks).[1] Adalimumab with MTX was included as a comparison in the trial.[1]

2014 : A dose ranging phase 2B trial was running.[14]

Crohn's disease

A phase II trial for Crohn's disease initially due to run until 2015.[15] has been prematurely discontinued after having recruited 71 patients out of 288.[16]

See also

References

  1. ^ a b c Promising Phase IIb Data On Clazakizumab In Patients With Moderate-To-Severe Rheumatoid Arthritis To Be Presented At The 2013 Annual Meeting Of The American College Of Rheumatology
  2. ^ a b "Phase 2a study of ALD518 for treatment of non small cell lung cancer (NSCLC) symptoms". June 2010.
  3. ^ a b http://www.xconomy.com/seattle/2008/09/18/alder-sets-stage-for-showdown-with-roche-with-fast-follower-antibody-drug-strategy/
  4. ^ "A phase I, pharmacokinetic (PK), and preliminary efficacy assessment of ALD518, a humanized anti-IL-6 antibody, in patients with advanced cancer". 2009.
  5. ^ http://web.archive.org/web/20110708082411/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"
  6. ^ 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
  7. ^ http://www.nature.com/scibx/journal/v3/n35/full/scibx.2010.1056.html Inflaming resistance to Tarceva. 2010
  8. ^ http://clinicaltrials.gov/ct2/show/NCT00867516 Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis (ALD518-003)
  9. ^ "Bristol-Myers Squibb and Alder Biopharmaceuticals Enter Global Agreement on Rheumatoid Arthritis Biologic". 10 Nov 2009.
  10. ^ http://www.xconomy.com/seattle/2010/03/19/innovation-northwest-wrapup-alder-tekmira-acucela-other-emerging-little-biotechs/ March 2010
  11. ^ "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.
  12. ^ "EULAR 2010 Do not miss" (PDF). 2010.
  13. ^ "A phase II, double-blind, randomised, placebo-controlled study of BMS945429 (ALD518) in patients with rheumatoid arthritis with an inadequate response to methotrexate". 2012. doi:10.1136/annrheumdis-2011-200704. {{cite journal}}: Cite journal requires |journal= (help)
  14. ^ Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
  15. ^ "Alder Gets $3.5M Milestone as Bristol-Myers Starts Crohn's Study". 27 Aug 2012.
  16. ^ http://www.clinicaltrials.gov/ct2/show/study/NCT01545050?show_locs=Y

Further reading

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