An upcoming webinar will focus on the novel approach to clinical trial design in the Modifying Immune Response and Outcomes in ALS (MIROCALS) trial, which aims to break the current impasse in therapy development for amyotrophic lateral sclerosis (ALS).
During the webinar, P. Nigel Leigh, a motor neuron disease expert and chief trial investigator of MIROCALS, will discuss the Phase 2 trial, which is currently recruiting participants to test the efficacy and safety of low-dose interleukin-2 in ALS patients.
The webinar goes live on Wednesday, Feb. 13, 2019, at 11am EST (4pm GMT). Registration for the webinar is through the webpage, A Novel Approach to ALS Trial Development.
Despite increased understanding of the mechanism underlying ALS, the promises of new therapies remain elusive.
In December 1995, Rilutek (riluzole), the first drug approved by the U.S. Food and Drug Administration (FDA) to treat ALS, showed that it is possible to modify the disease’s progression.
However, subsequent trials of potential ALS treatments have failed, indicating that the strategies behind the development of these therapies — including trial design, patient selection, and outcome measures — need to be re-evaluated to ensure the current impasse is broken.
During the webinar, Leigh will discuss MIROCALS’ novel trial design, strategies for participant recruitment and stratification, and the use of biomarkers and RNA analysis.
The MIROCALS trial (NCT03039673) will be conducted in multiple centers in the U.K. and France. Estimated enrollment is 216 patients.
Patients will be randomized to receive low-dose interleukin-2 or a placebo (control group), delivered into the blood, as an add-on therapy to Rilutek, the standard ALS therapy. The doses will be given during five days, every four weeks, for up to 18 months.
Interleukin-2, which is used for treatment of some rare types of cancer, is a signalling molecule that regulates specific components of the immune system. It increases the production of special immune cells — regulatory T-Cells — that are thought to play an important role in controlling inflammation and protecting motor neurons — T-cells that may ultimately be able to influence the speed of ALS progression.