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Clinical Trial Proposals Sought for ALS Treatments

3-D brain wiring illustration

3-D brain wiring illustration (NIH)

22 October 2014. A group of U.S. organizations promoting research on therapies for amyotrophic lateral sclerosis or ALS are seeking proposals from academic-industry research teams for intermediate stage clinical trials to test treatment candidates for the disease. The organizations — ALS Association, ALS Accelerated Therapeutics or ALS ACT, and Northeast ALS Consortium — plan to award up to $1.5 million in research support, with letters of intent due by 9 January 2015.

Amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, is a progressive disorder that attacks nerve cells or neurons controlling voluntary muscle movements. In ALS, motor neurons in the brain stop sending signals to motor neurons in the spinal cord, and thus stop sending signals to muscles. Muscles begin to weaken and atrophy, eventually losing control over voluntary muscle movement. The result is disability and paralysis, including respiratory functions, leading to death. ALS affects 1 in about 30,000 people in the U.S., with 5,000 new cases each year.

At present there is no cure for ALS and only one approved drug — Riluzole, marketed as Rilutek by Sanofi — that slows the progress of the disease. The organizations say the research funded in this initiative can fill an urgent need for more treatments, particularly those beyond preclinical and early safety studies on humans.

Proposals should outline intermediate-stage studies of interventions that include markers to measure the therapy’s affect on the body, as well as a plan to collect samples for studies involving biomarkers. Intermediate-stage trials, sometimes called phase 2 trials, are studies involving larger numbers of patients than the small samples used in earlier safety studies, and test the effectiveness of the drug, as well as watch for safety or side-effects issues.

The organizations encourage teams comprised of academic and industry researchers, including those from pharmaceutical and biotechnology companies, to submit proposals. Letters of intent are due by 9 January 2015, with invitations to send in full proposals issued on 23 January. Full proposals are due by 2 March 2015, with evaluations conducted by a review panel from ALS ACT.

The winning proposal will be announced in May 2015. The successful bidder, say the organizations, will retain control of the study as well as intellectual property of the therapy being tested.

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