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Copaxone

Copaxone, manufactured by Teva Marion Partners, is the brand name for a synthetic chemical used to modify the course of multiple sclerosis. The generic name of Copaxone is Glatiramer Acetate which is often shortened to GA. In early trials of the drug, it was known as Copolymer-1 and Cop-1.

While not a cure, Copaxone 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. Copaxone has also been shown to limit the formation of new MS-related lesions in the central nervous system and to reduce brain atrophy.

Copaxone was licensed for the treatment of RRMS in the USA by the Federal Drugs Authority (FDA) in December 1996. It has been approved in Britain, Canada and most of Europe by the national drug regulation organisations.

Copaxone 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 Copaxone 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.

Copaxone 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.

Here is a table of clinical trials involving Copaxone:
 
Efficacy of Copaxone in Relapsing-Remitting Multiple Sclerosis
Trial Name Brief Description Results References
Placebo-controlled, pilot trial of Cop-1 (Copaxone) in RRMS 25 volunteers self-injected 20 mg of Cop-1 dissolved in 1 ml of saline daily for two years - 23 injected saline alone 6 of the placebo group (26%) and 14 of the Cop-1 group (56%) had no relapses. There were 62 relapses in the placebo group (average 2.7 per person) and 16 in the Cop 1 group(average 0.6) N Engl J Med 1987 Aug 13; 317(7) : 408-14
Copolymer 1 Multiple Sclerosis Study Group - phase III multicenter, double-blind placebo-controlled trial 251 volunteers with RRMS, 125 taking Cop-1 by daily subcutaneous injection for two years and 126 taking placebo.  1 to 11 month extension of the trial confirmed the safety profile Final 2-year relapse rate was 1.19 for patients receiving Cop-1 and 1.68 or those receiving placebo, a 29% reduction in favor of cop-1. Disability levels (EDSS) were also better in the Cop-1 group Neurology 1995 Jul; 45(7) : 1268-76

Neurology 1998 Mar; 50(3) : 701-8

Copolymer 1 Multiple Sclerosis Study Group - an extension to 6 years of the above study 208 chose to continue in an open-label study with all patients receiving active drug Mean annual relapse rate of the patients was 0.42. This rate has continued to drop and is 0.23 for the 6th year. Of the group taking Cop-1 for 5 or more years, 69.3% were neurologically unchanged or have improved from baseline by at least one EDSS step Mult Scler 2000 Aug; 6(4) : 255-66

Mult Scler 2001 Feb; 7(1) : 33-41

European/Canadian Glatiramer Acetate Study Group - a study of the effects on MRI-measured disease activity and burden in people with RRMS 9 month double-blind, placebo-controlled trial with 239 volunteers (119 taking Copaxone, 120 taking placebo). On average, people in the Copaxone group had 10.8 fewer new enhancing lesions than the placebo group. The Copaxone group also did better on other measures Ann Neurol 2001 Mar; 49(3) : 290-7
Comparative trials involving Copaxone
Trial Name Brief Description Results References
Open-label treatment trial to compare the effect of IFNb-1a (Avonex), IFNb-1b (Betaseron), and glatiramer acetate (Copaxone) on the relapse rate in RRMS 12 month (18 months of follow-up) prospective, non-randomized, open-label trial with 156 volunteers (33 no treatment, 40 Avonex, 41 Betaseron and 42 Copaxone Average relapses per year:
Copaxone - 0.49;
Betaseron 0.55;
Avonex - 0.81;
Untreated - 1.02.
The Avonex reduction was not statistically significant
Eur J Neurol 2001 Mar ; 8(2): 141-8

Mult Scler 2001 Dec; 7(6) : 349-53

Comparison of Copaxone and Betaferon (Betaseron) in people with MS : an open-label 2-year follow-up 58 people with RRMS divided into: 
(a) Copaxone 20 mg subcutaneously daily - 20 people
(b) Copaxone 20 mg alternate-days - 18 people
(c) Betaseron 8 MIU subcutaneously alternate days - 20 patients
All groups showed a reducton in relapse rate over 2 years:
(a) Copaxone daily 1.1
(b) Copaxone alternate day, 0.9
(c) Betaseron 1.2.

All 3 groups deteriorated on EDSS:
(a)Copaxone daily by 0.5 points
(b) Copaxone alternate by 0.4 points
(c) Betaseron by 0.2 points

J Neurol Sci 2002 May 15; 197(1-2) : 51-5
Efficacy of Copaxone in Chronic Progressive Multiple Sclerosis
Trial Name Brief Description Results References
A placebo-controlled, double-blind, randomized, two-center, pilot trial of Cop 1 in chronic progressive MS 106 volunteers. Major end point was progression on EDSS Overall results were not statistically significant though 2-year probabilities of progressing were of 20.4% for the Cop 1 group and 29.5% for placebo Neurology 1991 Apr; 41(4): 533-9
Efficacy of Copaxone in Primary Progressive Multiple Sclerosis
Trial Name Brief Description Results References
PROMISE Trial, a three-year study to determine the safety and efficacy of COPAXONE(R) in Primary Progressive MS 948 people at 59 clinical centers from the United States, Canada, United Kingdom, and France Trial not completed Teva Press Release (2001)

Wolinsky JS, PROMiSe Study Group; Neurology 2001; 56 Suppl 3 : A37879

More information about Copaxone including comparative information between the various disease modifying treatments for multiple sclerosis can be found by following these links:
ABC treatments

Links to other studies involving Copaxone (Glatiramer Acetate):
Brain 2001 Sep;124(Pt 9):1803-12
Neurology 2001 Aug 28;57(4):731-3
Neurology 2001 Mar 27;56(6):702-8
Proc Natl Acad Sci U S A 1992 Jan 1;89(1):137-41
Proc Natl Acad Sci U S A 1991 Nov 1;88(21):9528-32

Copaxone links:
NMSS - Glatiramer Acetate (Copaxone)
Copaxone.com - Manufacturer web site
RemedyFind.com - Copaxone (Glatiramer acetate)


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