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Call for Proposals for Phase II Clinical Trials from MGH Neurological Clinical Research Institute and The ALS Association

April 30, 2013

The ALS Association and the Massachusetts General Hospital Neurological Clinical Research Institute (NCRI) announce a call for Phase II clinical trial applications for novel, high potential treatments for ALS. There is an urgent need for improved ALS therapies as there is currently only one FDA-approved treatment for the disease, riluzole (Rilutek®). This Request for Proposals (RFP) aims to expedite the development of new therapies to test in people with ALS.

NCRI and The ALS Association encourage academic-industry partnerships, including those involving pharmaceutical, biotherapeutic, biotechnology companies, academic members of the Northeast ALS Consortium (NEALS), and ALS scientists throughout the world, to submit clinical study proposals. Clinical research support totaling $800,000 USD (direct costs only) is available.

Potential Phase II clinical trials should include 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. A joint NCRI and ALS Association steering committee will review applications, which will be judged on scientific rationale and merit, novelty and the project’s value as well as the availability of appropriate facilities and the technical ability to complete the clinical study.

Deadlines for the letter of intent and other forms are listed in this document. Send letters of intent to by May 20, 2013.

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