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Ipilimumab ?
Monoclonal antibody
Type whole antibody
Source human
Target CTLA-4
Identifiers
CAS number 477202-00-9
ATC code none
Chemical data
Formula C6742H9972N1732O2004S40 
Mol. mass 148634.914 g/mol
Therapeutic considerations
Pregnancy cat.  ?
Legal status

Ipilimumab (also known as MDX-010 or MDX-101) is a human monoclonal antibody being developed by Bristol-Myers Squibb and Medarex. It is intended to be used as a drug to activate the immune system. Ipilimumab is undergoing clinical trials for the treatment of melanoma.[1]

Mechanism of action

Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that is believed to play a critical role in regulating natural immune responses. The absence or presence of CTLA-4 can augment or suppress the immune system's T-cell response in fighting disease. Ipilimumab is designed to block the activity of CTLA-4, thereby sustaining an active immune response in its attack on cancer cells.

Clinical trials

As of October 2007 there are two fully human anti CTLA-4[2] monoclonal antibodies in advanced clinical trials. Ipilimumab, which is an IgG1 isotype, and Tremelimumab (from Pfizer) which is an IgG2 isotype.[3][4]

On December 10, 2007, Bristol-Myers Squibb and Medarex released the results of three studies on ipilimumab.[5] One of the three studies failed to meet its primary goal of shrinking tumors in at least 10.0% of the study's 155 patients. The three studies tested 487 patients with advanced skin cancer. Side effects are often considered acceptable risks for cancer drugs given the severity of the disease, and ipilimumab is no exception. The medication caused rashes, diarrhea and hepatitis in a number of the patients being tested. Despite the weaker-than-anticipated results, the companies are still planning to meet with regulatory agencies to discuss moving ahead with the medication. They hope to submit a filing to the U.S. Food and Drug Administration seeking approval in the first half of 2008. Since patients suffering from extremely serious diseases like melanoma have so few treatment options, the companies believe that even the marginal success rate will be appealing to some.

As of September 2008, Medarex is performing a Phase I/II dose escalation clinical trial of ipilimumab in metastatic hormone-refractory prostate cancer (HRPC). As of 2009, some of the patients with advanced prostate cancer had their tumors drastically shrink, promoting further trials.[6]

On 19 June 2009 the Mayo Clinic reported two prostate cancer patients involved in a Phase II study using MDX-010 therapy who had been told initially that their condition was inoperable but had their tumors shrunk by the drug such that operation was possible and are now cancer-free as a result. The study was headed by Dr. Eugene Kwon.[7]

This press report however has been criticized as being somewhat inaccurate and entirely premature. The clinical trials are still at an early stage and are being run alongside other treatments - which could be the real explanation for the tumor shrinkage.[8] It is far too early to say whether ipilimumab has made any difference at all.[9]

References

  1. ^ ClinicalTrials.gov NCT00094653
  2. ^ "CTLA-4 strategies: Abatacept / Belatacept". healthvalue.net. http://www.healthvalue.net/ctlaigenglish.html. Retrieved 2009-06-24. 
  3. ^ Tomillero A, Moral MA (October 2008). "Gateways to clinical trials". Methods Find Exp Clin Pharmacol 30 (8): 643–72. PMID 19088949. 
  4. ^ Poust J (December 2008). "Targeting metastatic melanoma". Am J Health Syst Pharm 65 (24 Suppl 9): S9–S15. doi:10.2146/ajhp080461. PMID 19052265. 
  5. ^ "Top-Line Data Available from Three Ipilimumab Pivotal Trials in Patients with Advanced Metastatic Melanoma". Medarex, Inc.. 2007-12-10. http://www.medarex.com/cgi-local/item.pl/20071210-1085876. Retrieved 2009-06-24. 
  6. ^ "'Surprise' prostate result probed". BBC News. 2009-06-19. http://news.bbc.co.uk/2/hi/health/8110103.stm. Retrieved 2009-06-24. 
  7. ^ "Mayo Researchers: Dramatic Outcomes in Prostate Cancer Study". Mayo Clinic. 2009-06-19. http://www.mayoclinic.org/news2009-rst/5318.html. Retrieved 2009-06-24. 
  8. ^ Boyles S (2009-06-19). "New Therapy May Fight Prostate Cancer". WebMD. http://www.webmd.com/prostate-cancer/news/20090619/new-therapy-may-fight-prostate-cancer. Retrieved 2009-06-24. 
  9. ^ Lowe D (2009-06-23). "Medarex, Ipilimumab, Prostate Cancer, And Reality. :". In the Pipeline. Corante. http://pipeline.corante.com/archives/2009/06/23/medarex_ipilimumab_prostate_cancer_and_reality.php. Retrieved 2009-06-24. 
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