Single-Site Pilot Studies
Some very novel agents are currently being developed by individual Center Without Walls funded centers. Single-site studies serve the valuable function of deriving preliminary data that, if encouraging, will come to fruition as larger collaborative trials:
The Oregon Health Center has completed the analysis of a single-site study of vaccination with a portion of the T cell receptor, Neurovax, that is well tolerated in patients with MS. This vaccine triggers a vigorous immune response to the vaccine and boosts regulatory cells in most patients. Further, two patients who reacted against brain myelin lost their reactivity on treatment. This study has provided data needed to successfully design the follow-up trial of this vaccine in MS.
The group at OHSU has completed a study of three different formulations of oral alpha lipoic acid in which 24 patients participated. One of the formulation gave the highest plasma levels of lipoic acid. This will lead to a study combining lipoic acid and interferon in patients with secondary progressive MS.
Neuroprotection with riluzole in early MS
UCSF has initiated one of the first study with a neuroprotective drug, riluzole, in patients with early MS. Riluzole is an approved drug already shown to slow down Lou Gehrig’s disease. Patients receive two year therapy with riluzole or placebo in addition to interferon beta-1a as a standard of care. Five patients have been enrolled in the study since January 2007. A total of 40 patients will participate to this study at UCSF. Sanofi-Aventis is providing free riluzole and placebo, and Biogen Idec is providing free interferon beta-1a. It is likely that OHSU will collaborate to this project if enrollment is slow at UCSF.
Salbutamol and Copaxone
Following the finding that Salbutamol (used in asthma) decreases the release of IL-12, a pro-inflammatory product that is deleterious in MS, the group at Harvard has continued with their study of Copaxone plus Salbutamol to determine if the association enhances the anti-inflammatory effect of Salbutamol. Being able to decrease the release of the pro-inflammatory product could prevent exacerbations of MS. Four patients are still in this study and will complete participation by December 2007.
Omega-3 fatty acid in the treatment of depression and as an immunomodulator
OHSU is continuing with the study of omega-3 fatty acid in the treatment of depression in patients with MS and is also evaluating how this compound modulates the immune system in a way that could benefit to MS.
American ginseng for MS fatigue
OHSU is continuing the study with American ginseng for treatment of MS fatigue. Twenty seven patients are currently participating to this trial.
High dose cyclophosphamide study
Nine patients have been treated at Johns Hopkins with immunoablative doses of IV cyclophosphamide in patients with RRMS refractive to other therapies. The study will enroll a total of 10 patients.
Alpha Lipoic Acid
OHSU will test the pharmacokinetics of two other oral alpha lipoic acid formulations in the coming year so they can choose the best compound for the trial of oral lipoic acid as an adjuvant therapy to interferon beta for patients with secondary progressive MS.
Ginkgo Biloba for Cognitive Impairment in MS
OHSU is about to start a study in 100 patients that will test Ginkgo compared to placebo for six months as a treatment of cognitive problems related to MS.
Harvard is planning a phase II trial with CTL4-Ig based on the data reported last year for the phase I trial.
Harvard is planning a phase I trial with oral anti-CD3 monoclonal antibody that suppresses the animal model for MS. This study will evaluate several doses of the medication and will determine if the therapy induces regulatory cells in the blood.