The long term effects of contact sports are something that has long been neglected in the biotech space. Through both lack of quantitative evidence, and lack of financial incentive, very little is known about how and why athletes experience the complications they do later in life. Because of this, diagnosis and treatment is often late in coming and lacking in efficacy when it does. Chronic Traumatic Encephalopathy (CTE) is perhaps the prime example of this. CTE is a degenerative neurological condition that affects athletes across a range of contact sports, and a number of companies have turned their attention to the condition.
Before we look at the companies involved, a more in depth look at CTE is in order. The most basic thing to know is that repeated head trauma seems to be the cause. There is a wide range of encephalopathy related disorders caused by pathogens including bovine spongiform encephalopathy AKA mad cow disease. This specific instance is the CT version, with CT referring to the repeated head trauma. A more colloquial name for the condition is punch drunk, derived from its prevalence among boxers.
The biotech space doesn’t really know much about CTE, it being only newly discovered. It only knows that it is prevalent among athletes prone to repeated head trauma – and this has led to the assumption that the trauma is at the root of the condition. At present, there is no way to diagnose the condition without conducting an autopsy; in other words, if you’ve got it and you are alive, there is no way for a physician to definitively diagnose the condition. Symptoms include mood changes, aggression, confusion, brain shrinkage and memory loss, as well as a host of other symptoms generally associated with brain damage.
The lack of knowledge surrounding the disease has not stopped companies from addressing it though. The first thing that needs to be done before anything else is diagnosis without an autopsy. Without diagnosis during life, there can be no treatment. Aethlon Medical Inc. (NASDAQ:AEMD) has taken the lead on that front, partnered the National Institutes of Health (NIH).
Details of DETECT Study:
-Blood samples from 78 former NFL players and 16 control subjects were analyzed by Exosome Sciences researchers. Total enrollment should be 94 or higher.
Aethlon’s Exosome Sciences is conducting Alzheimer’s and CTE diagnostic tests. The company has just completed a phase 2 study of its experimental biomarker, TauSome, to investigate its efficacy as a blood based test to diagnose CTE. The trial was conducted in collaboration with the Boston University CTE research center, which recently completed a separate study in which it investigated CTE prevalence in the brains of 91 former NFL players post mortem. The study found CTE in 96% of brains tested – 87 out of the 91 – suggesting CTE has a much higher incidence rate among NFL players than previously thought.
In Exosome’s study, 78 former NFL players were tested, controlled by 16 similar age athletes that participated in non contact sports during their career for a total enrollment of 94 subjects. The science behind the study is rooted in a protein called Tau. Post mortem, physicians detected a larger than expected build up of tau in patients that suffered from CTE, so the theory is that by measuring the amount of tau present in a patient’s blood, a physician can determine whether or not a patient suffers from CTE. We are yet to hear full top-line data, but the trial is completed.
A good hint of what we’ll see with the full data comes from lead physician Dr. Robert Stern who conducted the trial. He has stated that the tausome level is much higher in the former NFL group than the control group, and that the level of tau present correlates with the severity of memory loss.
This was the first research project on CTE ever funded by the NIH, with support from the National Institute of Neurologic Diseases and Stroke (NINDS), the National Institute on Aging (NIA) and the National Institute of Child Health and Human Development (NICHD).
Since there is no current diagnosis tool available for CTE, if Exosome can get its candidate approved, it would be the only player in a large market of retired athletes. Going forward, this could bode well for Aethlon, making the latter an intriguing exposure especially given that a pivotal phase 2 trial is already completed.
Amarantus Bioscience Holdings
Sticking with diagnostics, and also with Boston University, Amarantus Bioscience Holdings, Inc (OTCMKTS:AMBS) is also trying its luck. At the beginning of last year, the company announced the inking of a collaboration with BU to investigate the efficacy of Amarantus’s LymPro dagnostic candidate as a CTE diagnosis tool. The CTE indication is an extension of its primary Alzheimer’s indication. It measures the ability of lymphocytes to withstand external stimulation, but the outcome of this measurement can not determine the severity of a neurodegenerative disease. The CTE indication is still in the very early stage for Amarantus, but if it can get the FDA to approve the Alzheimer’s diagnostic indication which is farther advanced, it could be hot on the heels of Aethlon in getting this tool to market.
Medical Marijuana, Inc.
Moving on to treatment – Medical Marijuana, Inc. (OTCMKTS:MJNA). Kannalife, a company in which Medical Marijuana Inc. holds a 16.7% stake, is investigating the use of cannabis derived therapies for the treatment and prevention of CTE. The company has Marvin Washington, former NFL star in from the 1990’s, as its lead spokesman in a campaign designed to demonstrate the benefit of cannabinoid rooted therapy for not just CTE, but a range of other encephalopathies. Having initially investigated the impact of cannabidiol or CBD, one of the major active ingredients in cannabis, on neural cells in CTE sufferers, the company developed its candidate KLS-109, a drug for which it is hoping to get orphan designation from the FDA.
The drug is essentially an oral formulation of CBD, which has an enhanced bioavailability and central nervous system penetration than cannabidiol in its natural form. Kannalife will initially trial its candidate in a hepatic encephalopathy indication, but plans to expand to CTE soon after. HE occurs when liver failure causes brain damage. This is early days though since the drug has not yet entered clinical trials. When it does, Kannalife would compete with Salix’s Xifaxan – a drug that Credit Suisse estimates will generate $1.4 billion in annual revenues for the HE indication by 2018.
Performance Sports Group
Finally, let’s look at the preventative side of the equation. On November 17, 2015, Performance Sports Group Ltd. (NYSE:PSG) announced its first-in-class technology, designed to reduce the trauma associated with contact sports. The technology is a band that an athlete wears round his or her neck, and it is designed to reduce the amount the brain moves around in the skull in response to trauma. The band lightly squeezes the neck just below the base of the skull, and in doing so, increases the amount of blood that circulates between the brain and the skull. When the head experiences trauma, the increased amount of blood reduces the space that the brain has to move and should restrict contact with the skull and limit the tearing of brain fibers – something that is associated with trauma related brain injuries.
PSG reported the results of two peer-reviewed studies alongside the unveiling of the technology, which suggested that band utilization resulted in an 83 percent reduction in the number of torn fibers in a standard concussion model. The company picked up the rights to the technology from a company called Q30 Sports, LLC back in October, and intends to carry it through the clinical testing phase with the goal of an FDA approval sometime within the next 12-24 months. Since this is a manual preventative, it won’t be subject to the usual rigorous FDA testing process. All the company needs to do is to show it works without posing physical risk to wearers.