NeuroVax provides positive results for MS

The Immune Response Corporation, a US-based biopharmaceutical company developing immune-based therapies (IBT) for HIV and select other diseases, has shown that its investigational T-cell receptor (TCR) peptide vaccine, NeuroVax, produced a peptide-specific immune response in 94% of the patients treated in a Phase I/II clinical trial in multiple sclerosis.

The three-armed, randomised trial was discontinued early when an interim analysis revealed the high rate of response. Earlier clinical research on immunotherapy for multiple sclerosis suggested that only about half of patients had an immune response to treatment with a single TCR peptide but that this reaction probably had clinical benefit. NeuroVax is composed of a combination of TCR peptides from three families (BV5S2, BV6S5, and BV13S1) with an adjuvant to improve immune response rates.

'The surprisingly high immunogenic response to NeuroVax, both in the percentage of patients responding and in the strength of their responses, validates this new approach to enhancing TCR peptide immunization and suggests that we may finally be able to more specifically regulate the pathogenic T-cells thus addressing the underlying causes of the disease,' said Dr Dennis Bourdette, chairman of the department of Neurology at Oregon Health & Science University in Portland, Oregon, and lead investigator for this study. 'Patients with multiple sclerosis currently have few treatment options. Our research is continuing to determine if the active immune response to NeuroVax correlates with a clinically relevant impact on disease progression.'

'With 94% of patients showing a disease-specific immune response in this study, we will continue to pursue development of NeuroVax in multiple sclerosis as both a monotherapy and in combination with currently approved treatments, said Dr John Bonfiglio, chief executive officer of The Immune Response Corporation. 'NeuroVax is another example of how immune-based therapies pioneered by The Immune Response Corporation's co-founder, Dr Jonas Salk, may provide a promising new mechanism for fighting difficult diseases. Together with our product candidates for HIV, Remune and IR103, I believe our pipeline is making the progress necessary to eventually commercialise products to meet patient needs in two underserved areas.'

Multiple sclerosis

Multiple sclerosis is an autoimmune disease in which the immune system, the body's principal defence against foreign substances such as bacteria, mistakenly attacks normal tissues of the central nervous system. It afflicts approximately 400,000 people in the United States and more than 2.5m worldwide. Specifically, the disease results in the loss of a fatty tissue called myelin that surrounds and protects nerve fibers, creating scarring (sclerosis) that interferes with the normal transmission of nerve impulses. This, in turn, leads to a variety of highly individual and unpredictable neurological symptoms, ranging from movement and balance problems to vision impairment. It is believed that a subset of the specific class of white blood cells, CD4+ T-cells, that normally plays an important role in the immune system, somehow becomes autoreactive and is principally responsible for the progression of the disease. TCR peptides have been shown to stimulate regulatory T-cells capable of suppressing the autoreactive CD4+ T-cells in a certain proportion of patients. NeuroVax, which combines three TCR peptides with an adjuvant, was designed to increase the likelihood of this immune reaction.