Post by jeffs on May 1, 2005 4:48:19 GMT -5
Patients with very aggressive relapsing-remitting multiple sclerosis improved dramatically after being dosed with mitoxantrone (MX) and Copaxone.
Globes correspondent 17 Apr 05 15:11
Results from an independent evaluation of Teva's Copaxone (glatiramer acetate injection) have demonstrated long-term suppression of clinical and MRI activity in patients with very aggressive relapsing-remitting multiple sclerosis (RRMS). Data were presented in Miami Beach at the 57th Annual Meeting of the American Academy of Neurology.
Teva subsidiary Teva Neuroscience enrolled 40 patients in December 2004 for a multicenter North American study. Copaxone was given in an open-label manner as sequential combination therapy with mitoxantrone (MX), then continued as monotherapy for up to five years (average 33 months, range 10-60 months). This study showed that patients treated with the combination stabilized or improved, had significantly suppressed relapses, and exhibited no MRI evidence of new brain lesions.
Twenty-seven patients with early active RRMS were included in the independent study. Following induction therapy with MX alone, Copaxone was given in sequential combination with MX for three to seven months. The sequential combination dosing was standardized to five months for the final 17 patients entered, representing one or two pulses of MX. Patients then continued on long-term Copaxone monotherapy.
While on MX alone, six relapses occurred. Only two relapses occurred, four and 12 months, after initiation of Copaxone. After an average of 33 months (range 10-60) of Copaxone monotherapy, patients remained progression free, and, at the most recent follow-up, Expanded Disability Status Scale (EDSS) scores were stable or improved in all patients.
Teva stated that the results extend and confirm data from the first 10 patients of the study cohort, previously presented at the 20th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2004. For these 10 patients, no relapses were seen at an average of 30 months (range 19-36) after starting Copaxone monotherapy
Study investigator Dr. Michael Boggild of the Walton Centre, Liverpool, UK, stated, "Our significant findings are very encouraging for patients who have severe, active forms of RRMS. The results may reflect a synergistic effect of this combination. Mitoxantrone may be acting as a short-term immunosuppressant, further enhancing the effects of Copaxone in preventing inflammatory and neurodegenerative responses long-term. The unique mechanism of action of Copaxone and its ability to reprogram the T-cell response may make it a logical choice when combination therapy is needed for patients with particularly aggressive forms of disease. I'm encouraged that further ongoing studies may validate our results."
Copaxone is now approved in 43 countries worldwide, including the US, Canada, Mexico, Australia, Israel, and all the European countries.
Published by Globes [online], Israel business news - www.globes.co.il - on Sunday, April 17, 2005
Globes correspondent 17 Apr 05 15:11
Results from an independent evaluation of Teva's Copaxone (glatiramer acetate injection) have demonstrated long-term suppression of clinical and MRI activity in patients with very aggressive relapsing-remitting multiple sclerosis (RRMS). Data were presented in Miami Beach at the 57th Annual Meeting of the American Academy of Neurology.
Teva subsidiary Teva Neuroscience enrolled 40 patients in December 2004 for a multicenter North American study. Copaxone was given in an open-label manner as sequential combination therapy with mitoxantrone (MX), then continued as monotherapy for up to five years (average 33 months, range 10-60 months). This study showed that patients treated with the combination stabilized or improved, had significantly suppressed relapses, and exhibited no MRI evidence of new brain lesions.
Twenty-seven patients with early active RRMS were included in the independent study. Following induction therapy with MX alone, Copaxone was given in sequential combination with MX for three to seven months. The sequential combination dosing was standardized to five months for the final 17 patients entered, representing one or two pulses of MX. Patients then continued on long-term Copaxone monotherapy.
While on MX alone, six relapses occurred. Only two relapses occurred, four and 12 months, after initiation of Copaxone. After an average of 33 months (range 10-60) of Copaxone monotherapy, patients remained progression free, and, at the most recent follow-up, Expanded Disability Status Scale (EDSS) scores were stable or improved in all patients.
Teva stated that the results extend and confirm data from the first 10 patients of the study cohort, previously presented at the 20th Annual Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2004. For these 10 patients, no relapses were seen at an average of 30 months (range 19-36) after starting Copaxone monotherapy
Study investigator Dr. Michael Boggild of the Walton Centre, Liverpool, UK, stated, "Our significant findings are very encouraging for patients who have severe, active forms of RRMS. The results may reflect a synergistic effect of this combination. Mitoxantrone may be acting as a short-term immunosuppressant, further enhancing the effects of Copaxone in preventing inflammatory and neurodegenerative responses long-term. The unique mechanism of action of Copaxone and its ability to reprogram the T-cell response may make it a logical choice when combination therapy is needed for patients with particularly aggressive forms of disease. I'm encouraged that further ongoing studies may validate our results."
Copaxone is now approved in 43 countries worldwide, including the US, Canada, Mexico, Australia, Israel, and all the European countries.
Published by Globes [online], Israel business news - www.globes.co.il - on Sunday, April 17, 2005