News Coverage
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Excerpts from Tom Henderson’s Interview with Dr. Eva Feldman
Neuralstem’s NSI-566/ALS Principal Investigator Eva L. Feldman, MD, PhD, shares that she is continuing tests of the 15 patients in the Phase II trial to determine how the injection of the neural stem cells slows down the progression of the disease. She states that she hopes to begin the next phase of the trials, which will involve 32 ALS patients, in the first quarter of 2015. Dr. Feldman went on to say that her results from just-concluded animal research injecting 50,000 stem cells into a line of mice that have inherited genes for Alzheimer’s disease has exceeded her expectations. “I’m so geeked about this…. We’ve never seen data like this. They’ve (the mice) have essentially gone back to normal,” Dr. Feldman said. She is awaiting word from the FDA on which large mammal to use in the next set of Alzheimer’s tests. “If everything goes well, in a year from now we can be talking about clinical trials on humans,” she told Crain’s Tom Henderson.
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Researchers Fret as Social Media Lift Veil on Drug Trials
Neuralstem’s President and CEO, Richard Garr, is interviewed in this front-page feature story that examines patient-directed social media’s impact on blinded clinical trials. While Neuralstem’s NSI-566 cell therapy trials have not been blinded, ALS patients have independently chosen to blog online or speak publicly about their treatments during the trials which represent the first FDA-approved neural stem cell clinical trials for the treatment of ALS, with Phase I begun in 2010 and the Phase II surgeries of the final cohort nearly concluded.
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Neurogenic Drug Improves Depression in Small Trial
Science Editor Cynthia Fox issued a report on first-in-class neurogenic NSI-189/major depressive disorder (MDD) Phase I data, presented by Mass Gen/Harvard’s Dr. Marlene Freeman, at ASCP’s annual meeting. She reports that “depressed patients taking two different doses of the drug have now experienced a ‘clinically meaningful’ relief of depressive and cognitive symptoms across all measures in comparison to placebo. This relief continued throughout the follow-up period,” which was for two months following the 28-day dosing. Neuralstem’s President and CEO, Richard Garr, is quoted as saying, “this is a very solid sign pointing to confirming our thesis that what we see in animals—structurally rebuilding the hippocampus—is also happening in humans.”
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ALS Breakthrough Involves Rhode Island Patient
NSI-566/ALS Phase II patient on Rhode Island ABC Channel 6 Report.
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Neuralstem could seek partner for Phase II depression small molecule; to develop stem cell therapy solo – CEO
Neuralstem’s President and CEO discusses neurogenic small molecule lead compound, NSI-189, commercialization strategy with global life sciences business intelligence group, BioPharm Insight. Garr notes a partnership commitment would require the full potential of NSI-189 as a neurogenic agent in all potential indications on a global basis. The company plans to file an IND in late summer or early 3Q14 to commence the NSI-189 Phase II clinical trial in major depressive disorder before year-end, with Dr. Maurizio Fava, professor of Psychiatry, Harvard Medical School, cited as likely to be the principal investigator.
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- A Closer Look At Neuralstem’s ALS Treatment