Higher dose of Copaxone in clinical trials

dignan · Family Elder Joined: Aug 12, 2004 Posts: 1186

I guess it's good news, just not as exciting as a treatment that might actually be a breakthrough. I'm not complaining though...and now there's something new to add to the phase III section of the list.

Teva Announces That Higher Dose of Copaxone Showed Increased Efficacy in Multiple Sclerosis (MS)

BUSINESS WIRE - April 5, 2006 - A new, higher dose of Copaxone (glatiramer acetate injection) showed promising results in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). A 9-month, randomized, double-blind, parallel-group phase II study of 90 patients comparing a 40 mg dose of Copaxone to the currently approved 20 mg dose showed a 38% greater reduction in mean cumulative number of gadolinium (Gd)-enhancing lesions as measured by magnetic resonance images (MRI) of the brain in patients taking the higher dose compared with those taking the 20 mg dose. In addition, patients taking Copaxone 40 mg experienced a reduced mean on-trial relapse rate of 77% when compared to annual relapse rate prior to entry, as compared to 62% with Copaxone 20 mg.

These study results were announced as a Late Breaking Science platform presentation at this year's 58th Annual Meeting of the American Academy of Neurology (AAN) in San Diego, CA, April 1-8, 2006.

"These results suggest that a 40 mg dose of Copaxone may provide even better control of disease activity within the central nervous system than the currently approved 20 mg dose," said Jeffrey A. Cohen, Director of the Experimental Therapeutics Program at the Cleveland Clinic's Mellen Center for MS Treatment and Research and Coordinating Principal Investigator of the study. "The higher dose showed promise in terms of providing additional treatment benefits to RRMS patients, paving the way for additional research on this increased therapeutic dose of Copaxone."

Data from this study demonstrated that Copaxone 40 mg was well-tolerated with a safety profile similar to the currently available 20 mg dose. The efficacy and safety of the approved 20 mg dose of Copaxone have been well established by three pivotal trials and over a decade of experience and clinical research.

"Following these results, we are planning to conduct a large-scale Phase III study designed to confirm the higher efficacy of Copaxone with the increased dose. The Phase III study is expected to be launched in the second half of 2006," said Israel Makov, President and Chief Executive Officer of Teva Pharmaceutical Industries Ltd. "This study is part of our strong clinical development program in MS - a program designed to help MS patients and improve their quality of life."

Study Design and Results

The study was a randomized, double-blind, parallel-group study conducted at 18 centers in the U.S. in 90 patients with RRMS. The study evaluated the effect of 40 mg of Copaxone versus 20 mg of Copaxone on disease activity as measured by MRI and clinical relapses, as well as the safety and tolerability of the 40 mg dose over a period of 9 months. Patients that qualified for this study had clinically-definite MS, had experienced a relapse in the previous year, had at least one Gd-enhancing lesion at screening visit, and had a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5. Patients were randomized in equal numbers to receive either 40 mg or 20 mg of Copaxone. All patients underwent an MRI at baseline, and then at months 3, 7, 8 and 9. Neurological examinations were performed at screening, baseline, and again at months 3, 6 and 9, and suspected on-trial relapses were confirmed at an unscheduled visit within 7 days. The difference between the two treatment arms was assessed using a Poisson regression model accounting for potential differences in study-site and in baseline gadolinium (Gd)-enhancing lesion counts.

Copaxone 40 mg showed a 38% greater reduction of inflammatory disease activity as measured by mean cumulative number of Gd-enhancing T1 MRI lesions versus Copaxone 20 mg (p=0.0898). The benefit of the 40 mg dose was observed in as soon as 3 months (p=0.005) through MRI measurement. When compared to baseline numbers, the risk of having MRI activity (Gd-enhancement) in the 40 mg group at months 7, 8 and 9 was reduced by 75% (p less than 0.0001), compared to 65% in patients receiving the 20 mg dose (p less than 0.0001).

Relapse rates were also lower in patients who received the 40 mg dose of Copaxone, when compared to those who received 20 mg dose (0.34 versus 0.57, respectively). Patients on 40 mg dose of Copaxone experienced a reduced on-trial mean relapse rate of 77% when compared to the annual relapse rate prior to entry, versus patients who received the 20 mg dose (62% reduction). The time to the first relapse was significantly delayed from 80 days in the 20 mg group to 213 days in the 40 mg group (p=0.0367).

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