by Craig Travis
The problem we solve: Covid-19 is a virus that is transmitted primarily as an airborne pathogen through the upper respiratory tract. As with the other highly pathogenic coronaviruses, SARS and MERS, it is able to breach the normally protective layers of the nose and throat and disable the underlying immune cells. In fact, the immune system itself aids and abets not only the transmission of the virus, but contributes to the overall devastation of the disease process itself known as a cytokine storm.
About our solution: Activation of the cannabinoid type 2 receptors (CB2) of the peripheral endocannabinoid system represents a homeostatic mechanism to counter the effects of the inflammatory response to pathogenic stimuli. Results from an NIH R21 grant for which I wrote the rationale, confirmed that three distinct, non-psychoactive derivatives of THC had a profound effect on the gene expression of vaginal tissue similar to what has been reported in other mucosal tissues and endothelial tissue. These effects can be classified as cytoprotective, i.e. increasing tissue resistance and integrity. The genomic analysis also showed an inhibition of the genes involved in the inflammatory response and upregulation of anti-inflammatory genes, again consistent with the findings in the literature. The nasal administration of the compound that emerges from these studies will help fortify the nasal tissues as well as promote IgA antibody production to prevent the entry and spread of the virus, known as immune exclusionProgress to date:
We have identified four non-psychoactive cannabinoids including CBD and an endocannabinoid known as palmitoylethanolamide (PEA) that have known effects on the immune response that may be beneficial in the setting of Covid-19. A collaboration with Dr. Patrick Hayden of Biosurfaces, Inc. is providing the research platform, i.e. the nasal and lung tissues, on which to test these compounds. We have sufficient quantities of research-grade material for the in vitro studies and eventually for the in vivo studies. We have had discussions with highly respected researchers in academia and the contract research organization space who have indicated a willingness to pursue the research in biosafety level three (BSL-3) facilities if the results of the preliminary studies are promising and if the funding is available. We are negotiating a contract to formulate the lead compound in time to deliver it in the animal studies. I have recently published an article in Frontiers in Immunology that challenges the current vaccine development program with its emphasis on intramuscular administration.
Creator: Craig Travis
Education: Rosalind Franklin University of Medicine and
Bio: I am board certified in Emergency Medicine and practiced for more than 40 years before I retired in 2018. Since then I have devoted all of my energies to Immugen Pharma LLC, a startup biotech company, which I started in 1999. Having practiced in Negril Jamaica from 1988-1994, I experienced first hand the challenges of healthcare delivery in a developing country, particularly the cost of HIV drugs that has motivated me to develop a low cost alternative for the prevention and treatment of HIV. Also, as a result of the horrendous trauma that I witnessed there, I helped to coordinate an ad hoc working group with representatives of the insurance industry, Ministry of Health, Fire Brigade and rehabilitation center to provide a framework for the establishment of the island’s first emergency medical system whose prototype was launched in the parish of Westmoreland where Negril is located. I also witnessed the environment coming under assault from tourism, overfishing and lack of planning. The founding of the Negril Coral Reef Preservation society took place on the veranda of our home. Likewise, I helped the fishermen of Negril to re-establish their cooperative in order to engage them in the restoration of the marine environment. Today, Negril has a marine park. I have been married for nearly forty years and have three grown children.
Title: CEO and President
Advanced Degree(s): M.D.
Chief Financial Officer, BS
Biography: In addition to serving as Immugen's Chief Financial Officer, David founded and has served as Chief Executive Officer of ALDA & Associates International, a management services firm focused on life sciences and healthcare since its inception in January 1993. Since 1993, his experience resulted in the development of broad relationships with physicians and physician groups across the country. Prior to the formation of ALDA he was an international business advisor to senior management and boards of directors as a senior international partner during a 24-year career with Ernst & Young from January 1969 to December 1992. His book Essentials of Corporate and Capital Formation was recently published by Wiley & Sons. David is a Certified Public Accountant.
Title: Chief Financial Officer
Advanced Degree(s): BS
Bill Massey, Ph.D.
Chief Regulatory Affairs Officer, Ph.D.
Biography: Dr. Massey is a neuropharmacologist, pharmacogeneticist, life sciences professional, senior executive and entrepreneur. Dr. Massey received his Ph.D. in Pharmacology at the University of Arkansas for Medical Sciences and subsequently was an investigator at the Pritzker School of Medicine’s Drug Abuse Research Center at The University of Chicago. Dr. Massey holds long-standing adjunct faculty appointments at the University of Arkansas for Medical Sciences (Associate Professor, Dept. of Pharmacology and Interdisciplinary Toxicology) and the University of Mississippi Medical Center (Clinical Assistant Professor, Dept. of Psychiatry). Dr. Massey has previously held leadership positions at Merck, Astra Merck, Quintiles, Scirex, Astra Zeneca, Scientific Commercialization, Litmus Molecular Design, SureGene, and GeneAlign. He has played a leadership role placing 28 new drugs into human testing and in bringing 8 new drugs onto the market. Dr. Massey held the Jack Martin, MD Research Professorship in Psychopharmacology at Vanderbilt University, where he conducted research into the genetics, biological basis and pharmacological treatment of schizophrenia and serious mental illness in collaboration with Dr. Herbert Y. Meltzer. Dr. Massey has also served as Chief Science Officer at Opiate Treatment Centers of America. In addition to his position with CadiraMD, Dr. Massey is currently a Visiting Scholar at the Feinberg School of Medicine’s Dept. of Psychiatry and Human Behavior at Northwestern University where he continues his research collaboration with Dr. Meltzer.
Title: Chief Regulatory Affairs Officer
Advanced Degree(s): Ph.D.
Vice-President, Research - Biosurfaces, Inc. , Ph.D.
Biography: Pat is a senior scientist with nearly forty years experience in culturing tissues for the research community. When I approached him regarding a collaboration, he enthusiastically endorsed the effort and has been steadily been working to deliver the nasal and endothelial/alveolar (airway) tissues needed for this research.
Title: Vice-President, Research - Biosurfaces, Inc.
Advanced Degree(s): Ph.D.
Our product is a drug with very specific indications - either it will be used as a primary treatment for a viral infection such as the deadly Covid-19 virus or it will be used to boost vaccines that can be given intranasally. Clearly, if it can reduce the symptoms and speed recovery, then it will be of benefit to all patients. Further studies will be necessary to determine if it has value in other respiratory infections such as influenza or even, the common cold.
Ever since the discovery of the endocannabinoid system and the role that it plays in the immune system, researchers have been hypothesizing and then studying the effects that various compounds, i.e. ligands that are selective for the CB2 receptor have. Unfortunately, this class of compounds has not been put to a real-world test except in the case of medicinal cannabis and CBD where the indications are very broad and based on anecdotal evidence. My original research objectives were directed at HIV prevention and treatment, but without further funding, I have not been able to achieve that goal. However, given that we are currently in a health crisis that has not been seen for more than a hundred years, I feel very strongly that we need to pull all the stops and establish what value that these compounds have.
The outpatient treatment of Covid-19 should decrease the demand for hospital-based interventions. However, based on a study in mice exposed to a lethal dose of a bacterial endotoxin, all of the mice that were treated with THC survived whereas those that did not develop acute respiratory distress syndrome (ARDS) and died. Since most patients that are admitted to ICUs with severe acute respiratory syndrome (SARS), the early administration of our lead compound that is a synthetic derivative of THC may, in fact, prove to be superior to dexamethasone in preventing the progression of the cytokine storm responsible for the condition and help to restore homeostasis that is the primary function of the peripheral endocannabinoid system.
Whether shareholders or patients, we are all stakeholders in this process. By transitioning from a natural product that has been in human use for more than 10,000 years into a pill or spray or suppository without the psychoactive effects to treat a variety of medical conditions is clearly a great benefit to all of humanity. Our goal is to keep the costs down to make the drug affordable to those who need it. Given the potentially massive demand for the drugs across all indications, small profit margins will nevertheless translate into substantial rewards. Crowdfunding will play an important role in the early stages of this venture.
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