Here is a press release about the FDA phase IIb clinical trials and the protocol from the government clinical trials site.
Press release on FDA approval
October 31, 2005 04:00 AM US Eastern Timezone
PharmaFrontiers Tovaxin(TM) Phase IIb Multiple Sclerosis Clinical Trial Protocol Accepted by FDA
THE WOODLANDS, Texas--(BUSINESS WIRE)--Oct. 31, 2005--PharmaFrontiers Corp. (OTCBB: PFTR), a company involved in the development and commercialization of cell therapies, announced today that the protocol for its Phase IIb clinical trial of Tovaxin(TM), a novel T cell therapeutic vaccine for Multiple Sclerosis (MS), has been accepted by the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER).
"PharmaFrontiers is very excited to receive a 'green light' from the FDA for our Phase IIb clinical trial. Our earlier open-label Phase I/II clinical trials not only gave us the safety and tolerability data we sought, but we also observed a trend towards a reduction in annualized relapse rate (ARR) in excess of 90%, the lowering of the myelin-peptide reactive T cells (MRTCs) in patients blood and the improvement in patients' clinical measures," said David B. McWilliams, chief executive officer of PharmaFrontiers. "The Tovaxin clinical program continues to show promising results and we believe that the completion of this Phase IIb clinical trial will allow us to launch a Phase III pivotal trial."
Tovaxin is a trivalent formulation of attenuated 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. MRTCs are believed to play a critical role in the pathogenesis of MS. Because several myelin antigens are described as potential autoantigens for MS, depletion of MRTCs using a trivalent formulation may have enhanced therapeutic effects.
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.
"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," said Edward J. Fox, M.D., Ph. D., director of The MS Clinic of Central Texas (Austin) and the lead principal investigator for the upcoming clinical studies. "During this two-arm, 52-week, parallel-group study, patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate. Of the 150 patients participating in the trial, 100 will receive Tovaxin and 50 will receive the placebo."
All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin open-label. The open-label study is being planned under a different protocol that will be submitted to the FDA.
"A patient-specific therapeutic vaccination strategy, Tovaxin T cell vaccine is formulated using the MS patient's own myelin peptide-specific activated T cell lines, which are harvested and attenuated on the day of vaccine administration," said Jim C. Williams, Ph.D., PharmaFrontiers chief operating officer. "The shelf-life of the final product is approximately three days."
PharmaFrontiers will be conducting the Phase IIb with its clinical development partner, INC Research, Raleigh, NC.
http://www.clinicaltrials.gov/ct/action ... CEDAA4DBDE
Autologous T Cell Vaccine for Multiple Sclerosis
This study is not yet open for patient recruitment.
Verified by PharmaFrontiers Corp October 2005
Sponsored by: PharmaFrontiers Corp
Information provided by: PharmaFrontiers Corp
ClinicalTrials.gov Identifier: NCT00245622
A 1 year study to evaluate the efficacy, safety, and tolerability of Tovaxin T cell therapy in subjects with Clinically Isolated Syndrome (CIS) and Relapse-Remitting MS (RR-MS)
Condition Intervention Phase
Clinically Isolated Syndrome (CIS)
Relapse-Remitting Multiple Sclerosis (RR-MS)
Vaccine: Autologous T cell vaccine
MedlinePlus related topics: Multiple Sclerosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
Further Study Details:
Primary Outcomes: To evaluate the efficacy, safety, and tolerability of Tovaxin TCV in subjects with CIS or RR-MS
Secondary Outcomes: To evaluate biomarkers of efficacy of Tovaxin TCV and effects of Tovaxin TCV on epitope spreading
Expected Total Enrollment: 150
Study start: December 2005
Last follow-up: July 2007
A 2 arm, 52 week parallel-group of Tovaxin versus placebo in subjects with CIS or RR-MS. Subjects who provide written, informed consent will complete screening and procurement assessments and provide blood to be used for vaccine production. Eligible subjects will be enrolled to receive either Tovaxin or placebo and will complete baseline assessments. Randomization and enrolled subjects will receive study treatment by subcutaneous injections at weeks 0, 4, 8, 12, and 24. Subjects will be monitored by CBC, serum chemistries, urinalysis, EDSS, MSFC, MSQLI, MRI, and monitor myelin reactive T cells for safety, efficacy, and tolerability of Tovaxin.
Ages Eligible for Study: 18 Years - 45 Years, Genders Eligible for Study: Both
Age 18 to 45 years old
Diagnosis of MS within the past 3 years according to the McDonald criteria (2001)
Baseline EDSS score between 0 and 3.5 inclusively
Unable to produce T cell vaccine
Disease-modifying treatment for MS during the last 60 days
Diagnosis of progressive-relapsing, secondary progressive or primary progressive MS
Any prior treatment with total lymphoid irradiation, cladribine, T cell or T cell receptor vaccination
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00245622
Shannon M Inman 281-719-3405 MSBlood@pharmafrontierscorp.com
Study chairs or principal investigators
Edward J Fox, M.D., Ph.D., Principal Investigator, Central Texas Neurology Consultants
Jim C Williams, Ph.D., Study Director, PharmaFrontiers Corp
Study ID Numbers: TERMS Study; 2005-00
Last Updated: October 27, 2005
Record first received: October 20, 2005
ClinicalTrials.gov Identifier: NCT00245622
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-10-28