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news.The Immune Response Corporation has announced a new phase II study to evaluate NeuroVax, an investigational immune-based therapy for multiple sclerosis.
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NeuroVax is a T-cell receptor (TCR) peptide vaccine designed to specifically down-regulate the body’s destructive immune responses observed in multiple sclerosis (MS) patients to alleviate the impact of the disease.
The new open-label study will ultimately enroll 40 patients with relapsing remitting or secondary progressive multiple sclerosis, and will investigate the long-term safety, mechanism-of-action, and utility of a quarterly dosing regimen of NeuroVax.
Enrollment is expected to be completed by spring 2005 and results are expected in 2006.
Last year, the company presented data demonstrating that NeuroVax produced a peptide-specific immune response in 94% of the patients treated in a phase I/II clinical trial in MS. A separate open-label rollover study has now completed enrollment and is currently following those patients to evaluate the long-term safety of NeuroVax.
The new phase II study will build on the knowledge acquired in these studies and seek to further understand the mechanism-of-action of NeuroVax and explore possible dosing regimens.
“The NeuroVax data we’ve seen thus far lead us to believe that it may have a clinical benefit for MS patients and we are excited to begin this new phase II study to provide additional important information about the therapy’s mechanism-of-action and long-term safety,” said Dr John Bonfiglio, president and CEO of The Immune Response Corporation.