Welcome to ValiantCEO Magazine’s exclusive interview with Roger DuMoulin-White, President and Chief Executive Officer of Theralase® Technologies Inc. In this captivating discussion, Roger opens up about what led him to pursue the destruction of cancer.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds and their associated laser systems with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.
Roger dives into the challenges of pursuing the destruction of cancer and shares insights on how he navigated the path and what it took to move closer to this lofty objective. Drawing from the path he has travelled and still travels today, he sheds light on just how difficult this objective can be and what can be garnered by the failures along the road.
Roger highlights Theralase®’s accomplishments in the past few years with a keen focus on commercializing Theralase®’s unique cancer treatment for various oncological targets. Roger presents what the future may hold, if this technology achieves regulatory approval.
Join us for an illuminating conversation as Roger shares his expertise on Theralase®’s technology and the road to “Destroying Cancer at the Speed of Light®”.
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Table of Contents
We are thrilled to have you join us today, welcome to ValiantCEO Magazine’s exclusive interview! Let’s start off with a little introduction. Tell our readers a bit about yourself and your company.
Roger DuMoulin-White: My name is Roger DuMoulin-White and I am the President, CEO and founder of Theralase® Technologies Inc., a clinical stage pharmaceutical company that is dedicated to the research, development and commercialization of specially designed light-sensitive molecules that have a proven affinity for cancer cells and the light systems that activate them to destroy cancer.
How did you get started with Theralase®?
Roger DuMoulin-White: I have always had a burning curiosity to try to understand how things worked, ever since I was a young boy. This led me into the STEM (Science, Technology, Engineering and Mathematics) courses during high school and eventually into learning tool and die making part-time, during the summer months.
I remember a computer science course I took in Grade 10 and the keyboard for the personal computer was sticky (someone must have spilled their soft drink on it) and every time you pressed a key, two characters would appear on the screen.
My solution would have been to disassemble the sticky keyboard and clean it, but instead my computer teacher wrote and installed a software program on the computer that automatically deleted one of the characters, whenever two identical characters appeared, within a certain time frame.
It was then and there that I realized the impact that computers and their associated software were going to have on the world, when simple software code was able to overcome a mechanical problem. This was the 70’s and computers were just starting to expand from performing simple tasks via punched computer cards to more powerful home-based personal computers.
Always yearning to understand how things worked, I decided to pursue a degree in electronics, graduating as an electrical engineer from the University of Western Ontario, in 1986. Upon graduation, I pursued a career in automotive electronics working for Ford Electronics Manufacturing Corporation, a division of Ford Motor Company in Toronto, Ontario.
Ford Electronics produced the electronic assemblies used in the manufacture of Ford vehicles and in my particular division, we manufactured electronic speedometers, electronic radios and the air bag systems, used for passenger safety during accidents.
I worked hard during my tenure and was promoted rapidly, until I became a Product Team Manager, running a $CAN 30 million dollar a year operation for Ford, managing the population of printed circuit boards with millions of electronic components, annually. I had 12 direct employees and over 375 indirect employees reporting to me in this operation.
Over the years, I saved Ford millions of dollars with my quality improvements and innovations, but I knew in my heart that I would never earn this kind of money for myself if I stayed at Ford, so I decided to resign my position in the fall of 1994 and pursue a new career, one that I could call my own.
My father a few years earlier had introduced me to the inventor of a new kind of laser system, called a therapeutic laser or “Cool Laser Therapy” that had the ability to use laser beams at specific wavelengths to reduce inflammation, eliminate pain and accelerate tissue healing in human pain conditions, with no side effects.
In the summer of 1994, before I resigned my position at Ford, I flew to Belgium to meet with the inventor and became so fascinated with the technology that I decided to negotiate the worldwide exclusive rights to the technology and flew back to Toronto, Ontario to start my own company, which I named Future Solutions Today.
Future Solutions Today, an Ontario based company, eventually became Theralase® in 1995, when I created a federally incorporated company. I now set my sights on redesigning the Cool Laser Therapy technology for commercial applications in Canada and the United States.
Being the first and only employee of Theralase®, I was tasked with the management, engineering, production, marketing and sales of my new venture. My engineering skills came from Western, my management and production skills came from Ford. I was an extroverted individual, who enjoyed speaking with new people, so my marketing and sales skills came naturally.
It took 5 years of hard work and a significant number of setbacks, but I eventually built the company into a multi-million-dollar business designing, manufacturing and selling this Cool Laser Therapy technology to chiropractors, physiotherapists and veterinarians across the world.
One of the main setbacks I faced was being a company with a single employee, as I quickly realized how long it took to accomplish various tasks.
My solution was simple and I had learned it from my mom, “If you want to accomplish something, try to do a little bit each day.” I set out to accomplish at least one significant task per day and in this sense, I could accomplish 200 to 250 significant tasks per year.
Eventually, after generating revenue, I was able to afford to hire people and I tried to instill this thought process into them, as well. Sometimes it worked, sometimes it didn’t. What I learned very quickly was that managing employees was a full-time job, as it was as much an art, as it was a science.
How did you pivot Theralase® into oncology?
Roger DuMoulin-White: In early 2000, I read an obscure article in Laser Focus World, an industry trade magazine, about a chemistry professor based in the United States, who had just commenced development on a new light sensitive molecule, that she had discovered to have an affinity for cancer cells.
When this molecule had localized to cancer cells, it possessed a photosensitive key that could be light activated to destroy those specific cancer cells. I became fascinated with the potential of this new technology and I wrote to her to better understand her research.
She mailed me her published research and for the life of me I couldn’t understand it, as the chemical formulas were complex formulations 20 to 30 characters long. Being an engineer, I conducted my due diligence by researching the technology and after a few years I was able to understand it much clearer.
In 2003, just after completing a reverse take over to take Theralase® public on the Toronto Stock Exchange – Venture, I flew to Blacksburg, Virginia and negotiated the worldwide exclusive licensing rights to this new technology and promptly set out to research, develop and hopefully commercialize this technology.
I researched the lasers to activate this newly synthesized Photo Dynamic Compound (“PDC”), as well as financed all operations, the chemistry professor (in conjunction with a biology professor) developed new variations of the PDC compounds and I commenced working with a physicist at the world-renowned cancer hospital in Toronto; named, Princess Margaret Cancer Center (“PMCC”), to test the PDC on cancer cells using various experiments.
How did the initial research and development into the PDCs go?
Roger DuMoulin-White: The team, initially comprised of an engineer, a physicist, a chemist and a biologist pursued this PDC research and development for seven years, when the physicist, myself and a recent Theralase® employee, a medical doctor by training, came to the conclusion, that although these PDCs were effective at destroying cancer cells, possessing so-called high “light toxicity” (activity in the presence of light), they also possessed extensive “dark toxicity” (activity in the absence of light), which would render them toxic to healthy tissue, when introduced to the human body.
This technology although effective in destroying cancer cells, would also therefore be toxic to healthy cells, which would prevent its commercialization for oncological conditions.
What happened next?
Roger DuMoulin-White: Fortuitously for Theralase®, the chemistry professor, the biology professor and myself won one of the 2010 Popular Mechanics Awards for one of the top 20 technologies in the United States that could “Change the World”. I flew to New York in the summer of 2010 and I accepted the award on behalf of Theralase®.
There was significant marketing promotion of the event in Canada and the United States and serendipitously another chemistry professor heard the news and decided to contact me to inform me that she was also researching and developing novel PDC technology and wondered if I would be interested in investigating her technology.
By this time, I was much more knowledgeable of PDC technology and under a confidentiality agreement, I reviewed her research.
I thought that her technology had great promise and in 2011, I negotiated the worldwide exclusive licensing rights to her PDC technology, in-licensing her main platforms; specifically, a Ruthenium-based platform and an Osmium-based platform, comprising millions of various PDC compounds in a Markush structure (a group of related chemical compounds).
How did this next set of PDC platforms work out?
Roger DuMoulin-White: Myself and Theralase®’s newly hired Chief Scientific Officer, the medical doctor, again working with the physicist at PMCC, worked diligently to research and develop these new PDCs, with our newly found chemistry professor.
In the process, Theralase® developed a comprehensive patent portfolio, which consists of 46 issued patents, 23 patents pending and still counting. We conducted a systematic review of this latest batch of PDCs and we ended up liking one of the compounds in particular, a ruthenium-based compound, we named TLD-1433, due to its molecular structure.
Over the next 7 years, we proceeded to take TLD-1433 through drug discovery, preclinical testing, toxicology and a “first in-man” Phase Ib clinical study for Bacillus Calmette-Guérin (“BCG”)-Unresponsive Non-Muscle Invasive Bladder Cancer (“NMIBC”) patients wrapping up in 2018.
The Phase Ib clinical study was very successful demonstrating that the technology was safe and effective for patients, with little to no side effects and more importantly zero toxicity, the pharmacokinetics (how the drug interacts with and leaves the body) were extremely favourable, leaving the body within 72 hours of dosing through normal processes and most importantly it demonstrated a clear efficacy response in the patients treated at the therapeutic dose, destroying their bladder cancer.
What have been the key milestones and results of Theralase®’s Phase II NMIBC clinical study, particularly focusing on the efficacy and safety of TLD-1433?
Roger DuMoulin-White: Theralase®, under the recommendation of its medical and scientific advisory board commenced a pivotal Phase II NMIBC clinical study in late 2019 with efficacy as its primary objective. To date, Theralase® has treated 59 patients and the clinical data has been nothing short of amazing, demonstrating world-class efficacy in the destruction of BCG-Unresponsive NMIBC Carcinoma In-Situ (“CIS”).
TLD-1433 has demonstrated a 66% Complete Response (“CR”) (negative cystoscopy (no cancer in the bladder) and a negative urine cytology (no cancer in the urine)) at any point in time and a 33% duration of CR at 12 months after initial CR assessment. For a single agent, this is one of the strongest clinical data sets produced to date for this disease.
There have fortunately been no serious adverse events directly related to the study drug (TLD-1433) or study device (TLC-3200 – laser used to activate TLD-1433), proving its safety, in addition to it efficacy.
The clinical study is currently ongoing and is expected to be completed in 2026; hopefully, leading to commercial approval by Health Canada and the FDA. This may in turn hopefully lead to widespread clinical adoption of this technology by the medical community.
Why is cancer so hard to destroy?
Roger DuMoulin-White: Let’s start with a biology lesson. Cancer cells are just like every other cell in your body, depending on type. There are approximately 37 trillion cells in your body with approximately 200 different types of cells.
Cancer cells have one very important, subtle difference versus healthy cells; their DNA has been damaged and as a result they fail to die when they are supposed to, a process known as apoptosis or natural cell death. Because of their refusal to die when they were supposed to as they were programmed, when they divide and multiply (a process known as mitosis), their offspring cells also possess the damaged DNA and refuse to die.
This process continues until the rogue cancer cells multiply sufficiently to become a mass (commonly referred to as a lump), where they eventually overtake blood vessels, lymph nodes, organs and if not stopped dead in their tracks, the human host. The rate, at which they multiply, determines how “aggressive” the cancer is and how quickly it may kill the host.
The medical community has its “trilogy” of standards of care for cancer; specifically: surgery (where the surgeon tries to remove the cancer by cutting it out), chemotherapy (where the patient is injected with powerful cytotoxic (cell killing) drugs to try to destroy the cancer) and radiation (power X-rays used to try to destroy the cancer cells).
Unfortunately, these interventions in addition to destroying cancer cells, destroy a lot of healthy cells in the process, as well as significantly diminishing the immune system of the patient, which is there to protect the body from foreign invaders, such as cancer.
Cancer cells, which do survive this trilogy onslaught, have a tendency to “come back with a vengeance”, proving immune to the technology, which initially destroyed a majority of their brethren. There is however a new technology that has been introduced to the medical community in the last decade or so; specifically, immunotherapy.
Immunotherapy refers to treatments that stimulate, enhance or suppress the body’s own immune system, such as: monoclonal antibodies, CAR T-cell therapies, immune cell inhibitors and oncolytic viruses, to name a few.
Immunotherapy works by targeting proteins or receptors on cancer cells (called antigens) to unveil them to the immune system, so the immune system can destroy them or in the case of oncolytic viruses to allow the proliferation of the virus to destroy the cancer cells, in question.
This has been proven to be a significant improvement over the trilogy of standards of care, but unfortunately, as with any new technology, it has its limitations, as the patient must have the correct antigens on their cancer cells or conversely on their immune cells to be effective.
If the patient has these antigens adequately expressed on their cancer cells, the immunotherapy technology works very effectively. If they do not, then the immunotherapy has virtually no effect.
As a result, immunotherapy is effective on only approximately 20 to 40% of the patient population treated; specifically, related to whether they have the correct antigen or not, but also due to immune resistance.
How does the Theralase® technology work and why is it an improvement on immunotherapy?
Roger DuMoulin-White: The mechanism of action of TLD-1433 (now known by the trade name RuvidarTM, where Ruthenium is the base element of the TLD-1433 compound, “vita” is Latin for “life” and “dar” is a “gift” in Russian, thus roughly translated, “Ruthenium – the gift of life”) is extremely unique.
The very characteristic that makes cancer cells so dangerous (their unbridled growth rate or proliferation) is what becomes their greatest Achilles’ heel. Due to their high proliferation rate, they have a very high demand for molecular iron (Fe) and its forms, which is used by cells for growth and development.
All cells in our body receive this molecular iron through transport via a glycoprotein known as transferrin, which is endogenous (naturally occurring in our bodies), to a transferrin receptor on all of our cells.
Because cancer cells have a very high growth rate, they have 2 to 10 times more transferrin receptors than normal cells; hence, a much greater thirst for iron. Iron is a transitional VIII or Group 8 metal, as is ruthenium, meaning that they hold 8 electrons in their valence (outer) shell.
Because of the eight electrons in the valence shell, transferrin is unable to distinguish between Iron and Ruthenium and binds tightly with either of them.
Transferrin, thus becomes the “Trojan horse” able to preferentially transport RuvidarTM to cancer cells at a rate 2 to 10 times more versus healthy cells. Cancer cells also retain the Ruthenium payload (RuvidarTM) much longer than healthy cells, so Theralase® is able to wait a predetermined time for the cancer cells to absorb RuvidarTM and then light activate it.
When RuvidarTM is light activated it produces a violent form of oxygen, known as singlet oxygen or reactive oxygen species to destroy the cancer cell from the inside out. As the cancer cells dies, its cytoplasm is released in the blood stream triggering an immune response to notify the immune system to destroy any remaining cancer cells, a process known as immunogenic cell death.
How does this technology work for patients with bladder cancer?
Roger DuMoulin-White: Bladder cancer is a disease that begins on the inside of the organ and grows into the bladder as it progresses, so the easiest access to the disease is through the urethra into the bladder.
Theralase® instructs the clinical study sites that it works on its clinical study to instill a solution of RuvidarTM into the bladder intravesically (through the urethra) and allow it to be absorbed for an hour.
The clinical study team then admits the patient to the operating room, where the patient is placed under general anesthetic. The patient’s bladder is voided and a cystoscope (metal tube used by urologists to view the bladder) is inserted through the urethra to the bladder neck.
The bladder is rinsed once with sterile water to remove any residual RuvidarTM and the bladder is filled with sterile water to remove any folds and provide shape.
A fiber optic assembly is inserted through the working channel of the cystoscope and once aligned in the center of the bladder, the TLC-3200 laser system is energized for approximately 1 to 1.5 hours (depending on the size of the bladder) to activate the RuvidarTM held by the cancer cells and destroy the bladder cancer.
The bladder is voided removing the now destroyed cancer cells and the patient is moved to the recovery room to recover from the anesthetic and the procedure. The procedure is completed in one day and due to the fact that the drug is in contact with the bladder cancer cells for only a short duration, no immunity to RuvidarTM is developed by the cancer cells, this no invincibility to the treatment.
Most patients only require one study treatment to destroy their bladder cancer, but up to two additional study treatments are allowed under the clinical protocol to destroy any residual cancer.
What are the upcoming milestones for your technology in bladder cancer?
Roger DuMoulin-White: Theralase® had completed approximately 60% of its Phase II NMIBC clinical study and hopes to enroll and provide the primary study treatment to the remaining 40 patients in 2023 and 2024.
Theralase® will need to follow these patients for a few years to assess their response and plans to submit the clinical data set for this registration clinical study in 2026 for Health Canada and the FDA’s review and hopefully final approval.
In the meantime, Theralase® is focused on obtaining Break Through Designation and hopefully Accelerated Approval and Priority Review from the FDA over the next few years. These are programs provided by the FDA that could help assist Theralase® to achieve commercial approval in the United States.
What advancements besides bladder cancer have you made in the development of this technology?
Roger DuMoulin-White: Theralase® is currently working on combining RuvidarTM with transferrin extracorporeally (outside the body) to create a new drug (called Rutherrin®) that is capable of being intravenously injected into a patient to “hunt and localize” to any cancer cells in the body.
Once absorbed by the cancer cells, Theralase® will instruct the clinical study sites to activate RuvidarTM with X-ray radiation to destroy the cancer cells of interest.
Theralase® is currently working on completing the pre-clinical work that will allow commencement of a Phase Ib/II clinical study focused on glioblastoma multiforme, a deadly form of brain cancer, in early 2024.
What advice would you have for young entrepreneurs looking to enter the medical / business world?
Roger DuMoulin-White: Throughout my career, I have found that for the various technologies that I have commercialized or are currently working to commercialize, that I did not invent any of them.
I was however lucky enough to meet the inventors of the technology and successfully negotiate the licensing or distribution rights for the technology and set about to commercialize it. This was one of my main strengths and still is today.
My advice for budding entrepreneurs is to take an honest inventory of their strengths and opportunities for improvement and to either: develop their opportunities by going to school (as I did for engineering at Western), work for other companies (as I did for production and management with Ford), learn these skills on their own through self study or via the internet (which I continue to do to this day) or to work with other individuals who possess the talents that they are lacking (which I also continue to do to this day).
In order to build your own company, you will need to cover a lot of bases and possess a significant number of strengths to be successful. Just because you good at a particular skill, does not mean you will be good at all skills required to be successful in your own business.
Ensure that you have the requisite skills or can partner with individuals who possess these skills, before you launch your venture, in order to help aid in your success.
What advice do you have for the general population today?
Roger DuMoulin-White: In my research, bladder cancer has traditionally been defined by the medical community as an older, white male disease, which is prevalent in white males over the age of 60. It is the 6th most common cancer in men and is highly linked to tobacco smoking.
The reason why is when an individual smokes a cigarette, the smoke is delivered to their lungs, where the nicotine is quickly routed via the blood stream to the satiety (satisfaction) center of their brain (hypothalamus) providing that euphoric rush; however, the remnants of that smoke; includes, over 4000 chemicals, of which more than 70 are known to cause, initiate or promote cancer.
These 70 chemicals include: hydrogen cyanide, formaldehyde, arsenic, benzene and hexavalent chromium, to name just a few and are known carcinogens. The bladder is extremely efficient at filtering contaminants from the blood and as a result these carcinogens are deposited directly into the bladder via the ureters (which connect the kidneys to the bladder) through urine.
These carcinogens over time increase the risk of bladder cancer by remaining in contact with bladder cells, damaging their DNA, and eventually morphing them into bladder cancer cells.
With the advent of vaping (electronic cigarettes), popular among the younger generation, these vapes contain many of the same carcinogens found in tobacco; however, at much lower rates.
The risk for the younger generation that smokes cigarettes or vapes to develop bladder cancer is thus a viable threat and is helping to redefine bladder cancer from a traditionally older, white male disease to a younger disease associated with all population demographics.
Therefore, the more you smoke and the longer you smoke, the higher your risk of developing cancer, especially bladder cancer. As the old adage goes, “If you don’t smoke, don’t start. If you smoke, quit.”, your health will thank you for it.
What advice do you wish you had received when you started your business journey?
Roger DuMoulin-White: I believe the advice that would have been most beneficial to me as I started my business journey, even though I wouldn’t have believed it at the time, is that it is going to take a lot longer, be a lot harder and cost a lot more money that you originally thought it would be, as along the road, there are bound to be setbacks and straight-out dead ends.
In the end, never give up on your dreams. If you truly want something, you will achieve it.
Jerome Knyszewski, VIP Contributor to ValiantCEO and the host of this interview would like to thank Roger DuMoulin-White for taking the time to do this interview and share his knowledge and experience with our readers.
If you would like to get in touch with Roger DuMoulin-White or his company, you can do it through his – Linkedin Page
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