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This Is MS: Copaxone

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 Possible Method of Action for Copaxone Discovered

CopaxoneCopaxone, manufactured by Teva Pharmaceuticals, has long been an alternative for relapsing-remitting multiple sclerosis patients that do not want to take any of the interferon-class of medications such as Avonex, Rebif or Betaseron. While its efficacy has been shown in numerous clinical trials, its mode of action has always been somewhat of a mystery.

A new study sheds some light on what Copaxone might actually be doing to accomplish its beneficial effect. While the particulars of the research go far beyond the complexity any of us will care to delve into, or perhaps even understand, the basic finding are as follows:

  • Copaxone administration elevates a particular type of immune system cell
  • These cells are of the CD8+ class, known as the killer T cells for their ability to destroy infected cells
  • These killer cells, in the presence of Copaxone, regulate the immune system by killing another type of immune system cell known as CD4+
  • CD4+ cells are usually considered "helper" cells in that they do not actually kill other cells but "help" the rest of the immune system in doing so by, among other things, activating and directing the killer cells

Why the killing of CD4+ cells by CD8+ cells turns out to be a good thing is not quite clear. The immune system is exceedingly complex and any number of theories could be presented, such as that the particular "helper" cells that are killed were the ones directing the attack on the central nervous system. However, what can be deduced is that Copaxone has some immune-system modulating effect that is generally beneficial to MS'ers, and a rising number of at least this particular type of killer cell is not detrimental to an MS'er (at least overall)-- otherwise, Copaxone would have likewise had a negative effect on patients. For so many years, the mantra has been that boosting an MS'ers immune system would be a bad idea... as research continues to unfold the puzzle that is MS, it is become clear that that is not entirely the case.

Click 'read more' for the full abstract


Posted by Administrator on Tuesday, May 23 @ 04:55:20 EDT (4169 reads)
(Read More... | 4300 bytes more | Score: 4.3)

 News: New Study: Combination of Copaxone and Anti-Oxidant NAC

CopaxoneScientists initiated a new study today looking at the combination of Teva's Copaxone (glatiramer acetate) and the over-the-counter anti-oxidant supplement N-Acetylcysteine or NAC. The hypothesis is that the anti-oxidant properties will protect brain cells (the reasoning behind combination with Copaxone versus anything else is not exactly made clear, although Copaxone has been rumored to be neuroprotective as well).

This is interesting primarily because if it works, getting access to NAC is very easy (!), and also because it focuses on the critical neuroprotective aspect of MS intervention, whereas the majority of treatments focus specifically on immunomodulation (e.g., Tysabri). However, it is an open-label trial so placebo effect will be in full force, not to mention that the inclusion of Copaxone and a short 46-week duration will make differentiating NAC's results impossible, thereby rendering the all-too-common "Further studies are warranted" conclusion.

"A single-group, 46-week, open-label pilot study to explore the efficacy, tolerability and safety of the combination of two drugs — COPAXONE®...an approved drug for Relapsing Remitting form of Multiple Sclerosis and N-Acetylcysteine (NAC) — in 18 subjects with Relapsing Remitting Multiple Sclerosis (RRMS) is now underway...

Dr. Hyman Schipper, the lead investigating neurologist, has reason to believe that adding NAC to Copaxone may further slow disease progression and enhance the neuroprotective properties of Copaxone in MS subjects. The theory is that NAC will prevent brain iron deposition and oxidative stress.

“To date, most pre-clinical and clinical studies investigating therapies for MS have focused on the immune-mediated inflammatory stage of the disease. Far less attention has been paid to the management of the simultaneous, neurodegenerative phase of the illness, which is now believed to contribute significantly to irreversible brain tissue damage, clinical disability and brain atrophy in MS patients”, declares Dr. Hyman Schipper..."

Please click "read more" for the full release...


Posted by Administrator on Tuesday, February 22 @ 14:14:47 EST (3071 reads)
(Read More... | 4818 bytes more | News | Score: 3.66)

 Research: After 10 years, 91% of Copaxone Users Still Walk Unaided

CopaxoneFollowing on the heels of the research on long-term Betaseron use, this new study from Teva, makers of Copaxone, claims remarkable long-term treatment benefit.

Comparing people who used Copaxone continuously for 10 years versus those who quit after an average of 4.5 years, the 10 year Copaxone group had 91% still walking unaided versus 50% of the ex-Copaxone users. Another interesting stat shows that only 38% of the long-term Copaxone users demonstrated worsening of disability, versus 72% of those who had quit.

"Data presented at the 20th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Vienna, Austria, demonstrated that relapsing-remitting multiple sclerosis patients (RRMS) who remained on COPAXONE® (glatiramer acetate injection) therapy for an average of 10 years showed significantly less progression of disability when compared with patients who discontinued therapy...

'One of the most common questions I receive from my newly diagnosed MS patients is, 'Where am I going to be in 10 years, and am I going to be able to walk?' Long-term, prospectively controlled trials with MS therapies help address these questions. These data support the long-term clinical benefits, safety, and tolerability of COPAXONE® (glatiramer acetate injection) for an average of 10 years,' stated Kenneth P. Johnson, professor of neurology at the University of Maryland, director of the Maryland Center for MS, and lead investigator in the trial. 'The vast majority of COPAXONE®-treated patients did not reach the critical EDSS level of 6.0 when compared to those patients that withdrew from the long-term follow-up.'

Click "read more" for the full story...

Note: Please see commentary from community member Art for some very important counterpoints-- thanks Art!


Posted by Administrator on Monday, October 11 @ 23:34:07 EDT (2945 reads)
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 News: Teva updates on Copaxone and Laquinimod (oral MS therapy)

CopaxoneSometimes you find very interesting nuggets of information tucked into company's quarterly financial reports. In this case, Teva provided an update in theirs today on Copaxone sales, how they feel Copaxone will fare against Elan and Biogen's Antegren, and laquinimod-- an oral therapy for MS.

"...Copaxone has 30% of the US market for multiple sclerosis treatment, and Teva's emphasizes that it accounted for half of new prescriptions in the past year, indicating that sales of Copaxone will continue to grow and that its market share will continue to rise.

"We have three competitors trying to dwarf Copaxone, but it's a different drug from the others, and its sales are growing in line with the growth of the market," said Makov. "There's an ostensible threat from Biogen Idec and Elan Corp., which are planning to launch a new drug (Antegren), but we believe that Copaxone is the best product on the market, and will continue to increase its market share. Figures published the other day indicated that Copaxone is taking market share and closing the gap with the market leader. Copaxone increased its US market share to 30.8%, while Biogen's Avonex had 33.7%."

While Copaxone's market share is growing, Teva is also developing an oral treatment for multiple sclerosis. Two months ago, it reached an agreement with Sweden's Active Biotech to develop and market laquinimod, an oral treatment for multiple sclerosis.

Active Biotech successfully completed Phase II clinical trials for laquinimod, which is well tolerated and effective in suppressing development of active brain MRI lesions in relapsing multiple sclerosis. Teva intends to complete the clinical development program and will conduct Phase III studies, expected toward the end of the decade."

Click "read more" for the full Copaxone quarterly report...


Posted by Administrator on Wednesday, August 04 @ 11:33:57 EDT (2907 reads)
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 Copaxone Every Other Day

Copaxone

Copaxone is a very popular treatment for Relapsing Remitting MS. Being the only approved medication for RRMS that is not an interferon, it offers a less severe side effect profile. Unfortunately, it is also the only treatment that requires an injection every single day... or does it?

A recent study showedthat many Copaxone users, particularly women, experience lipoatrophy ("dents" around the injection sites). This has created a great deal of interest in the idea that maybe it is not necessary to do daily injections. Spawning this idea was the rumor that studies had been done on Copaxone showing that every other day injections are just as effective as every day. It is not a rumor...

In an effort to educate our community as much as possible, we have located and now published these two studies. Be forewarned, they are very small and the results are not necessarily statistically significant. That being said, they show that skipping a day is about as effective as every day dosing, and the side effects were reduced. Excerpts follow:

"The authors reported that results with alternate day therapy were not statistically different from those achieved with daily treatment, aside from a lower dropout rate with alternate day methods."

"The most common adverse events reported with glatiramer acetate were injection site reactions, which appeared to be more frequent with [every day] vs [every other day] dosing."

To read the full article, click here or just go to our download section under Copaxone.

To Teva's (the manufacturer of Copaxone) credit, if you call their patient services arm Shared Solutions and ask them for this information, they will send it to you. But they will remind you, rightfully so, that Copaxone has only been approved (and thus, can only be recommended) for every day dosing.

This is a serious point, and let's please be clear: we are not posting this so that you will feel confident in switching yourself away from daily injections-- if you choose to pursue that route, that is a decision that MUST be made with your doctor's consent and not by yourself. These are small studies and while promising, they do not rigorously prove that every other day is as effective as every day, and the very real possibility exists that one could do great harm to themselves by reducing their dosage. While This is MS is open to experimentation, taking risks on your mainline treatment without the participation of your doctor is NOT advised. Instead we recommend that you print this study out and take it with you on your next neuro visit.


Posted by Administrator on Friday, June 25 @ 03:28:15 EDT (3889 reads)
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 News: Copaxone Pre-filled Now Available in Europe

Copaxone

Teva just launched pre-mixed, pre-filled Copaxone in Europe... we suppose it is much more convenient than having to mix it oneself. However, the fact remains that it is still a daily injection-- and we suspect that attribute is where the main inconvenience comes from.

"Aventis and Teva Pharmaceutical Industries Ltd. today announced that the Multiple Sclerosis (MS) treatment COPAXONE® (glatiramer acetate injection) is now available also in Europe in a pre-filled, ready-to-use syringe (PFS). For physicians, nurses and pharmacists, compliance and adherence to treatment are among the most important factors in any therapy. With COPAXONE® PFS injection will be faster and more convenient. No mixing or preparation is required, and, fewer supplies are needed, ensuring increased accuracy, better compliance, and reduced risk of contamination...

'The new pre-filled syringe is about meeting patients' needs for a treatment that is convenient, consistent and complete,” said Israel Makov, President and CEO of Teva. "The COPAXONE® PFS offers important and improved benefits for patients who already use our product, and will increase COPAXONE®'s appeal to additional MS patients throughout Europe. This is another step towards making COPAXONE® the drug of choice for MS patients in the European market...'"

Click "read more" for the full story...

 


Posted by Administrator on Sunday, June 20 @ 06:20:50 EDT (1369 reads)
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 Research: Copaxone Possibly Effective for Primary Progressive MS

Copaxone

This study makes the suggestion that Copaxone could very well be useful as a treatment for Primary Progressive Multiple Sclerosis, particularly in men. However, there was a (strangely enough) low rate of progression in both the placebo and the drug groups, and so statistical significance was not reached. Still, this bodes well for PPMS'ers who until now really have had no sanctioned CRAB treatment choice (Novantrone is approved for PPMS, and anecdotally Low Dose Naltrexone has shown efficacy in this subgroup as well).

"Treatment with COPAXONE® (glatiramer acetate injection) may provide beneficial effects in patients with primary progressive multiple sclerosis (PPMS), according to new data presented late yesterday at the 56th Annual Meeting of the American Academy of Neurology. In a post-hoc analysis of all available data from the intention-to-treat cohort, men treated with COPAXONE® were found to have significantly slower rates of progression of the disease than those treated with placebo. No overall benefit was shown, a result that may have been driven by the low rate of progression in the study population. "

Click "read more" for the full article...


Posted by Administrator on Thursday, April 29 @ 20:36:03 EDT (3714 reads)
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 Research: 10 Year Copaxone Study Shows it is Remarkably Effective

Copaxone

This new study shows remarkable efficacy for Copaxone in a 10 year trial. Even so, take it with a grain of salt, as these long-term studies can easily be skewed (e.g., if someone was not doing well even on therapy and quit the drug, they look the same as someone who quit the drug and then began doing worse).

"Relapsing-remitting multiple sclerosis (RRMS) patients who remained on COPAXONE® (glatiramer acetate injection) therapy for an average of 10 years experienced significantly less progression of disability than patients who withdrew from the open-label, long-term follow-up study...

According to data presented late yesterday at the 56th annual meeting of the American Academy of Neurology, more than 90 percent of the 108 patients still on COPAXONE® did not show evidence of disease progression to an EDSS of 6.0 on the Expanded Disability Status Scale (EDSS). In comparison, 50 percent of the 47 patients who withdrew from COPAXONE® therapy after an average of 4.5 years progressed to this score."

Click "read more" for the full article-- if you're considering getting on Copaxone, this is a very important read.


Posted by Administrator on Thursday, April 29 @ 20:22:28 EDT (3239 reads)
(Read More... | 8963 bytes more | Research | Score: 2.5)

 Research: Copaxone Effective for Multiple Sclerosis

Copaxone

This study critically evaluates all the previous studies on Copaxone. The conclusion is that Copaxone is indeed an effective therapy for Multiple Sclerosis-- an important deduction considering that there is always some controversy bouncing around regarding Copaxone's efficacy, given that it is very different in its approach than the other proven treatments.

"Glatiramer acetate (Copaxone®, Teva Pharmaceuticals Ltd) is a collection of immunomodulatory, synthetic polypeptides indicated for the treatment of relapsing-remitting multiple sclerosis (RR MS)...

The efficacy of glatiramer acetate is stable or may increase over time and the drug has a favourable side effect profile. Glatiramer acetate is an appropriate first-line immunomodulatory therapy for RR MS."

Click "read more" for the full abstract...


Posted by Administrator on Sunday, April 25 @ 14:46:23 EDT (2655 reads)
(Read More... | 2821 bytes more | Research | Score: 4.25)

 FDA-Approved Drugs: Brain-protecting Protein Boosted by Multiple Sclerosis Drug

CopaxoneCopaxone, a drug used to treat multiple sclerosis, has been found to stimulate immune system cells to produce a brain-protecting protein.

Posted by Administrator on Friday, November 21 @ 18:32:48 EST (1891 reads)
(Read More... | 3049 bytes more | FDA-Approved Drugs | Score: 4.37)


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