Developing Nature-based, Preventive Medications
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PreveCeutical Medical Inc. (CSE:PREV, OTCQB:PRVCF, FSE:18H) is an early-stage biotechnology company focused on the development of preventive and curative therapies. The company has partnered with the Pharmacy Australia Centre of Excellence (PACE) at the University of Queensland on their research and development (R&D) projects. The projects focus on developing a cannabidiol administrative device and program, a dual gene therapy program focusing on preventing type 2 diabetes and obesity and a peptide therapeutic program focusing on developing non-addictive analgesics for acute and chronic pain.
In 2015, more than 33,000 Americans died as a result of an opioid overdose and 22,000 of those overdoses involved prescription opioids. In Canada, 2,800 people died from opioid use in 2016. Opioids are usually prescribed as painkillers under brand names such as OxyContin®, Percocet® and Vicodin® among others, however it can also be obtained illegally as heroin or fentanyl.
Many pharmacology companies and patients are looking for alternative treatments to opioids for dealing with acute or chronic pain. A number of pharmaceutical companies are looking towards the cannabis product cannabidiol (CBD) to help wean people off of their addictions as an alternative to using opioids. The medicinal and non-psychoactive component of cannabis, CBD does not give users the ‘high’ that is associated with cannabis consumption and has less addicting properties due to the absence of tetrahydrocannabinol (THC).
PreveCeutical is currently conducting a R&D project involving the use of CBD. Its Sol-gel system is intended to deliver the therapeutic compound to a targeted diseased site at a slow, controlled rate through the nose. Medications absorbed nasally can rapidly and directly enter the brain through the olfactory mucosa. The solution that is administered starts out as a liquid and then forms into a gel when it comes in contact with mucosal tissue. The solution will last up to seven days and slowly releases the compound in the solution to target particular areas of pain. Currently, PreveCeutical is in exploratory discussions with pharmaceutical and biotechnology companies developing therapies for neurological disorders that are looking for a nose-to-brain drug delivery system with the intent to form a partnership for the co-development of Sol-gel.
In July 2018, PreveCeutical launched its CBD division which will focus on finding treatments for various ailments using CBD which can be administered through the Sol-gel delivery system. The division has been tasked with finding a treatment for anxiety.
The company is also conducting additional R&D projects with focus on dual gene therapy and engineering peptide therapeutics. The first focuses on using gene-silencing technology that ‘turns off’ genetic signals, which could, for instance, represent a cure for type 2 diabetes and could potentially stop the disease from materializing.
PreveCeutical is led by an experienced management team. The company’s Chief Research Officer, Harry Parekh, specializes in developing highly innovative and translational medicine delivery systems in conjunction with physicians whose expertise spans cancer, obesity, diabetes, macular disease, infectious disease and traditional medicine. Management and insiders are notably invested in the company, holding 49 percent of the shares.
- Highly differentiated portfolio of novel compounds and products.
- In discussions to develop co-development partnerships for Sol-gel technology.
- Cannabis Division is developing an anxiety treatment formula that will use their Sol-gel delivery device.
- Research and development relationships with established and reputable university-sponsored scientific team at the University of Queensland in Australia.
- Lucrative market for preventive healthcare, which is valued at $196.9 billion by 2024 and is growing by 15 percent annually according to analysts at Grand View Research.
Many potentially valuable drugs for treating neurological disorders are unable to reach the brain in sufficient concentration to be therapeutically valuable because of the blood-brain barrier. Intranasal delivery of therapeutic agents is one method to bypass the blood-brain barrier in a non-invasive manner.
In April 2017, PreveCeutical signed a R&D agreement with PACE to conduct a research program for the extraction, formulation and evaluation of CBDs for local and direct nose-to-brain delivery via Sol-gels. The duration of the project is approximately 30 months and will encompass fractionation and analysis of plant-derived CBDs, formulation of soluble gels infused with CBD extracts and perform CBD fraction delivery studies from lead Sol-gel formulations.
“Working with UniQuest and the University of Queensland on this research program provides PreveCeutical with unique opportunities towards developing products that promote good health and wellness, said PreveCeutical President and CEO Stephen van Deventer. “Nasal delivery of CBDs will potentially provide a safer and reliable delivery platform with clinical benefits that include benefits for pain, inflammation, seizures, and mental illness.”
Part of PreveCeutical’s R&D program includes testing and formulating a variety of cannabis strains for its Sol-gel technology. To date, the company has developed an inhalation model for Sol-gel which mimics the inhalation action performed by patients when using nasal sprays. This allows the Sol-gel formulation to reach into the upper nasal cavity which is adjacent to the olfactory epithelium and serves as a direct passage to the brain.
“This is an important development for PreveCeutical, having demonstrated that its engineered Sol-gels and applicator device achieve delivery and retention directly at target tissue high in the nasal cavity, a feat that cannot be claimed by liquid sprays existing in the market currently. What’s more exciting is that this outcome opens the door for PreveCeutical to potentially deliver a host of therapeutics from nose-to-brain in a reliable and sustained manner, which remains a significant challenge for many companies, globally,” PreveCeutical’s Chief Research Officer Dr. Harry Parekh.
Currently, PreveCeutical is in exploratory discussions with pharmaceutical and biotechnology companies developing therapies for neurological disorders that are looking for a nose-to-brain drug delivery system with the intent to form a partnership for the co-development of Sol-gel.
How it works
The nose-to-brain pathway is lined with mucosa that are in direct contact with the brain and cerebrospinal fluid. Medications absorbed across the olfactory mucosa can rapidly and directly enter the brain. Being able to bypass the gastrointestinal tract can avoid causing digestive side effects and upset and offers enhanced targeting and reduced systemic side effects often found in pharmaceutical compounds. Nasal delivery also provides a predictable absorption timeline, which is not dependent upon gastric processes.
The Sol-gel system is intended to deliver a therapeutic compound to a targeted diseased site at a slow, controlled rate. The solution starts in a liquid state when administered to the nasal passage where it rapidly turns into a gel state upon contact with mucosal tissue. The gel then stays in place and slowly releases the compound that was in the solution. The solution can remain active for up to seven days.
In July 2018, PreveCeutical announced that it had created a medical cannabis division, which will be responsible for bringing an array of high-quality, medicinal cannabis-based products to the market. The division will also be responsible for overseeing the Sol-gel research program and the formulations created. Through these products, PreveCeutical plans on addressing a number of ailments including chronic pain, epilepsy, anxiety disorders, among others.
Anxiety Treatment Products
One in 10 Canadians will suffer from an anxiety disorder in their lifetime, according to the Government of Canada. Anxiety disorders are mental disorders that are characterized by feelings of anxiety and fear and can include the following disorders: generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive-compulsive disorder and post-traumatic stress disorder. Symptoms can range from mild to severe and the duration of symptoms will classify them as either chronic or episodic.
Anxiety disorders are often taxed with social stigma, which can make obvious or frequent administration of medications undesirable for patients. PreveCeutical’s Sol-gel product development program aims to create an effective, subtly administered cannabidiol in a sustained, low dose, enabling it to be administered as infrequently as once every few days.
CBD is one of hundreds of cannabinoid strains found in a cannabis plant and lacks the psychoactive properties that THC is known to have. When consumed, cannabinoids bind to special cell receptor sites throughout the brain and body. This indicates that CBD has a range of medicinal uses, including providing relief for pain, inflammation, seizures and neurological disorders. CBD appears to be capable of communicating between cells, which can help improve the natural endocannabinoids that our bodies produce.
The cannabis division’s first goal is to develop an effective therapy for anxiety that can be administered subtly and infrequently through the company’s PreveCeutical’s Sol-gel technology.
Dual Gene Therapy
It is estimated that by 2022, the global diabetes care and therapeutics market could reach $85.5 billion due to the increasing rate of diabetes driving the growth of the market. Sedentary lifestyles and improper diets are contributing to the rising diabetes rates and triggering diabetes.
Two new drug classes have been developed in order to improve glycemic control while also reducing weight and they are gaining momentum in an insulin dominated market. Unfortunately, these drugs do not address the long-term progression of the disease, which has sustained the need for more research to be conducted.
Gene therapy involves the substitution of defective genes in a cell with genetically-altered genes. Defective genes can trigger malfunctions within metabolic pathways, which can lead to diseases such as cancer or diabetes. Gene therapy could help patients suffering from diseases who only manage their symptoms through medicinal means.
Gene therapy relies on vectors to carry the normal genes and transfer them to the cells that have the defective genes. Viruses are popular vectors, but there are drawbacks to using them. For instance, there is no guarantee that the viral enzyme will be able to introduce the normal gene at the right point in the diseased cell. Additionally, there is always the possibility that the body will kill the vector because it is an unwanted foreign body, causing the patient to undergo multiple treatments to achieve a cure.
There are other options for introducing vectors. They can be introduced with the use of liposomes and naked DNA. Liposomes are tiny bubbles made out of the same material that cell membranes are made out of. Naked DNA refers to DNA that is not associated with proteins and lipids. They are the release of genetic information into the surrounding environment.
Smart siRNA project
In July 2017, PreveCeutical entered into a research and option agreement with PACE who will conduct a research program to focus on the development of smart siRNAs, also known as small interfering ribonucleic acids or silencing RNA (siRNA), for the treatment of type 2 diabetes and obesity. The program builds on years of multi-disciplinary R&D in diabetes and obesity and will pursue a dual-gene therapy strategy using bio-nanotechnological approaches. The program will be conducted in three phases over a period of up to four years.
The company has put five different genes, which are implicated in obesity and diabetes, on a target short-list. The first steps of the program will involve protein sequencing and peptide synthesis. The team believes that it can overcome the key shortfall in gene silencing through the use of a non-viral delivery vehicle. They plan to use vectors that are chemically derived from a naturally occurring substance.
Silencing RNA is a class of double-stranded RNA molecules. SiRNA interferes with the expression of specific genes by degrading microRNA (mRNA). Degrading mRNA prevents translation, which is a critical step in cell replication.
The ability to silence specific genes using siRNA has wide therapeutic applications. The use of siRNA in drug therapies begins with the design of siRNAs, which will target the part of the protein that causes the disease. Then the siRNA is included in a delivery vehicle that will take it to the diseased tissue site.
“With diabetes, over-production of a particular protein molecule has been identified and thought to be responsible for the key drivers of diabetes and obesity, starting patient on an inevitable journey of significant co-morbidity and increased rates of mortality,” said Parekh. “PreveCeutical’s gene-silencing technology would effectively “turn off” the genetic signal which leads to the overproduction of this key protein molecule, bringing it back down to safe, normalized levels; this would in turn help our cells to absorb glucose, thus reducing blood sugar levels and prevent the body from storing excessive fat from our diet. Thus gene-silencing does not represent a mere management for diabetes and obesity, it represents the potential for a bona fide cure or, in cases where patients have a predisposition to diabetes or are in the prediabetes state, it can be applied as a ‘PreveCeutical’ to halt progress to the full-blown disease.”
In October 2018, PreveCeutical’s research team at the University of Queensland held a two-day intensive workshop with teams from QIMR Berghofer Medical Research Institute in Brisbane and Murdoch University in Perth to collaborate on the company’s dual gene therapy program. The objective of the workshop was to share data collected to date on gene engineering, delivery system design and synthesis as well as their evaluations of cellular models for diabetes and obesity.
The teams created a 10 to 12-month plan to conclude the current phase of the program with a proof-of-concept demonstration for the delivery of smart siRNAs and in-cell modulation of key biomarkers implicated in diabetes and obesity. Once this phase is complete, PreveCeutical will move towards preclinical trails to test the efficacy and safety of their siRNA program.
To date, PreveCeutical has identified four novel siRNA constructs that target the gene of interest and is able to reduce it by 80 percent when compared to a random siRNA control sequence.
“This is an important development in our dual gene therapy program, as the identified sequences are a fundamental piece in the gene therapy approach to potential applications for diabetes and obesity, representing the ‘medicine’ component of the proposed therapy. With the blueprint for novel, potent sequences in-hand we can now focus our efforts on refining them to improve characteristics important to their potency in vivo,” said Dr. Parekh.
Peptide Research and Development Projects
Peptides are currently being used to target an array of disease indicators including metabolic disorders, pain, cancers, cardiovascular and infectious diseases. The therapeutic peptide market is projected to undergo considerable expansion in the foreseeable future as technologies to enhance their stability and bioavailability emerge.
In April 2017, PreveCeutical and PACE signed a research and option agreement for conducting a research program for the development of scorpion venom-derived natural and synthetic peptides. They would like to identify the peptides that are providing immune boosting and tumor-selective painting properties, access synthetic versions of the active peptides and ultimately identify other therapeutic applications for the blue scorpion venom and/or active peptides.
PreveCeutical and PACE are currently screening peptides isolated from Caribbean blue scorpion venom across some of the most aggressive diseases, such as cancer. There are numerous research papers which show the anecdotal findings and efficacy of venom peptides that have been administered on cancerous cells and tumors.
Engineering peptide therapeutics
In August 2018, PreveCeutical and PACE entered into a research and option agreement in which the two companies agreed to conduct a research program that will expand the use of their disulfide linker technology and seeks to develop non-addictive analgesics for the treatment of pain, which may offer an alternative to addictive opioids. The multiphase research program will involve a peptide library synthesis pharmacological evaluation and acute pharmacokinetic assessment and efficacy determinations in appropriate models for pain and inflammation.
“Our preliminary work has highlighted that by using our proprietary linker technology we can enhance stability while maintaining, and in some cases enhancing the potency of lead bioactives,” said Dr. Parekh. “Having PreveCeutical on board will accelerate our current program, allowing us to rapidly expand and screen the bioactive library, taking the most promising candidates through to efficacy and pharmacokinetic evaluation.”
Stephen Van Deventer — Chairman and CEO
Stephen Van Deventer is an experienced business person and corporate director. Specializing in international corporate relations and business development over the last 25 years, Van Deventer has focused on launching small to medium-sized companies into the public markets in Canada, the United States and Europe. He has also owned and operated private businesses.
Dr. Makarand Jawadekar, Ph.D. — President and CSO
Dr. Jawadekar previously spent 28 years working at Pfizer Inc., where he served as Director of Portfolio Management. During his Pfizer tenure, he was a bench scientist for the formulation of the blockbuster drug, Zoloft (sertraline). Dr. Jawadekar was also involved in Pfizer’s external drug delivery technology assessment function and applying unique drug delivery systems into the company’s novel products.
Dr. Jawadekar is a member of the Board of Directors of New York-based non-profit Abilities Inc. He serves on the strategic advisory boards of numerous pharma, biotech, drug delivery technology and nutraceutical companies. Dr. Jawadekar earned his Ph.D. in Pharmaceutics from the University of Minnesota in 1982.
Shabira Rajan, MBA, CPA, CGA — CFO and Controller
Shabira Rajan is a senior financial executive with over 20 years of experience, leading the financial discipline for successful businesses in both private and public sectors. She has a track record of providing leadership for strategic value creation and continuous improvement, as well as, providing effective direction to organizations on issues relating to corporate governance, financial oversight and risk management. One of her leadership roles was that of Director of Finance at Canada Line Rapid Transit Inc., which planned and constructed a $2 billion rapid transit system in metro-Vancouver, on time and within budget.
Harry Parekh, Ph.D., MRPharmS — Chief Research Officer
Based at the University of Queensland’s (UQ) Pharmacy Australia Centre of Excellence (PACE), Dr. Parekh also holds adjunct positions at the National University of Singapore, and Manipal University, India. Dr. Parekh heads the Drug & Gene Delivery Group at PACE-UQ with his team where they’re developing highly innovative and translational medicine delivery systems in-conjunction with physicians whose expertise span cancer, obesity and diabetes, macular disease, infectious disease and traditional (Chinese) medicine.
Alicia Rebman — Marketing Director
Alicia Rebman is a marketing professional with a background in publishing technologies, communications, and graphic design with a specialty in branding and communications for social enterprises and NGO start-ups. Rebman ran a successful design services company for six years before heading the marketing department for the global office of Hartley & Marks Group, an international design and publishing company.
Susan Blond — Director of Publicity
Susan Blond started her career painting with The Whitney Museum studio program, but once she got a job at Andy Warhol’s Interview, life was too exciting for her to paint. She sold ads primarily to record companies and the magazine took off. She then went on to United Artists and Epic/CBS Records where she became the first woman VP in the whole industry.
The artists she represented were Michael Jackson, Boy George, Sade, the Clash and countless others. She formed Susan Blond Inc in 1986 where she not only represented Usher, The Spice Girls, and Morrissey, but companies such as The Hard Rock Cafe, Sports Club LA (now Equinox) and executives like Charles Koppelman and Clive Davis. Susan serves as Secretary of the Board of DIFFA: Design Industries Foundation Fighting AIDS.
Deanna Kress — Director of Communications and Investor Relations
Deanna Kress has been involved in public capital markets since 2003 with a focus on investor relations and corporate communications. Kress has a wide-range of experience with a number of exploration and production companies listed on both the TSX Venture Exchange and the Toronto Stock Exchange.
She has led various marketing initiatives with public and private company management teams to assist with equity financing, to secure coverage from all sectors of the investing community, and to implement internal procedures to ensure clear and effective communication to stakeholders. Kress holds a Medical Assistant Diploma and is in the process of completing a Health Sciences Degree.
Greg S. Reid — Director
Filmmaker and Keynote Speaker, Greg S. Reid, is a number one best-selling author, entrepreneur, and the CEO of several successful corporations, who has dedicated his life to helping others achieve the ultimate fulfilment of finding and living a life of purpose. In addition to being published in over 35 books and Featured on Nationally Syndicated programs across the U.S., he is also the creator and producer of the internationally acclaimed films Pass It On, and Three Feet from Gold.
Matt Coltura — Director
Matt Coltura has a Bachelor of Business Administration from Okanagan College where he specialised in finance. He has worked in the finance industry for over three years with a primary role in writing credit for potential borrowers in the industrial lending market. Currently, Coltura is the CFO of Cayenne Capital Corp. and sits on the board of directors for Stoneridge Exploration.
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