Neuralstem, the Rockville company thats developing a stem cell treatment for patients with amyotrophic lateral sclerosis, has begun testing the safety of its treatment for major depressive disorder.
The compound, NSI-189, stimulates new neuron growth in the brain's hippocampus region, which scientists think is involved in depression and other conditions, including Alzheimer's disease, anxiety and post-traumatic stress disorder, according to a company statement. The phase 1b study involves 24 depressed patients and is expected to run six months.
"We believe it could help patients who suffer from depression via a new mechanism that does not seek to modulate brain chemistry, but rather stimulates new neuron growth in the hippocampus and increases hippocampal volume, thereby potentially addressing the problem at the source," Karl Johe, Neuralstem's chief scientific officer, said in the statement.
The company has researched hippocampal stem cell lines since 2000 and in 2009 won U.S. patents for four chemical entities that generate new neurons. In studies, NSI-189 stimulated such growth in mice.
In other Maryland bioscience industry news:
Supernus Pharmaceuticals has received tentative marketing approval from the Food and Drug Administration for its once-daily, extended release version of an epilepsy treatment.
The FDA said it has completed its review of Trokendi XR and no more clinical trials are required. Final approval hinges on resolving a marketing exclusivity issue that involves a specific pediatric population, according to the FDA's letter to Supernus.
Trokendi XR is an extended-release version of topimarate, which is marketed as Topamax by Janssen Pharmaceuticals of Titusville, N.J., to treat seizures and migraine headaches.
"We will continue to work closely with the FDA to further understand the outstanding issue and move forward towards final approval," CEO Jack Khattar said in the statement.
Supernus, which went public this year, also said the FDA denied a petition filed in 2011 by Upsher Smith Laboratories related to its Trokendi XR application.
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Gazette.Net: Rockville biotech tests stem cells for depression