ALS ACT, a novel academic-foundation-industry partnership; the ALS Association, a Wash. D.C.-based national nonprofit organization; and the translational Northeast ALS Consortium (NEALS) clinical trials network 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 $1.5 million (direct costs only) in ALS ACT clinical research support is available.
In the U.S., ALS, also known as Lou Gehrig's Disease, affects one in approximately 30,000 people, with 5,000 new diagnoses each year. There currently is one FDA-approved treatment for ALS, Riluzole (Rilutek). The goal of this Request for Proposals (RFP) 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 RFP, potential phase II clinical trials should include therapeutic interventions that have 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.