Monday, July 2, 2012
By: Gazette staff
Neuralstem, the Rockville company that’s 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
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
“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
Sirnaomics has won a Small Business Innovation Research grant from the
National Institutes of Health to help develop its nanoparticle technology for
healing skin wounds with minimal scar formation.
The grant is for $221,350, according to the NIH website; a Sirnaomics
spokesman said he could not confirm the amount.
It’s the privately held Gaithersburg company’s fifth such grant from NIH.
Besides the experimental wound treatment, Sirnaomics is testing the
technology for treating age-related macular degeneration and diabetic
retinopathy, respiratory influenza viral infection, and human papillomavirus
infection and cervical cancer.
The new grant “clearly demonstrates the scientific merits of Sirnaomics’
siRNA therapeutic program,” CEO Patrick Y. Lu said in a statement. “The
collaboration among scientists and clinicians from Sirnaomics, Johns Hopkins
University and Navy Medical Research Center provided a solid foundation for the
success of such a novel therapeutic approach.”
The market for reduced scarring treatments is about $4 billion per year, the
company said, citing marketing research. About 42 million surgery patients in
the U.S. could benefit annually from such treatments.
A Rockville biotech has won a $75,000 state grant to help it develop and
commercialize a monoclonal antibody treatment for the deadly Ebola virus.
Privately held BioFactura won the Maryland Technology Development Corp.
tech-transfer award under a federal program designed to meet the needs of the
Department of Homeland Security and the Army Medical Research and Materiel
The project also aims to demonstrate the capability of BioFactura’s Rapid
Human Antibody Generation system for developing biodefense countermeasures,
according to a company statement.
The grant follows a two-year, $1.8 million Pentagon grant in May for studies
to develop an improved scalable cell culture bioprocess to produce virus-like
replicon particle vaccines.
“The award of these two grants are key to advancing BioFactura’s innovative
drug development technologies in the context of biodefense medical
countermeasures,” CEO Darryl Sampey said in a statement. “Success in these
projects will yield critical products for the protection of our military
personnel and provide a wealth of data supporting BioFactura’s technology as it
relates to commercial drug and vaccine
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