logo
Share SHARE
FONT-SIZE Plus   Neg

Neuralstem Obtains FDA Approval To Begin Phase II Stem Cell Trial In ALS

Neuralstem Inc. (CUR) announced Wednesday that it has received approval from the Food and Drug Administration or FDA to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis or ALS or Lou Gehrig's disease.

The company noted that the Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution.

According to the company, The trial is designed to treat up to 15 patients, in five different dosing cohorts. All of the patients will be ambulatory and reside within close geographic proximity to the research center where they will participate. The first 12 patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The final three patients will receive both cervical and lumbar injections.

"The aim of this Phase II trial is to obtain the maximum tolerated dose using the same route of administration as in Phase I, which was through direct injections into the gray matter of the spinal cord," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Women's specialty-clothing retailer J. Jill Inc. said it has launched an initial public offering of 11.67 million shares of its common stock. All shares are being sold by an existing stockholder and J. Jill will not receive any proceeds from the offering. Long queues at peak dining hours at Wendy's may be a history, as the company is planning to introduce automated self ordering kiosks at its more than 1000 retail locations by this year end. The automation will also help in cutting labor costs. Canadian music retail chain Sunrise Records said it plans to take over 70 retail spaces in Canada being vacated by HMV Canada, the industry's largest retailer. The new brick and mortar locations are in malls across Canada. However, Sunrise's expansion comes as people are increasingly shifting to streaming options for music and videos rather than buying tangible, touchable albums.
comments powered by Disqus
Follow RTT