ALS Accelerated Therapeutics (ALS ACT), the ALS Association, and the Translational Research Advancing Therapy ALS (TREAT ALS) Northeast ALS Consortium (NEALS) clinical trials have announced a call for phase II clinical trial applications for novel, high-potential treatments in amyotrophic lateral sclerosis (ALS).
The call for clinical study proposals is directed toward academic-industry partnerships, including pharmaceutical, biotherapeutic/biotechnology companies, academic members of the NEALS Consortium, and ALS scientists throughout the world. Up to US$1,500,000 in direct costs in ALS ACT clinical research support is available.
In the United States, ALS affects one in approximately 30,000 people, with 5,000 new diagnoses each year. There is currently one FDA-approved treatment for ALS – Riluzole (Rilutek). The goal of this request for proposals is to expedite the process of bringing new treatments forward for testing in people with ALS and to measure if that therapeutic agent is reaching its target.
For this request for proposals, potential phase II clinical trials should include therapeutic interventions that have the following attributes: A pharmacodynamics marker that can measure whether pathway of interest has been affected and a plan to collect samples for biomarker studies.
The ALS ACT steering committee will review the applications, which will be judged on scientific rationale, merit, novelty, and the value of the project and the availability of appropriate facilities and the technical ability to carry out the clinical study.
Funds will be awarded in the form of infrastructure support provided by NEALS and funds for per subject fee, sample collection, pharmacodynamic marker testing and other trial-related costs as needed. Applicants may apply for a combination of any of the following clinical research support 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.