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| ![]() | ![]() PharmaFrontiers Reports Third Quarter 2005 Financial Results; Provides Update on Research & Development ActivitiesPress Release November 15, 2005 THE WOODLANDS, Texas--(BUSINESS WIRE)--Nov 15, 2005 - PharmaFrontiers Corp (OTCBB: PFTR), a company involved in the development of novel cell therapies, including one for Multiple Sclerosis which is about to enter Phase IIb clinical trials, announced today its financial results for the three and nine month periods ended September 30, 2005, as well as providing an update on its research programs and future plans. Highlights during the third quarter of 2005 and recent weeks included: -- Positive interim research findings of PharmaFrontiers' Phase I/II clinical trials of Tovaxin(TM) presented at the 21st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the 10th Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) congress held in Thessaloniki, Greece; -- PharmaFrontiers Tovaxin Phase IIb Multiple Sclerosis Clinical Trial Protocol accepted by the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER); -- Election of Brooks Boveroux as chairman of the board and the reconstitution of the Company's audit committee with Mr. Boveroux as its chairman; -- Retention of MDB Capital Group to serve as the Company's financial advisor. Research and Development In October, the Company presented positive interim research findings of its Phase I/II clinical trials of Tovaxin at the 21st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the 10th Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) congress held in Thessaloniki, Greece. The trial results indicated that the treatment appeared safe and well tolerated with no dose-limiting toxicities, and that Tovaxin depletes the myelin-peptide reactive T cells that may contribute to the Multiple Sclerosis (MS) disease processes. More recently, PharmaFrontiers announced that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) had approved the protocol for its Phase IIb clinical trial of Tovaxin. PharmaFrontiers will be conducting the Phase IIb with its clinical development partner, INC Research, Raleigh, NC. The Company expects to commence this pivotal Phase IIb study by the end of 2005 or early 2006. This multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study is designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell therapy with clinically isolated syndrome (CIS) and early relapsing-remitting MS (RR-MS) patients. Additionally, the study of these patients will evaluate biomarkers of Tovaxin's efficacy and to evaluate the effect of Tovaxin on immune deviation and epitope spreading. David McWilliams, chief executive officer of PharmaFrontiers Corp, commented, "The Tovaxin clinical program continues to show promising results and this `green light' from the FDA is a significant milestone for us. We believe that the protocol design will allow us to study the clinical effects of Tovaxin in a group of patients requiring a safe and effective therapy. More importantly, we also believe that the successful completion of this Phase IIb clinical trial will allow us to launch a Phase III pivotal trial, bringing us towards our ultimate goal in allowing the power of our technology to treat those who are afflicted with Multiple Sclerosis."
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