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news.Cell therapies developer PharmaFrontiers has obtained encouraging interim results from two phase I/II open-label studies of Tovaxin in multiple sclerosis, indicating the treatment to be safe and well tolerated, with patients showing positive responses.
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Tovaxin is a trivalent formulation of attenuated myelin-peptide reactive T cells (MRTCs), which are derived from peripheral blood and produced ex vivo as myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG) reactive T cells.
An interim analysis of a phase I/II dose-escalation study of six evaluable patients, half of whom received a low dose and the other half received a mid dose during the six-month evaluable period, indicated that the Tovaxin therapy reduces peripheral blood MRTC levels in concert with improvements in disability scores Kurtzke Expanded Disability Status Scale (EDSS) as well as in disability neurological assessments for psychological scores Multiple Sclerosis 29 point Impact Scale (MSIS-29).
The exacerbation rate over the previous two years for the patients was 1.18 per year. Only one treated patient reported an exacerbation during the six-month evaluable period in this study. All of the related adverse events were mild or moderate in severity.
An interim analysis of a phase I/II extension study of nine evaluable patients, who received two doses during the six-month evaluable period, indicated a percentage reduction in MRTCs observed at three and six months for all three categories of MRTCs. A statistically significant percentage reduction in PLP T cells was observed at three and six months and there was a percentage reduction in MBP and MOG T cells at three and six months.
The exacerbation rate over the previous two years for the patients was 0.85 per year and there were no exacerbations during the six-month evaluable period in this study.
“We are very encouraged by these preliminary MRTC levels, which demonstrated a dose response and large mean percentage reductions from baseline at follow-up visits during the six-month period,” said David McWilliams, CEO of PharmaFrontiers. “Accordingly, we plan on beginning our phase IIb/III clinical trials by the end of 2005 or early 2006.”
“These data, combined with the strong safety profile of Tovaxin, should be welcome news to all MS patients and their families, especially in light of disappointing product news of this past year,” he added.