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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/9264

Title: The results of two multicenter, open-label studies assessing efficacy, tolerability and safety of protiramer, a high molecular weight synthetic copolymeric mixture, in patients with relapsing-remitting multiple sclerosis
Authors: De Stefano, N.
Filippi, M.
Confavreux, C.
Vermersch, P.
Simu, M.
Sindic, C.
Hupperts, R.
Bajenaru, O.
Edan, G.
Grimaldi, L.
Marginean, I.
Medaer, Rob
Orefice, G.
Pascu, I.
Pelletier, J.
Sanders, E.
Scarpini, E.
Mancardi, G. L.
Issue Date: 2009
Citation: MULTIPLE SCLEROSIS, 15(2). p. 238-243
Abstract: Objective Two pilot studies were conducted to evaluate safety, tolerability, and efficacy of two doses of Protiramer (TV-5010) in patients with relapsing-remitting multiple sclerosis. Background Both glatiramer acetate and TV-5010 are synthetic copolymers comprised the same four amino acids in a defined molar ratio. TV-5010 has higher average molecular weight than Glatiramer acetate and might be hypothesized that glatiramoids with higher molecular weight might be more immunoreactive than lower molecular weight peptides, thus increasing therapeutic potential and allowing for less frequent dosing. Methods In the two separate studies, after a 10 week pretreatment period, TV-5010 was given subcutaneously once weekly at 15 mg and 30 mg for 36 weeks. The primary end point was a reduction in the number of magnetic resonance imaging active lesions (i.e., T1-weigthed gadolinium-enhancing and new T2-weighted lesions) between the pretreatment period and the end of study. Results Both TV-5010 doses were generally well tolerated. The treatment with TV-5010 at a dose of 15 mg/wk did not show any significant effect. In contrast, in patients treated with at a dose of 30 mg/wk, a significant reduction in the mean number of gadolinium-enhancing (-58.8%; P = 0.0013) and new T2-W (-50%; P = 0.0002) lesions was observed. However, a large decrease in the mean number of both gadolinium-enhancing (-55%) and new T2-W (-40%) lesions during the pretreatment period made difficult the interpretation of the efficacy assessments. Conclusions Further studies are needed to confirm these preliminary data on safety and efficacy of TV-5010 at a weekly dose of 30 mg. Multiple Sclerosis 2009; 15: 238-243. http://msj.sagepub.com
Notes: [De Stefano, N.] Univ Siena, Dept Neurol & Behav Sci, Neurol & Neurometabol Unit, I-53100 Siena, Italy. [Filippi, M.] Scientif Inst & Univ Osped San Raffaele, Dept Neurol, Neuroimaging Res Unit, Milan, Italy. [Confavreux, C.] Hop Neurolog Pierre Wertheimer, Hosp Civils Lyon, Serv Neurol A, Lyon, France. [Vermersch, P.] Hop Roger Salengro, CHU Lille, Neurol Clin, Lille, France. [Simu, M.; Bajenaru, O.] Univ Emergency Hosp Bucharest, Dept Neurol, Bucharest, Romania. [Sindic, C.] Clin Univ St Luc, Dept Neurol, B-1200 Brussels, Belgium. [Hupperts, R.] Univ Hosp Maastricht, Dept Neurol, Maastricht, Netherlands. [Edan, G.] Univ Hosp Pontchaillou, Dept Neurol, Rennes, France. [Grimaldi, L.] Fdn Ist San Raffaele G Giglio Cefalu, Neurol Unit, Palermo, Italy. [Marginean, I.] Cty Clin Hosp Cluj, Dept Neurol, Cluj Napoca, Romania. [Medaer, R.] Univ Hasselt, Dept Neurol, Diepenbeek, Belgium. [Orefice, G.] Univ Naples Federico 2, Dept Neurol Sci, Naples, Italy. [Pascu, I.] Cty Clin Hosp, Dept Neurol, Targu Mures, Romania. [Pelletier, J.] CHU Timone, Dept Neurol, Marseille 5, France. [Scarpini, E.] Univ Milan, Osped Maggiore Policlin, IRCCS, Dept Neurol, I-20122 Milan, Italy. [Mancardi, G. L.] Univ Genoa, Neurol Clin 2, Dept Neurosci Ophthalmol & Genet, Genoa, Italy.
URI: http://hdl.handle.net/1942/9264
DOI: 10.1177/1352458508098269
ISI #: 000262954500011
ISSN: 1352-4585
Category: A1
Type: Journal Contribution
Validation: ecoom, 2010
Appears in Collections: Research publications

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