The quest to address long-term neurodegenerative problems associated with traumatic brain injury (NYSE:TBI) and concussions has received plenty of attention recently, in part because of high profile athletes raising awareness and also because of some breakthrough research by Boston University and the University of California at Los Angeles. With any advancement come arguments on both sides of the debate about the accuracy of statements without extensive clinical research, and the sobering reality is that there still are no reliable treatments for diseases like Alzheimer's disease and chronic traumatic encephalopathy (NASDAQ:CTE). All scientific posturing and argumentative rhetoric aside, the fact that companies are making strides in diagnostics and more resources are being devoted to these areas of tremendous unmet medical need are reason for optimism as there are new paths being carved in the evolution of new treatments.
In the public domain, the majority of companies steer clear of neurological conditions because of the elusive nature of answers and the often non-linear progression of these diseases that can make research extremely challenging. The other side of that coin is that successful research can reap tremendous returns from both corporate and humanitarian perspectives. Companies like Neuralstem, Inc. (NYSE MKT: CUR) and Aethlon Medical, Inc. (OTCBB: AEMD) are not shying away from the challenge and appear to be making substantive progress.
Neuralstem's lead drug candidate, a neural stem cell product called NSI-566, is a key driver for the company. It is in a phase 2 trial for Amyotrophic Lateral Sclerosis (ALS, or "Lou Gehrig's Disease), a disease where the progressive degeneration of motor neurons erodes communication between the brain, spinal cord and muscles, inevitably leading to death. Neuralstem is seeking a "Breakthrough Therapy" designation from the FDA for NSI-566 for ALS.
More precise to this article's topic, Neuralstem has NSI-189, a small molecule that in November finished a phase 1b trial in patients with major depressive disorder (NYSEARCA:MDD) and is currently in the midst of a comprehensive data review expected to run through the second quarter. The drug is being developed with the understanding that MDD is no longer believed to be strictly a condition of brain chemistry, but also a physiology, including reduced hippocampal volume. Early research has shown NSI-189 to increase volume of the hippocampus (a home for neural stem cells that is known to atrophy in depression) by up to 20 percent, lending to the hypothesis that stimulating the genesis of new neurons in the hippocampus could treat depression with a different approach than the commonly used selective serotonin reuptake inhibitors. The company is also researching the molecule's effect on conditions like TBI, Alzheimer's and Post-Traumatic Stress Disorder.
This physiological approach has captured the attention of the National Football League Alumni Association. Neuralstem and the NFLAA are working together on an initiative to develop NSI-189 as a new therapeutic to treat NFL alumni members suffering from traumatic brain injuries. Little development details have been disclosed, but as the data from the phase 1b trial for MDD is analyzed, it could lead to a significant step forward in TBI research at Neuralstem.
Aethlon Medical's Adaptive Dialysis-like Affinity Platform Technology, or ADAPT for short, is the foundation for their flagship product, called the Hemopurifier®, an extracorporeal filtration device that has been shown to selectively and rapidly remove a wide array of viral pathogens, including HIV, and tumor-secreted exosomes from the circulatory system. The company is furthest along with Hepatitis C research. Aethlon disclosed late in February that it has partnered with contract research organization DaVita Clinical Research, a subsidiary of DaVita HealthCare Partners, to provide clinical management services to support additional upcoming clinical trials of the Hemopurifier in end-stage renal disease patients infected with Hepatitis C virus.
Aethlon's medical device technology is complemented by the exosome expertise of its subsidiary Exosome Sciences Inc. From a broad perspective, research of exosomes, nano-size extracellular vesicles secreted by most every somatic cell and found in bodily fluids, is a rapidly emerging science that leading institutions, such as MD Anderson, have suggested could lead to revolutionary diagnostic tests. While MD Anderson is focused on oncology applications, recent discoveries indicate that exosomes could play a key role in diagnosing, and perhaps treating, degenerative brain conditions.
Aethlon and Exosome Sciences have recently made a potential breakthrough by successfully isolating brain-specific biomarkers in the blood that are associated with a variety of neurodegenerative disorders. Because exosomes can pass through the blood/brain barrier, the microscopic cargo haulers can carry vital information about neurodegenerative conditions happening in the brain. The companies' research identified exosomes carrying brain-specific markers, including tau, beta-amyloid and other proteins. Tau is of particular interest in CTE research as the accumulation of tau is a hallmark of CTE, a disease often identified in soldiers exposed to blast injury and attributed to suicides of high-profile athletes Junior Seau, Dave Duerson and Andre Waters that can only be officially diagnosed in an autopsy.
The potential to conduct a simple blood test to identify proteins that could implicate a condition like CTE or dementia at an early stage presents an opportunity for a new dynamic to identify and manage life-threatening and debilitating diseases. It also opens the door for innovative approaches as cornerstones to a new paradigm of research. This sort of research takes time, there is no denying that, but thanks to the efforts of organizations like Boston University and UCLA, funding support from the National Institute of Health, the National Football League and General Electric (NYSE: GE) and the pioneering efforts of companies like Neuralstem and Aethlon Medical, it's moving faster than ever before.
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