Request for Proposals: Phase II Clinical Development of Novel, High-Potential Treatments for People with ALS

Request for Proposals: Phase II Clinical Development of Novel, High-Potential Treatments for People with ALS Letter of Intent: January 9, 2015 ALS ACT, The ALS Association, and the Translational Research Advancing Therapy  ALS (TREAT ALS) Northeast ALS Consortium (NEALS) clinical trials network, are pleased to announce a call for phase II clinical trial applications for novel, high-potential treatments for 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 $1,500,000 (direct costs only) in ALS ACT clinical research support is available. There is an urgent need for better ALS treatments and therapeutic agents. 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. 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). For this RFP, 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 ...
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