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

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


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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