LINKPhase I/II clinical trials of Tovaxin(TM), a novel T cell therapeutic vaccine for Multiple Sclerosis, has been accepted for presentation at the 21st Congress of the European Committee/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis to be held September 28 - October 1, 2005, in Thessaloniki, Greece. The interim trial results have indicated that the treatment appears safe and well tolerated. In addition to the safety and tolerance indications, the study concluded that MRTCs in patients with MS can be depleted by Tovaxin(TM) treatment. Multiple Sclerosis Impact Scale (MSIS) and Kurtzke Expanded Disability Status Scale (EDSS) clinical measures are improved.
"Having the opportunity to present such encouraging data from Tovaxin(TM) clinical trials at such a prestigious international MS meeting is a great honor and very exciting for our researchers and all of the PharmaFrontiers staff. The acceptance of our abstract confirms our confidence as we move ahead with the development of Tovaxin(TM) for the treatment of patients who are in the early stages of MS," said David B. McWilliams, chief executive officer of PharmaFrontiers. "With our clinical development partner, INC Research, Raleigh, NC, we plan to initiate this pivotal Phase IIb/III clinical study of early relapsing MS patients by the first quarter of 2006 to advance our understanding of this novel T cell therapeutic vaccine for MS." Previous studies of T cell vaccination conducted by Jingwu Zhang, M.D., Ph.D., Director of Research, Baylor Multiple Sclerosis Center at The Methodist Hospital, and colleagues have shown that a monovalent (MBP selected MRTCs) formulation was safe and potentially beneficial in relapsing remitting and secondary progressive patients.