Multiple sclerosis is a disease in which the body’s own immune system attacks the protective layer of myelin around nerve fibers, producing short circuits.

View full article here: http://www.mscare.org/cmsc/Informs-Glatiramer-Acetate-data.html

The treatment, glatiramer acetate, marketed as Copaxone, was tested in 16 countries among 481 patients with a telltale lesion in the central nervous system called clinically isolated syndrome.

The volunteers either received the drug or a dummy lookalike for up to three years.

Copaxone reduced the risk of developing “clinically definite” MS by 45 percent compared with a placebo.

In addition, the time it took for 25 percent of patients to develop the full-scale disease was more than doubled in the Copaxone group, at just under two years on average compared with just under one year in the placebo group.

Around a million people around the world are affected by MS, a degenerative disease in which the immune system attacks myeline, the fatty sheath that protects nerve fibres.

As a result, signals between nerve cells are delayed, disrupted or even blocked, rather like a poor connection in an electrical wire.

This causes worsening problems in coordination and balance, as well as blurred vision and slurred speech.

“This study establishes glatiramer acetate as an option for patients with clinically isolated syndrome who choose to start treatment early to improve control of the underlying disease process,” says the new paper.

The study was led by Giancarlo Comi, a professor of neurology at Milan’s Vita-Salute University in Italy.

Copaxone is currently approved for treating “relapsing-remitting” forms of MS.

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“This study showed that treatment with AVONEX leads to fewer injection site reactions which is an important factor in improving compliance. As the only once-weekly injection treatment, AVONEX offers people with relapsing MS an easy-to-use and highly effective treatment option,” said Dr. Karsten Beer, lead investigator for the study and private neurologist in Wil, Switzerland. “Convenience of an MS therapy is an important consideration for patients, as they do not want a therapy that will interfere with their daily lives.”

The Swiss MS Skin Project was designed to determine the frequency of injection site reactions, including skin necrosis and lipoatrophy, in patients taking AVONEX, Betaferon, Copaxone, or Rebif (ABCRs). These data are important as ISRs are thought to reduce treatment compliance among patients. The study enrolled nearly 500 patients on ABCRs for a minimum of two years (mean treatment duration of 5.9 years) and followed patients for a total of one year. Study findings include:
- At the first assessment, significantly fewer AVONEX patients experienced ISRs (13.4% vs 57.7% for Betaferon [p < .0001], 30.4% for Copaxone [p = 0.056], 67.9% for Rebif [p < 0.001]), necrosis (0.0% vs 5.7% for Betaferon [p = 0.0279],  0.0% for Copaxone [p = NS], 6.0% for Rebif [p = 0.0201]) and lipoatrophy (1.2 % vs 8.9% for Betaferon [p = 0.0210], 13.0% for Copaxone [p = 0.0322], 10.3% for Rebif [p = 0.0093]);
- No AVONEX patients missed a dose in the four weeks prior to first assessment due to ISRs (vs 5.7% for Betaferon [p = 0.44], 4.3% for Copaxone [p = NS], and 7.1% for Rebif [p = 0.011]). These percentages were statistically significant versus Betaferon and Rebif; and
- Significantly more patients remained on AVONEX over the one year trial (86.6% vs 79.7% for Betaferon, 60.9% for Copaxone, and 83.2% for Rebif [overall p = 0.0364]) than any other treatment.

View full post here: http://www.eurekalert.org/pub_releases/2009-09/msl-fis091009.php

The first large-scale “CombiRX” clinical trial testing the combined use of FDA-approved interferon beta-1a (Avonex®) and glatiramer acetate (Copaxone®) to treat relapsing-remitting MS has just received a $19-million renewal grant from the National Institutes of Health. This is the largest MS trial ever supported by the NIH, with a cumulative investment of more than $44 million. The long-term trial is led by principal investigator Fred Lublin, MD, (Corinne Goldsmith Dickinson Multiple Sclerosis Center at Mount Sinai School of Medicine, New York, NY).

The study is now fully enrolled, with more than 1,000 participants at 67 medical centers across the United States and Canada. Dr. Lublin is a member of the National Board of Directors of the National MS Society and the Society’s National Clinical Advisory Board and the New York City Chapter Clinical Advisory Committee.

Combination therapy is being compared to the use of either agent alone for 36 months. All participants are receiving at least one active medication and there is not a placebo-only treatment arm. Each of these treatments is approved by the U.S. Food and Drug Administration for the treatment of relapsing MS. A previous, smaller pilot trial of the combination therapy suggested it was safe and warranted further study.

An important ancillary study to this trial, the NIH-sponsored biomarker project, is examining genetic and other biological markers at baseline and at a minimum of one additional point during the study. The hope is that these biological markers will provide a means for identifying, in the future, those patients with more aggressive disease as well as those who respond or fail to respond to therapy. Such markers would have considerable value in the management of MS.

Read more about this study in its listing on clinicaltrials.gov.

Source
MS Society

View full article here: http://www.medicalnewstoday.com/articles/158396.php

JERUSALEM–New data presented today provided evidence that long-term treatment with COPAXONE^® (glatiramer acetate injection) may offer sustained protection from neuronal/axonal injury. This protective effect was reflected biologically by a significant increase in N-acetylaspartate (NAA), a specific marker of neuronal mitochondrial function, in treated versus non-treated relapsing-remitting multiple sclerosis (RRMS) patients. These six-year results augment previously published findings suggesting that treatment with COPAXONE^® may provide a neuroprotective effect in RRMS patients^{1, 2}.

The study, “Six-Year Prospective Multi-Voxel Brain MRS Study of Two Cohorts in RRMS To Examine the Effect of Glatiramer Acetate on Neuronal/Axonal Metabolic Injury,” is the largest (n=46) and longest study of its kind to date. In the study, patients taking COPAXONE^® for six years experienced an improvement in neuronal mitochodrial function, as quantified by an increase in neuronal NAA levels and evaluated by ¹H- Magnetic Resonance Spectroscopy (¹H-MRS). Decreased neuronal NAA levels are reflective of neuronal/axonal injury.

“The potential ability to prevent or repair brain tissue damage in RRMS patients is an important treatment consideration given the degenerative pathology of this life-long condition,” said Omar Khan, M.D., Professor of Neurology, Director, Multiple Sclerosis Center, Wayne State University and lead investigator of the study. “These data further substantiate our previous research into the potential neuroprotective effect of COPAXONE^®, as well as the use of NAA measures as a reliable marker for assessing a patient’s disease progression and response to treatment.”

Similar results were reported from a different study examining the effect of COPAXONE^® in Clinically Isolated Syndrome (CIS) patients. The study demonstrated patients who received COPAXONE^® improved in their cerebral neuroaxonal integrity relative to patients treated with placebo. Patients on placebo showed a decline in NAA consistent with that demonstrated in historical control studies.

About the Study

Forty-nine patients, divided into two cohorts of previously treatment-naïve RRMS patients, underwent serial brain ¹H-MRS scanning. Group 1 (n=22) included patients who started COPAXONE^® therapy at enrollment (n=18) and during the course of the study (n=4). Mean age, disease duration and Expanded Disability Status Scale (EDSS) were 43.5 years, 8.2 years and 2.77, respectively. Mean NAA/Cr at baseline was 1.97 + 0.24 and 2.20 + 0.16 (+11.6 percent) at year 6 (p<0.05). Group 2 (n=31) included patients who started GA therapy at enrollment. Mean age, disease duration and EDSS were 35.1 years, 5.8 years and 2.53, respectively. Mean NAA/Cr at baseline was 1.99 + 0.1 and 2.12 + 0.08 (+6.53 percent) at year 6 (p<0.05). Twelve untreated RRMS patients were also scanned for two years and showed a significant decline in NAA/Cr over the two years of follow-up. Additionally four untreated patients initiated COPAXONE^® during the course of the study and demonstrated considerable improvement in the mean NAA/Cr ratio, as well as clinical stability during total study observation. Finally, nine healthy volunteers were scanned annually for controls. Further analysis is ongoing. The study was in part supported by Teva Neuroscience.

Read full article here: http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090428005745&newsLang=en

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for COPAXONE® (glatiramer acetate injection) to include the treatment of patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis (MS).

The FDA’s approval follows a similar decision by the Medicines and Healthcare Products Regulatory Agency (MHRA) in February 2009 under which 24 EU member states have mutually recognized an expanded label for COPAXONE® to include the treatment of patients with clinically isolated syndrome (CIS) suggestive of MS.

Up to 85% of MS patients initially experience a single neurological event suggestive of MS, known as CIS, and it has been demonstrated that early treatment initiation delays conversion from CIS to clinically definite MS (CDMS). This expanded indication in the U.S. and Europe allows patients to begin treatment with COPAXONE® from the very early stages of the disease.

“COPAXONE®, the world’s leading MS disease modifying therapy, has demonstrated the ability to provide treatment benefits very early on, when patients present with a first clinical episode and have MRI features consistent with MS,” said Moshe Manor, Teva’s Vice President, Global Branded Products, “This milestone, along with the existing long-term safety and efficacy data, further position COPAXONE® as a cornerstone in MS treatment.”

The FDA granted approval after reviewing the results of the PreCISe study, which indicated time to development of a second exacerbation was significantly delayed in patients treated with COPAXONE® compared to placebo (Hazard Ratio = 0.55; 95% Confidence Interval 0.40 to 0.77; p=0.0005). The cumulative probability of developing the second attack during the three year study period was significantly lower in the COPAXONE® group versus the placebo group (24.7% vs. 42.9%).

COPAXONE® is the only RRMS treatment with prospective long-term data demonstrating 8 out of 10 patients adhering to therapy are still able to walk unassisted after 15 years of therapy and 22 years of disease duration.

An approval for an expanded label for COPAXONE® was also granted by the Australian Health Authority (Therapeutic Goods Administration, TGA) in December 2008.

About the PreCISe Study

The multinational, multi-center, prospective, double-blind, randomized, Phase III PreCISe study was conducted globally at 80 centers. It included a total of 481 patients presenting with a single clinical episode and MRI scans suggestive of MS over a period of up to three years. Patients included were those who had a unifocal disease manifestation (i.e., clinical evidence of a single lesion). Patients received either COPAXONE® 20mg/day or placebo as a subcutaneous injection and continued treatment for up to three years, unless a second exacerbation was experienced. Patients who experienced a second exacerbation continued the trial on active treatment for an additional two years. The primary efficacy outcome was time to development of second exacerbation.

COPAXONE® (glatiramer acetate injection) was also shown to be well tolerated in the PreCISe study, with 84 percent of patients completing the three-year study period; this supports the safety and tolerability seen in RRMS patients treated with COPAXONE®.

A pre-planned interim analysis was performed on data accumulated from 81 percent of the three-year placebo-controlled study exposure. The PreCISe study demonstrated that the 25th percentile of number of days to second exacerbation more than doubled by COPAXONE® from 336 days to 722 days (Hazard Ratio = 0.55; 95% Confidence Interval 0.40 to 0.77) compared with placebo.

Moreover, there was a significant reduction in the number of new T2 lesions and in the number of T1-enhancing lesions in the COPAXONE® arm compared to the placebo arm, both at year one and year two magnetic resonance imaging (MRI) scans.

About COPAXONE®

COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 51 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

See additional important information at http://www.copaxone.com/pi/index.html

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world’s leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.

View entire article at: http://www.medicalnewstoday.com/articles/141213.php