NP-001
ALS-ETF spent much of 2015 preparing to launch a multi-site Expanded Access trial for the investigational drug NP-001, a proprietary immunomodulation drug owned by Neuraltus Pharmaceuticals. As a potential ALS treatment, the product is generally well regarded by the key opinion leaders in the disease community. By 2012, clinical studies of this drug had generated enough data to make it eligible for Expanded Access in the U.S.
Our charitable partners have committed the financial support necessary for ALS-ETF to sponsor and manage an NP-001 Expanded Access program for at least two years, allowing our collaborative network to cover all tasks, including regulatory filings, site selection and monitoring, pharmacovigilance, data collection, as well as funding for product delivery and treatment. It will begin with up to 100 patients across the country, and may grow to much larger numbers depending on additional resources. However, we cannot launch without the permission of the drug company, and we hope Neuraltus will give the green light soon, in a partnership that allows doctors and patients to receive their potentially effective product through our platform.
|