MSP-771

Neurocrine Biosciences/ Novartis

II

MSP-771 is an altered peptide ligand based on the immunodominant epitope of human MBP. Immune responses directed against this epitope may be involved in the pathogenesis of MS. In vitro, MSP-771 fails to induce T-cell proliferation and selectively reduces the production of inflammatory cytokines by pathogenic T cells. In the EAE model, MSP-771 markedly reduces the severity of disease and induces a specific T-cell response that down-regulates the inflammatory process. The molecule was well tolerated in a phase I study, with the most common side effect being local, transient injection site reactions. The primary endpoint in current clinical trials is the progression or regression of lesions in the brains of these patients as measured by MRI. As a secondary endpoint, clinical investigators will look for the generation of a protective immune response as shown in the Phase I trials.

PhRMA Database

Interleukin-10 (IL-10)

Schering-Plough

I/II

IL-10 has a number of inhibitory functions such as inhibiting interferon g production, antigen presentation, and the production by macrophages of the cytokines IL-1, IL-6 and TNFa.

UCSF MS Center

DEFINITIONS

Preclinical testing. A pharmaceutical company conducts laboratory and animal studies to show biological activity of the compound against the targeted disease, and the compound is evaluated for safety.

Phase I. Tests that involve about 20 to 80 normal, healthy volunteers. The tests study a drug's safety profile, including the safe dosage range. The studies also determine how a drug is absorbed, distributed, metabolized, and excreted as well as the duration of its action.

Phase II. Controlled trials of approximately 100 to 300 volunteer patients (people with the disease) assess a drug's effectiveness.

Phase III. Tests involving 1,000 to 3,000 patients in clinics and hospitals. Physicians monitor patients closely to confirm efficacy and identify adverse events.