| | NeuroVax- Quarterly Drug
Vaccine for multiple sclerosis, NeuroVax™ is an immune-based therapy designed to specifically down-regulate the body’s destructive immune responses observed in MS patients to alleviate the impact of the disease.
“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 John N. Bonfiglio, Ph.D., President and Chief Executive Officer of The Immune Response Corporation.
Last year, the Company presented data demonstrating that NeuroVax™ produced a peptide-specific immune response in 94 percent 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 announced today 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.
“This new Phase II study is designed to examine the durability of the immunological responses we’ve seen in patients receiving NeuroVax™,” said Georgia Theofan, Ph.D., Vice President of Clinical Development at The Immune Response Corporation. “We may be able to successfully maintain these responses with a quarterly dosing regimen which would be an important benefit to patients.”
The new open-label study will ultimately enroll 40 patients with relapsing remitting or secondary progressive multiple sclerosis, of which approximately 30 will be rollover patients from a previous study. Patients in this new study will receive three monthly NeuroVax™ injections followed by three quarterly injections. Enrollment is expected to be completed by spring 2005 and results are expected in 2006.
The Company’s strategy for the development of NeuroVax™ includes not only the expansion and completion of the current and new Phase II trials, but also the initiation in summer 2005 of a large placebo controlled trial designed with magnetic resonance imaging (MRI) and clinical endpoints to examine the clinical benefit of NeuroVax™. The Company also intends to search for a corporate partner to help take this program to commercialization