January 27, 2014 Issue
The Most Powerful Name In Corporate News and Information
Clinical Stage Mitochondrial Medicines
About OgenX Therapeutics
Corporation is a clinical stage mitochondrial medicines company. The Company
is advancing a highly proprietary platform of 35 compounds called Redoxagens,
developed for the treatment of numerous high-value disease targets. OgenX
operates in three areas of activity: Animal Health, Human Health and
Biodefense. The Redoxagens affect the most primal level of cellular
activity. They are designed to upregulate redox-mediated DNA signaling of
those genes that are responsible for turning on innate cell self-repair
mechanisms. Our two lead compounds have been tested in over 300 humans and
over 8,000 animals among fifty diverse diseases with profound success and
without evidence of any significant adverse effects. Our principal focus is
directed toward our veterinary business,
Ogenx Animal Health
treatment of Canine Lymphoma and Canine Mast Cell Tumors. We are
accelerating toward commercialization under MUMS designation regulations
that afford us the potential to launch our lead candidate, RC-2 Beta within
the next 12 to 15 months. We intend to leverage the revenues from those
product sales to expand our indication in animals, while simultaneously
moving to finalize our IND-enabling studies directed toward a number of
human disease targets - beginning with a novel treatment for the tens of
millions of patients with the Dry form of Age-related Macular Degeneration.
In 1977 Dr. Davis
graduated magna cum laude with a BSc. in Chemistry from Old Dominion
University. In 1981, he received his M.D. with honors from the Medical
College of Virginia.From 1982-1986 he rose to the rank of Lt. Commander
Officer in the United States Navy while serving as a Naval Flight Surgeon
(backup flight surgeon for the Blue Angels) and Hyperbaric Officer (and SEAL
Team physician).During his service he received two meritorious citations
from the Chief of Naval Operations for his outstanding individual
contributions to the Medical Department of the Navy.
PO Box 88
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – January 27, 2014
CEOCFO: Dr. Davis, what is the concept for OgenX Therapeutics?
Dr. Davis: OgenX is blessed with a highly experienced team of seasoned biotech professionals. Our experience allows us to maintain a very aggressive program that is pioneering a new therapeutic class of biomimetic cytochromes based upon proprietary discoveries in redox-mediated mitochondrial DNA signaling of cellular self-repair mechanisms. Our synthesis method is new; the drugs are new; the mechanism of action is new – virtually everything that we are doing has never been done before. We are in uncharted waters in many respects, but our results speak for themselves. It is all very exciting.
CEOCFO: What is the science?
Dr. Davis: OgenX is built upon the findings of thousands of peer-reviewed papers that suggest that most chronic diseases like cancer, autoimmune diseases, neurodegenerative diseases and diseases of inflammation are in some way caused by, or promoted by, the inability of cells to efficiently metabolize oxygen into energy. This physiologic breakdown is commonly known as “oxidative stress.”Over the past 25 years scientists around the world have begun to identify many of the complex, dual signaling roles of pro-oxidant/antioxidant that are evident in compounds like Vitamin C and similar naturally-occurring molecules that combat oxidative stress. Like many researchers today, our team believes that the solutions to most major diseases will entail enhancing the core mechanisms involved with how cells process oxygen in our bodies to generate sufficient energy (bioenergetics) to turn on innate self-repair systems in stressed (diseased) cells. One third of all research dollars today are chasing this thesis. Our research has focused on compounds that limit free radical formation now widely recognized as a contributing cause of most chronic diseases. We have developed a group of redox-modifiers, called Redoxagens, which have demonstrated an uncanny ability to interrupt and then promote a reversal of the damage caused by these free radicals in oxidatively stressed cells.“Restoration” is a fundamentally basic mechanism that is postulated to lie at the core of cell physiology in all living things. Therefore, according to this theory, if there were a way to turn on these self-repair signals, one would expect to see therapeutic responses in a number of diseases that have been heretofore believed to be unrelated. Furthermore, if this hypothesis is correct, you would expect similar results to occur across multiple species. In point of fact, our groundbreaking research with the Redoxagens is consistently demonstrating these predicted results. We are observing therapeutic responses in many diseases that have resisted conventional therapies.
CEOCFO: What exactly is going to happen when you develop the platform? What will be happening in the body that does not happen now?
Dr. Davis: That is a great question. Again, on a theoretical basis, if there were a way to successfully upregulate cellular bioenergetics one would expect to see many positive adaptive downstream effects, and would not expect to see much, if any, reactive negative effects. Our research is bearing this out. We are consistently observing the Redoxagens’ ability to restore the needed energy balance that enables cells to do what they are fundamentally designed to do in nature; which is to undergo “self-repair.”You see, all nucleated cells, when placed under stress, can only respond in four ways - they can initiate self-repair; they can divide; they can go to sleep in a process we call ‘senescence,’ or they can commit suicide in a process we call ‘apoptosis. ’Self-repair is always the cell’s first choice, but this is a complex process which requires a big burst of readily available energy. What is really interesting is that the studies that we have conducted to date demonstrate that the self-repair pathways that the Redoxagens promote are agnostic with respect to the specific cause of the stress itself. It just does not seem to matter whether it’s a cancerous process, a viral infection or another agent – when we treat stressed cells they all respond similarly to initiate self-repair. This has potentially major implications as you can imagine.
CEOCFO: You have an extensive background with many, many companies and many, many patents. Why did you think that this was the way to go and that oxygen and the way it works in the body is the key?
Dr. Davis: As a matter of fact, I did not believe in this technology when it was initially introduced to me. I was a tremendous skeptic. It was simply too good to be true. I spent over a year reviewing all of the original data then conducted my own personal due diligence and spoke with the cadre of researchers around the country that had been involved in the early development and testing of the technology before I became a believer. My biggest problem along the way was not the technology – it was me. My preconditioned notions about what was possible really got in my way. As I said before, the Redoxagens just seemed too good to be true. The results were so far beyond my experience I simply refused to accept what I was learning. I mean for something to work so simply, so safely and so effectively against so many different diseases in so many animal species, including man – was just outrageous. I am classically trained in the traditional sciences, and there is nothing traditional about the Redoxagens. So the problem was with me – not the technology. I guess what really won me over was the repeatability of the data from some of the nation’s best researchers that were consistently reporting the same results. At some point I just could not ignore it anymore and I said “OK, I give.”What made my decision even more difficult was that my wife and I had just retired to our beachfront home in Florida. Our lifestyle was envious, cycling, kayaking, playing golf and generally having a ball. When I was approached to take over the reins of the company, I knew what would lie ahead. Taking on a world of skepticism is never easy. But I have to say that I have not been disappointed. All of the data that we continue to gather is remarkable, just remarkable. The amount of good that may be possible is beyond imagination.
CEOCFO: Where are you in the process?
Dr. Davis: We have a lot going on right now. My team, led by my Chief Regulatory Officer – Dr. Peter Urrea, has worked very hard to clear a direct path through all of our regulatory hurdles. Over the last year, we have received FDA waivers that have saved us nearly $1.8 million dollars in filing fees; we have received 2 MUMS designations; we have had all of our protocols approved; we won 2 competitive grants from the FDA which were also peer reviewed by experts at the NIH and a panel of academic and industry experts. We have just initiated pilot enrollment for the final set of clinical studies in our animal health business that are designed to lead to our first FDA approval (in 2 cancer applications in dogs); which could happen within the next year assuming all goes well. Dr. Heather Wilson-Robles is our principal investigator for these two trials. She runs the canine oncology service at Texas A&M University, which is widely recognized as one of the best programs of its kind in the country, if not the world. My secret is to only work with the very best people and she is an absolutely amazing individual. In parallel to all of this activity, Jim Smith - my Chief Business Officer, and David Boyle, my CFO are currently leading our efforts to raise our first significant round of funding as well as decide among a number of other financing opportunities. OgenX has come an awfully long way on a shoestring budget. But you can only bootstrap a company for so long. At some point you need to reach out to deep pocket investors to accelerate a Company’s evolution. Finally, my Chief Science Officer, Dr. Dmytro Berezhnoy is leading our Biodefense group in collaboration with the US Army’s bio weapons research team in Fort Detrick, MD. They have been investigating some of the Redoxagens’ effects against a wide variety of some of the most devastating viral diseases in the world, like Ebola and others. They have seen some very promising results thus far. Needless to say we are very excited and have a lot of reasons to be optimistic about our future role in this area of intense national security.
CEOCFO: Why start with canine products?
Dr. Davis: The biggest problem that our team had to face at the beginning was – with such a broad pallet of choices, where do we start? The Redoxagens had developed an extensive pedigree of pre-clinical experience with animals - especially horses and dogs, so that seemed a natural place to begin. We worked closely with the animal health group at FDA to determine the greatest need and applied for and received special designations called MUMS, (Minor Use Minor Species) for two canine cancers. MUMS is a specific regulatory pathway that allows a company to get to market quickly through an accelerated program. The MUMS regulations in animals are promulgated by the Centers for Veterinary Medicine at FDA. They are similar to a combination of ‘orphan drug’ and ‘compassionateuse’ regulations overseen by CDER (Center for Drug Evaluation and Research); which is the side of the FDA that deals with human drugs. We are only the third company in history to receive both MUMS designations for these 2 dog cancers. The costs under MUMS are significantly less than a similar effort that would result in commercialization in humans. Our plan is to enter the $56 billion dollar animal health market first, then, once established there, we will petition for a translational path to bring the drugs approved in the animal health side, and introduce them into applications in human disease; for which we have a very high degree of confidence for success based on prior experience.
CEOCFO: Both personally and for the company, when you have something that is so promising and could do so much good and it is so difficult to go from concept and proof to utilization; how do you handle the frustration?
Dr. Davis: I think you have to have a thick skin and a lot of optimism. My team and I are very experienced. We have over 200 years of industry experience and 30 advanced degrees among us. All of us are cautious by nature, but the data just keeps coming back better that we expected. That has a way of making each of us increasingly optimistic. I think you also have to be a realist in this business and recognize that whenever you have something that is this new that many people will be skeptical, just like all of us were skeptical in the beginning. You have to be prepared go along time in a very dark and lonely tunnel while you work very hard to provide the level of proof that is required to gain the necessary level of acceptance. After all, the Redoxagens are like any game-changing technology that poses a significant threat to the status quo. In order to fulfill the technology’s potential you have to be able to gain the acceptance and trust of the first adopters; both within the scientific community, the financial community, the medical community and with the public at large. The rest will take of itself if you are compulsive about taking things in their proper order and not getting ahead of yourself. I think that this responsibility is our greatest challenge. We must always be conscious to provide the necessary level of proof then communicate that proof to the different audiences that make up our target marketplace. At the end of the day, you hopefully come out with a package of information that people can digest and become comfortable with. This is no small feat for anything that is so new and as potentially revolutionary as the Redoxagen technology. This would be the expected case for anything that has never been seen before. But my team is up to the challenge. We have worked for stock without pay for two years to generate data, the likes of which has never been seen before. In an odd way, that makes it even tougher. When you have something that is so new and it is having these kinds of amazing results, people’s initial response will predictably be just like mine; ‘it is simply too good to be true.’ To overcome this reaction, you really have to go out of your way to reveal the data in an organized stepwise fashion so that each step can be evaluated and discussed. This way people will have time to get reeducated to the possibilities of what this kind of breakthrough can mean to animals and humans alike. It is a very difficult path, but one that we are absolutely committed to follow, no matter how tortuous. The Redoxagens are the single most important discovery that I have ever witnessed. That’s certainly worth the trouble.
CEOCFO: Does the veterinary community embrace newer ideas, newer technologies and new drugs faster than the human medical community or are you facing the same challenges as with your first product?
Dr. Davis: In some ways, I think that the veterinary community is more open to new ideas. That is because vets are not hamstrung by many of the insurance, governmental, malpractice and medico-legal issues that physicians face. Therefore, they have a runway that is maybe a little wider and a little longer for them to be able accept new ideas and try new things. Also, they are avid pet lovers. I have never met a vet that does not absolutely adore their patients. They would go to the ends of the earth to save them. Therefore, they tend to be more willing to try new ideas, as long as they have sufficient evidence that a new treatment is safe and potentially effective. This is not to say that they are reckless or cavalier. Each vet has their own individual threshold of required proof before they will try something new. However, I think that the bar is a little bit lower for vets than it is for the majority of physicians. With that being said, there is an eagerness and a palpable excitement within the veterinary community about the potential of the Redoxagens. OgenX is privileged to have seven veterinary scientists on our advisory board that are widely recognized as some of the most influential opinion leaders in the business. They were not easy to recruit. Each one conducted a significant amount of due diligence before they agreed to join the company. All of them are very excited to see the progress that we have made and witness, first hand, some of the astounding results that we have obtained.
CEOCFO: How will you be reaching vets when the product is ready for sale or usage?
Dr. Davis: The first applications for our lead candidate, RC-2 Beta, are two cancers that occur commonly in dogs; Canine Lymphoma and Canine Mast Cell Tumors. The US market consists of 249 veterinary oncologists. They are supported by approximately 1,200 ancillary clinics. This is a very addressable market, where everyone knows one another either directly or by reputation. Therefore, we intend to retain a small, highly focused domestic sales force to penetrate this audience. In addition, we will provide regular follow up at conferences, symposia and through a stream of on-line journal articles to update everyone with the latest information as our clinical experience grows and our science matures. We will be totally transparent with our results. That will be the best way to engender trust and quickly build a solid reputation. We only work with the very best people, the very best scientists and to do the very best clinical work that can be done. There are no shortcuts to performing good science. The world is moving too fast. You have to do it right the first time, or you won’t get a second chance.
CEOCFO: Why doesOgenX Therapeutics standout?
First of all, nothing
like the Redoxagens has ever been studied before. The data that we have
generated has never been seen before. We have developed a very close working
relationship with the FDA. The team at CVM has been really great to work
with. They have been direct and responsive. None of our closest competitors
have obtained MUMS fast track designations, and none are positioned to
commercialize their initial product in about a year like we are. Our costs
are only about five percent of what it would take to bring a human drug to
market in the same situation. Therefore, from a value stand point, from a
timeline stand point, and from an impact stand point; our opportunity is
unparalleled in my experience. From an investor’s standpoint, the return on
investment could be as big as one could imagine. From a clinician’s
standpoint, the opportunity to provide new solutions to huge problems has
never been more promising. From a patient’s stand point there is now hope
where there has not been hope before. This confluence of interests from
these three constituencies makes OgenX uniquely special. Finally, the
promise offered by the Redoxagens is almost like talking about penicillin or
prednisone when they were first discovered. Our science has applications
that are so disruptive, that we have the potential to make a dramatic impact
on healthcare on a global basis. That is the way that people need to look at
OgenX. Of course, that is a huge statement and we will need to put our money
where our mouth is and prove it. But that is what we are up to every day.
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