The ALS Association

ALS Ice Bucket Challenge Progress

Neuraltus Pharmaceutical NP001 Trial Accepting Qualified Participants

July 19, 2011

NP001, a novel, proprietary approach that regulates macrophage activation, targets diseases including Amyotrophic Lateral Sclerosis (ALS), Parkinson’s disease, Alzheimer’s disease and multiple sclerosis. NP001 is designed to transform select immune cells (macrophages) from a neurotoxic state to a neuroprotective state, normalizing the cellular environment of critical nerve cells.

Neuraltus’ focus on macrophages is based on the recent understanding of the fundamental role of inflammation and macrophages in neurological diseases. Runaway inflammation has been associated with many of the symptoms seen in severe neurological diseases and is believed to play a major role in the progression of these diseases. Treating inflammation of the central nervous system (neuroinflammation) provides a robust platform for addressing upstream disease mechanisms associated with the most severe neurodegenerative diseases.

“This is an incredibly exciting time in ALS research with many novel and particularly exciting therapies being tested,” said ALS Association Chief Scientist Lucie Bruijn. “We encourage qualified candidates to enroll in this and other trials to hasten the process of gathering of data, which can lead to the discovery of effective therapies. However, until trials are completed, there is no way to know whether the agent under study is working.”

“The Neuraltus trial provides promise and is based on a rational scientific hypothesis targeting neuroinflammation,” said Richard Bedlack M.D. Duke University, Dept of Neurology. “This is one of many hypotheses that are being investigated as a key contributor to the disease.

We are very positive about the scientific underpinning of this trial—attacking neuroinflammation at the cellular level,” said Principal Investigator Robert G. Miller, M.D. of Forbes Norris ALS Treatment and Research, California Pacific Medical Center. “We have been very happy with the safety record to date of NP001.”

The Neuraltus Pharmaceuticals NP001 clinical trial is a Phase II double-blind, randomized, placebo-controlled multi-center study. The purposes of the trial include efficacy, safety and dosage. Patients receive a total of 20 intravenous injections of anywhere from 3 to 5 injections each month. There are to be two different dosage groups and one placebo group and will have a duration of six months plus three additional months of monitoring. The trial is currently recruiting at several locations throughout the United States. To view the trial criteria visit http://clinicaltrials.gov/ct2/show/NCT01281631.

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