Mitox and copaxone

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Mitox and copaxone

Postby bromley » Fri Sep 29, 2006 5:59 am

A combo treatment for aggressive RR. This is the same combo that is being trialled in the UK after good results reported earlier this year.

No mention of EDSS. But this doesn't seem to matter to researchers - it's the number of relapses, reduction in Gd enhancing lesions etc that's important! Then they can generate lots of statistical data and avoid the real question - did the patient get any better?

Very Active Multiple Sclerosis Patients Benefited from COPAXONE(R) Treatment Following Short-Term Induction with Mitoxantrone
Induction Regime Reduced MRI-Measured Disease Activity by 89% Which Was Sustained Throughout 15-Month Study.

A new study showed that very active patients who received COPAXONE® (glatiramer acetate injection) therapy alone following short-term induction treatment with mitoxantrone experienced an 89 percent greater reduction (P less than0.0001) compared to those receiving COPAXONE® alone, in Magnetic Resonance Imaging (MRI)-disease activity as measured by Gadolinium (Gd) enhancing lesions of the brain. This initial benefit achieved early on in the study was maintained over the entire 15-month study period. In addition, no adverse events outside of those associated with either treatment when used as monotherapy were observed.

These data were presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain.

"These new data represent a promising development in the scientific community's effort to identify additional effective treatment strategies for those patients who have particularly aggressive forms of RRMS, many of whom do not respond optimally to traditional disease modifying therapies," said Tim Vollmer, M.D., chairman, Division of Neurology, Barrow Neurological Institute at St. Joseph's Hospital and Medical Center and the primary investigator in this study. "By putting patients on COPAXONE® after a brief induction period with mitoxantrone, we were able to significantly reduce MRI-disease activity in the brain of active RRMS patients and to sustain this benefit throughout the study."

About the Study

This randomised, double-blind study looked at the safety, tolerability and efficacy of COPAXONE® (glatiramer acetate injection) used after short-term induction therapy with mitoxantrone versus COPAXONE® alone. Relapsing-remitting multiple sclerosis (RRMS) patients in this study (n=40) were randomised to receive either COPAXONE® for one year following three months of mitoxantrone (M-GA; n=21), or COPAXONE® alone for 15 months (GA; n=19). The study included patients aged 18-55, who had a Gd-enhancing lesion at the time of an initial screening MRI scan and an EDSS score of <=6.5. Patients entering the study were considered very active with a mean number of Gd-enhancing lesions of 3.75. Subsequent brain MRIs were performed at screening and months six, nine, 12 and 15.

Results showing a reduction of Gd-enhancing lesions in the M-GA patient cohort compared with the GA cohort were observed as early as six months into the trial (p less than 0.0001) and were maintained throughout the duration of the study (p = 0.0147). The efficacy demonstrated in the GA cohort increased over the entire 15-months trial; a 46 percent reduction in Gd-enhancing lesions was achieved at nine months and at month 15, patients demonstrated a 67 percent reduction compared to entry.

A relapse was experienced on average eight months prior to baseline in all study participants; after 15 months, the majority of these patients had not experienced a relapse. Patients who received COPAXONE® after mitoxantrone showed a trend in experiencing fewer relapses over the study period. Mean relapse rate during the study period was 0.16 in the M-GA group and 0.32 in the GA group, reflecting a 46 percent greater reduction in relapses in M-GA patients than of those that did not receive mitoxantrone (p=0.31). There was no difference in time to first relapse between the patient cohorts.

Within study participants, the most frequent adverse events (AEs) associated with the M-GA group were infection, nausea and vomiting, menstruation irregularities and alopecia, and were consistent with known effects of mitoxantrone therapy. Injection site erythema was the most common AE in the GA group.

"Mitoxantrone carries certain risks which limit its use to a maximum recommended lifetime dose. These difficulties make mitoxantrone an option that is generally reserved for only a small group of patients who have a poor disease prognosis or whose disease does not respond to first-line treatment," said Tim Vollmer, M.D., chairman, Division of Neurology, Barrow Neurological Institute at St. Joseph's Hospital and Medical Center and the primary investigator in this study. "When used after short-term induction with mitoxantrone, COPAXONE® minimised exposure to mitoxantrone while maintaining treatment effects ongoing, making it a viable treatment option for a broader proportion of the MS population."

Source: Teva Pharmaceutical Industries Ltd.
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