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Copaxone

Glatiramer Acetate (GA; trademark Copaxone® by Teva Pharmaceutical Industries, Ltd.) is licensed in much of the world for relapsing-remitting multiple sclerosis. In early trials of the drug, it was known as Copolymer-1 and Cop-1. more...

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While not a cure, glatiramer acetate has been shown in clinical trials to reduce the average relapse rate in people with the relapsing-remitting (RRMS) form of the disease. That doesn't mean that it reduces the relapse rate for all the trial volunteers, just that averaged over the entire volunteer population, the relapse rate was reduced. Glatiramer has also been shown to limit the formation of new MS-related lesions in the central nervous system and to reduce brain atrophy.

Glatiramer was licensed for the treatment of RRMS in the USA by the Food and Drug Administration (FDA) in December 1996. It has been approved in Britain, Canada and most of Europe by the national drug regulation organisations.

Glatiramer is a random chain polymer of amino acids - Glutamic acid, Lysine, Alanine and Tyrosine (hence GLATiramer). It is synthesized in solution from these amino acids a ratio of approximately 5 parts Alanine to 3 of Lysine, 1.5 of Glutamic acid and 1 of Tyrosine using N-carboxyamino acid anhydrides. It was originally designed to mimic a protein in myelin, called myelin basic protein, with the intention of inducing EAE (an animal model of MS). Quite to the contrary, it was found to suppress the disease and as a result came to be trialed in human MS. For this reason, it was originally believed to act as a decoy by drawing the immune system's attack away from the myelin.

Nowadays, researchers are no longer at all sure how glatiramer works. The is some evidence that it converts the body's immune response from a Th1 type to a Th2 one, promotes suppressor T cells or acts as an altered peptide ligand.

The drug is self-administered by daily sub-cutaneous injections of 20 mg.

It is generally well tolerated. The most common problem that users experience are injection site reactions which include itching and inflammation. These reactions can be mitigated against by revolving the injection site, preparing it with ice and ensuring that the drug is at room temperature before injecting. Some users experience flushing, chest and joint pains, weakness, nausea, anxiety and muscle stiffness. These tend to resolve after about a quarter of an hour without special treatment.

Read more at Wikipedia.org


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Longest MS drug study shows copaxone benefits continue long term
From Real Living with Multiple Sclerosis, 1/1/01 by Hinson-Smith, Vicki

The 6-year preliminary results from a 10-year study shows that sustained use of the drug Copaxone (glatiramer acetate) significantly reduces the relapse rate and also delays disability in persons with relapsing-remitting MS. The study, published in the August issue of Multiple Sclerosis, is the longest evaluation to date of a licensed MS therapy.

The study is scheduled to continue until mid-2002, when participants will have been evaluated for 10 years. Of the 101 MS patients receiving daily injections of Copaxone throughout the past 6 years, 77 have had three or fewer relapses, while 26 have not had any relapses. On average, study participants experienced a 72% reduction in the annual relapse rate.

"The findings suggest that not only is Copaxone well tolerated, but that the longer a patient takes the drug, the better it works," said Kenneth Johnson, MD, professor and chairman of neurology at the University of Maryland School of Medicine in Baltimore and principal investigator of the multicenter trial. An important finding in the study was that Copaxone could be taken daily for years and be well tolerated--good news because managing relapsing-remitting MS requires long-term drug therapy. Dr. Johnson said patients' willingness to make injections of Copaxone a part of their daily routines is an important measure of the tolerability, safety, and personal benefit of this treatment.

An international, multicenter study to evaluate the oral use of Copaxone has just begun and will last for 13 months. The goal is to assess the effectiveness of an oral form of the drug compared with placebo.

Source: National Multiple Sclerosis Society

Advisory Board note: The results of this study nust be interpreted with caution.This group of patients represents a selected sample of all patients originally entered into the randomized, double-blind, placebo-controlled trial of Copaxone. Some patients who may not have responded as well to Copaxone may have dropped out of the study at an earlier point. In addition, patients in the long-term study, as well as their physicians, were aware that they were taking Copaxone, which creates potential bias. Nonetheless, the results of this study are encouraging.

Copyright Springhouse Corporation Jan 2001
Provided by ProQuest Information and Learning Company. All rights Reserved

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