PharmaFrontiers: coming to TERMS with MS
10th March 2006
By Staff Writer
PharmaFrontiers is to conduct a new phase II trial for its MS vaccine candidate.
Following promising results from previous studies, PharmaFrontiers is to begin a new phase II trial of multiple sclerosis vaccine Tovaxin. The FDA panel's recent vote to re-launch Biogen Idec and Elan's Tysabri could bring relief to many multiple sclerosis sufferers. However, additional - and better - treatments are still much needed and PharmaFrontiers' trial is a step towards meeting that need.
Despite the potential re-launch of Tysabri, the multiple sclerosis (MS) market remains underserved. Not only are current MS drugs few in number - Tysabri's re-launch would make it only the sixth MS treatment currently available in the US - but they also have limited efficacy. There is, therefore, clear potential for additional, better treatments.
PharmaFrontiers' 'personalized' vaccine Tovaxin uses the individual patient's T-cells, which are grown in the lab before being rendered unable to replicate. These inactivated T-cells are then administered in a series of injections in order to stimulate protective immune responses. It is hoped that the immune system will then recognize these cells as intact and set about attacking them - also removing the healthy, problematic T-cells in the process.
PharmaFrontiers aims to begin a phase IIb US trial of Tovaxin in patients with clinically isolated syndrome (CIS) and relapse-remitting MS (RR-MS), the most common presenting form of MS, in April.
Earlier open-label phase I/II clinical trials have shown the treatment to be safe, well tolerated and highly efficacious. The annual relapse rate for one group of patients was reduced by an impressive 92%. Furthermore, the treatment appears to lower the autoimmune myelin-reactive T-cells (MRTCs) in patients' blood and improve patients' clinical measures
The phase IIb trial, named TERMS, will assess the drug's impact in 100 patients over 52 weeks, with the primary outcome measure being reduction in the number of MS lesions. Successful completion of this trial could pave the way for a phase III pivotal trial to begin in mid-to-late 2007.
PharmaFrontiers is aiming to position Tovaxin as a first-line therapy for MS and, if the results seen to date can be replicated in TERMS and subsequent trials, this could be achieved, granting MS sufferers a much-needed ray of hope. Moreover, although several previous attempts at developing a successful MS vaccine have failed, if Tovaxin were to outshine its ill-fated predecessors and reach the market, it could also offer more convenient dosing than its rivals, giving it a promising competitive edge.
http://www.pharmaceutical-business-review.com/article_feature.asp?guid=7C84E38E-CC9B-4A83-B092-83D84E8128CC
By Staff Writer
PharmaFrontiers is to conduct a new phase II trial for its MS vaccine candidate.
Following promising results from previous studies, PharmaFrontiers is to begin a new phase II trial of multiple sclerosis vaccine Tovaxin. The FDA panel's recent vote to re-launch Biogen Idec and Elan's Tysabri could bring relief to many multiple sclerosis sufferers. However, additional - and better - treatments are still much needed and PharmaFrontiers' trial is a step towards meeting that need.
Despite the potential re-launch of Tysabri, the multiple sclerosis (MS) market remains underserved. Not only are current MS drugs few in number - Tysabri's re-launch would make it only the sixth MS treatment currently available in the US - but they also have limited efficacy. There is, therefore, clear potential for additional, better treatments.
PharmaFrontiers' 'personalized' vaccine Tovaxin uses the individual patient's T-cells, which are grown in the lab before being rendered unable to replicate. These inactivated T-cells are then administered in a series of injections in order to stimulate protective immune responses. It is hoped that the immune system will then recognize these cells as intact and set about attacking them - also removing the healthy, problematic T-cells in the process.
PharmaFrontiers aims to begin a phase IIb US trial of Tovaxin in patients with clinically isolated syndrome (CIS) and relapse-remitting MS (RR-MS), the most common presenting form of MS, in April.
Earlier open-label phase I/II clinical trials have shown the treatment to be safe, well tolerated and highly efficacious. The annual relapse rate for one group of patients was reduced by an impressive 92%. Furthermore, the treatment appears to lower the autoimmune myelin-reactive T-cells (MRTCs) in patients' blood and improve patients' clinical measures
The phase IIb trial, named TERMS, will assess the drug's impact in 100 patients over 52 weeks, with the primary outcome measure being reduction in the number of MS lesions. Successful completion of this trial could pave the way for a phase III pivotal trial to begin in mid-to-late 2007.
PharmaFrontiers is aiming to position Tovaxin as a first-line therapy for MS and, if the results seen to date can be replicated in TERMS and subsequent trials, this could be achieved, granting MS sufferers a much-needed ray of hope. Moreover, although several previous attempts at developing a successful MS vaccine have failed, if Tovaxin were to outshine its ill-fated predecessors and reach the market, it could also offer more convenient dosing than its rivals, giving it a promising competitive edge.
http://www.pharmaceutical-business-review.com/article_feature.asp?guid=7C84E38E-CC9B-4A83-B092-83D84E8128CC
posted by Bill at 12:31 AM
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