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ALS Consortium Opens a Request for Phase II Clinical Trial Applications

A consortium dedicated to finding a cure for amyotrophic lateral sclerosis (ALS), comprised of ALS ACT, The ALS Association, ALS Finding a Cure, and the Translational Research Advancing Therapy ALS (TREAT ALS™) Northeast ALS Consortium (NEALS), has just announced the official start of acceptance of proposals for Phase II clinical trials for potentially groundbreaking treatments for the disease. Review and acceptance of clinical trial applications will focus more on partnering compatible academic institutions, and industry authorities and companies under the NEALS consortium and with ALS-specialized scientists from all over the world. The ALS ACT will be awarding up to $1,500,000 (with as much as 10% of indirect costs) in research grants.

Estimates show that ALS affects about 1 in every 30,000 people, with diagnosed cases increasing by about 5,000 every year. Despite these numbers, the U.S. Food and Drug Administration has approved of only one treatment for ALS — Rilutek (riluzole). This Request for Proposals (RFP) aims to accelerate the long process of translating promising treatment research from laboratory to bedside. According to a press release, the RFP will only accept Phase II clinical trial proposals for potential treatments that involve “a pharmacodynamics marker that can measure whether pathway of interest has been affected and a plan to collect samples for biomarker studies.”

The executive committee of the ALS ACT will be reviewing submissions and stringently select grant recipients based on scientific rationale, merit, novelty, value of the project, availability of appropriate facilities, and the technical ability to conduct the clinical study.

Research funding will be awarded through support for infrastructure, per subject fee, sample collection, pharmacodynamic marker testing and other trial-related costs on an as-needed basis. Those submitting a study proposal may request for a combination of the following services available through NEALS: project management, grants and contracts management, data management, study monitoring, outcome measure development and training, biostatistical support, site selection, start up, regulatory document review, and ongoing site management and site trainings, which encompass good clinical practice, regulatory compliance and site management.

Those interested can learn more through the ALS Association’s website.

Posted by: Dr.Health

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