NeuroVax T cell receptor peptide based vaccine achieves primary endpoint in phase I/II multiple sclerosis trial

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NeuroVax T cell receptor peptide based vaccine achieves primary endpoint

in phase I/II multiple sclerosis trial

Feb 27, 2002 (Datamonitor) - The Immune Response has reported that an

interim analysis by the company of its phase I/II clinical study of

NeuroVax in multiple sclerosis, confirmed that the primary endpoint had

been met.

The interim analysis of the primary endpoint was performed according to

an a priori definition of responder. A total of 20 subjects were

included in the interim analysis that compared responses to peptides in

Incomplete Freund's Adjuvant (IFA), peptides in saline and IFA alone.

The group of subjects receiving intramuscular injections of peptides in

IFA (NeuroVax) demonstrated a statistically significant response as

compared to the group receiving intradermal injections of peptides in

saline or the group receiving IFA alone. Based on these statistically

significant results and after discussion with the principal

investigator, Dr Dennis Bourdette, Oregon Health Sciences University,

the company plans to amend the trial protocol to allow all participants

currently enrolled to receive NeuroVax. The company plans to discuss

these results with the FDA regarding the design of the next trial. " This

is an important milestone in the development of T cell receptor peptide

therapy. We finally have early clinical study indications of a vaccine

candidate that may boost natural regulatory T cells in most, if not all,

of the patients. It is gratifying to observe just how vigorous the

responses were in all of the patients injected with NeuroVax. These

results will allow us to potentially move forward much more quickly to

design and conduct an efficacy trial, " said Dr Arthur Vandenbark,

Portland VA Medical Center, co-inventor of the technology, in a release.

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