Biopharmaceutical Approach

Our approach is based on three areas: a) prevention; b) identification; and c) treatment of Chronic Traumatic Encephalopathy (CTE).  We have filed and in-licensed intellectual property/patents related to these areas and are at various stages of development for products in each of these areas. 

Prevention: Through a license agreement, we have exclusivity for the patented product NeuroStilbene™.  This product has been demonstrated to prevent brain inflammation, one of the principle causes of CTE initiation and progression. We are currently working through a variety of industry and academic collaborators at developing add-on preventative products based around inhibiting microglial reactivity, the cause of brain inflammation.  
 
Identification:  Currently the only definitive means of diagnosing CTE is by looking at the brain after the patient has passed away.   Dr. Thomas Ichim, a minoriis one of the pioneers of the emerging field of exosomes.  These small particles are generated by the brain and may be used as a blood based means of assessing what is occurring in the brain.  We have filed patents related to exosome-based CTE diagnosis, as well as integrating this approach with functional MRI imaging.  Through developing and implementing early, non-invasive diagnostic means, we aim to eventually provide personalized treatments that possess the highest probability of success.  Additionally, through employing genespecific tests, we can predict susceptibility of patients to development of CTE.  Testing for genes, such as the IL-6R CC, which are known to be associated with 3 times the concussion risk, and other genes is not available to players and their families.  We will make it available.  

Treatment: In contrast to the historical viewpoint that the brain cannot regenerate, recent findings suggest otherwise.  Therapeutic approaches ranging from stem cells, to gene therapy, to small molecule activators of endogenous regenerative cells, have all demonstrated therapeutic benefit in animal models and early human clinical trials.  Our work is focused on integrating all available knowledge on CTE and previous studies on neuroregeneration in order to develop an optimized protocol.  Given that CTE appears in some ways to be an accelerated form of Alzheimer’s Disease, treatments developed by us and associated patents can be leveraged in the Alzheimer’s field, which possesses higher valuation. 

WesCell

WCTE is in the process of developing an Investigational New Drug (IND) application to the FDA for using WesCell™ for treatment of CTE.  WesCell™ is a type of stem cell which has previously been shown safe in early human trials for other conditions.  Data by WCTE and others suggests that WesCell™ possesses superior efficacy to other adult stem cell types in terms of stimulating formation of new brain cells, as well as protecting existing brain cells from dying.  

Therapy with WesCell™ involves intravenous administration of the cells in patients suffering from advanced CTE.  Initial clinical trials are planned to assess efficacy of the new stem cell in terms of reducing brain inflammation and stimulating enhanced brain connectivity and regeneration

Subsequent to FDA clearance to initiate clinical trials, we believe some patients will have accelerated access to this therapy through the Right to Try Law which allows no option patients access to interventions shown to possess basic safety features.   
 
Small molecule drugs are not typically regarded as biopharmaceutical in nature by the industry. However, it has been said that members of the press and the business and financial community often extend the definition to include pharmaceuticals not created through biotechnology. That is, the term has become an oft-used buzzword for a variety of different companies producing new, apparently hightech pharmaceutical products.  When a biopharmaceutical is developed by WCTE, it will apply for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which WCTE can recover the investment cost for development of its biopharmaceutical

Being Researched

As part of our collaboration, Dr. Santosh Kesari, PhD at John Wayne Institute will lead our scientific team in the participation of a new clinical trial looking at the restorative properties of stem cells and how they can help all participants in WCTE recover from Traumatic Brain Injury (TBI). The most common type of TBI is concussions defined as a head injury with transient disturbance in the brain function (e.g. loss of consciousness and altered mental status). The TBI clinical trial involves the use of bone marrow, derived from modified stem cells, as repair agents. The investigational stem cells, called SB623, are derived using a highly specialized, minimally invasive neurosurgery procedure using computer guidance to target the site of an injury (such as the inability to move an arm or leg) with the aim of helping resolve and reverse the symptoms. Using minimally invasive neurosurgery for precise stem cell delivery to specific regions of the brain, we believe we will see the benefits through the healing qualities of these cells.