Tovaxin update
Posted: Mon Sep 18, 2006 5:22 am
Opexa Commences Phase IIb Multiple Sclerosis Study
Reports Positive Phase I/II Data.
Opexa Therapeutics, Inc., a company involved in the development and commercialisation of cell therapies, today announced a number of positive steps in the Company's development including: Its Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun.
More than 90 attendees from 35 clinical sites attended the investigators' meeting held recently in The Woodlands. These sites have begun screening patients for the 150-patient trial. Opexa expects that the first patients will be enrolled early in the fourth quarter of this year. Positive data from the Phase I/II trial with Tovaxin in multiple sclerosis indicate that after 12 months, patients exhibited a relapse rate reduction of more than 90%.
Commenting on the Phase IIb study, Edward J. Fox, M.D., Ph. D., Clinical Assistant Professor, University of Texas Medical Branch, and director of the MS Clinic of Central Texas (Austin), the lead principal investigator for the Phase IIb study said, "The investigators at the kick-off meeting held in late August expressed a great deal of enthusiasm for this trial and were ready to begin screening patients. We are optimistic that this trial will advance our understanding of Tovaxin as a possible safe and effective treatment for Multiple Sclerosis."
As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby 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 annualised relapse rate.
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.
David McWilliams, president and chief executive officer of Opexa said, "We are pleased to begin this trial and based on recent data from our Phase I/II studies, we believe that those early results support the rationale for moving forward. We now have 12-month data from our two earlier studies, which indicate that the patients treated had a greater than 90% annualised relapse rate reduction, as compared with their prior history."
About Opexa Therapeutics
Opexa Therapeutics develops and commercialises cell therapies to treat several major disease areas such as MS, rheumatoid arthritis, pancreatic and cardiac conditions. Opexa has exclusive license from Baylor College of Medicine for individualised cell therapies and has initiated a Phase IIb clinical trial to evaluate effectiveness in treating MS.
Source: Opexa Therapeutics, Inc.
Reports Positive Phase I/II Data.
Opexa Therapeutics, Inc., a company involved in the development and commercialisation of cell therapies, today announced a number of positive steps in the Company's development including: Its Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun.
More than 90 attendees from 35 clinical sites attended the investigators' meeting held recently in The Woodlands. These sites have begun screening patients for the 150-patient trial. Opexa expects that the first patients will be enrolled early in the fourth quarter of this year. Positive data from the Phase I/II trial with Tovaxin in multiple sclerosis indicate that after 12 months, patients exhibited a relapse rate reduction of more than 90%.
Commenting on the Phase IIb study, Edward J. Fox, M.D., Ph. D., Clinical Assistant Professor, University of Texas Medical Branch, and director of the MS Clinic of Central Texas (Austin), the lead principal investigator for the Phase IIb study said, "The investigators at the kick-off meeting held in late August expressed a great deal of enthusiasm for this trial and were ready to begin screening patients. We are optimistic that this trial will advance our understanding of Tovaxin as a possible safe and effective treatment for Multiple Sclerosis."
As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomised, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby 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 annualised relapse rate.
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.
David McWilliams, president and chief executive officer of Opexa said, "We are pleased to begin this trial and based on recent data from our Phase I/II studies, we believe that those early results support the rationale for moving forward. We now have 12-month data from our two earlier studies, which indicate that the patients treated had a greater than 90% annualised relapse rate reduction, as compared with their prior history."
About Opexa Therapeutics
Opexa Therapeutics develops and commercialises cell therapies to treat several major disease areas such as MS, rheumatoid arthritis, pancreatic and cardiac conditions. Opexa has exclusive license from Baylor College of Medicine for individualised cell therapies and has initiated a Phase IIb clinical trial to evaluate effectiveness in treating MS.
Source: Opexa Therapeutics, Inc.
