ALS ACT, The ALS Association, ALS Finding a Cure, and the Northeast ALS Consortium Issue Request for Proposals for Phase II Clinical Development of Novel, High-Potential Treatments for ALS

Oct 23, 2015, 08:00 ET from The ALS Association

WASHINGTON, Oct. 23, 2015 /PRNewswire-USNewswire/ -- ALS ACT, The ALS Association, ALS Finding a Cure 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 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 $1,500,000 (including a maximum of 10 % indirect costs) in ALS ACT clinical research support is available.

ALS, also known as Lou Gehrig's Disease, is a progressive neurodegenerative disease that affects neurons (nerve cells) in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. There is no cure and no life-prolonging treatments for the disease. 

There is an urgent need for better ALS treatments and therapeutic agents. 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 (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 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 (unless the TREAT ALS™ NEALS clinical trials network is utilized, in which case infrastructure costs will be covered by the network and does not need to be included in the $1.5 million budget), 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.

Deadlines, contact information and selection criteria are available here.

About ALS ACT
ALS ACT is a novel academic-foundation-industry partnership to accelerate treatments for people living with ALS. In partnership with The ALS Association and the recently formed The ALS Finding a Cure Team, composed of researchers from General Electric (GE) Healthcare and four academic Northeast ALS Consortium (NEALS) sites, ALS ACT will enact a multi-pronged approach to expediting clinical trials in ALS.

About Northeast ALS Consortium
The Northeast ALS Consortium (NEALS) is an international, independent, non-profit group of researchers who collaboratively conduct clinical research in Amyotrophic Lateral Sclerosis (ALS) and other motor neuron diseases.  NEALS mission is to translate scientific advances into new treatments for people with ALS and motor neuron disease as rapidly as possible.  The ALS Association provides infrastructure support for the TREAT ALS NEALS Clinical trial network. NEALS has over 100 member sites in the United States, Canada, Ireland, and Israel.

About The ALS Association
The ALS Association is the only national non-profit organization fighting Lou Gehrig's Disease on every front.  By leading the way in global research, providing assistance for people with ALS through a nationwide network of chapters, coordinating multidisciplinary care through certified clinical care centers, and fostering government partnerships, The Association builds hope and enhances quality of life while aggressively searching for new treatments and a cure.  For more information about The ALS Association, visit our website at www.alsa.org.

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SOURCE The ALS Association



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