UPDATE: New data strongly support further development of C3 as a promising therapeutic agent for Parkinson disease.
Why is your company called The Bronx Project?
When TBP CEO and founder Ed Handler was a child, his father had just volunteered for World War II, so he moved his family from New Jersey to a newly opened housing project in the East Bronx that was financed and owned by Metropolitan Life. It was called Parkchester, and he remained there with his family until war’s end when they then went off to Germany to join his father, who was a part of the Allied Occupation.
During their stay (and beyond) in Parkchester (resumed two years later) Ed’s mother's best friend was Pearl Seelig, whose son Stephen, two years his junior, became his best friend. Steve went to Bronx Science High School and graduated at 15, then went off to RPI for an electrical engineering degree, service as a lieutenant(with jump wings) in the US Army Ordnance Corps, Cornell Law School law reviewer , a judicial clerkship and then a fine record as a preeminent Connecticut trial lawyer. In his mid-forties, Steve Seelig was struck with ALS (Lou Gehrig's disease) and fought valiantly for 5 1/2 years until his death. Ed saw his friend frequently during this period and wondered if somehow there was an answer to this disease, for which there is still no cure. When C3 and Dr. Laura Dugan’s work came to his attention, he decided to name the company after a housing project in the Bronx as a fitting tribute to his old brave friend Steve Seelig. Ergo, "The Bronx Project, Inc." Not only was Ed affected by Steve’s death; a number of the company’s early investors are also Parkchesterites who knew and grew up with Steve.
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What is Dr. Dugan’s work about?
Dr. Dugan’s work relates to the use of fullerene-based compounds to treat, ameliorate and restore central nervous system (CNS) function to sufferers of a variety of CNS diseases -- including but not limited to Parkinson's Disease, Alzheimer's Disease, Schizophrenia, Multiple Sclerosis and Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's Disease. This commercialization process will involve further pre-clinical long-term toxicity studies, followed by the staging of FDA-approved clinical trials, followed by manufacture and sales of the compound as a commercially approved treatment for these diseases. To date, Dr. Dugan's work has shown great promise in ameliorating the effects of these CNS diseases in both laboratory mice and rats, with non-human primate (NHP) studies ongoing. Her work has been effective in halting disease progress, protecting neuronal components and restoring motor function, cognition and memory in several disease models.
View a selection of papers relating to Dr. Dugan's work in CNS and C3 by clicking here.
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Is there patent protection on Dr. Dugan's work?
While strong research is the foundation of science, pharmaceutical companies depend upon strong patent portfolios to protect their investments in new compounds. Dr. Dugan has been patenting new developments continually as her research has progressed and her discoveries are protected, at a minimum, at least through 2022. As new developments in her research bear fruit, that protection will be extended.
View a list of Dr. Dugan's patents by clicking here.
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Why Central Nervous System diseases?
The number of CNS patients is increasing, due to aging, environmental causes, injury, genetic factors and other causes not yet fully understood. As a result, the number of CNS sufferers, now estimated by the World Health Organization to potentially be as high as 140 million worldwide, is expected to grow at a compound rate exceeding 10 percent annually for the foreseeable future.
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Why are CNS diseases on the increase?
As the world continues to move toward increased urbanization, improved education and a higher pressure, more stressed set of lifestyles, the rise of living standards appears to be accompanied by increases in CNS diseases. At the same time, as living standards around the world continue to improve, there is a greater demand for better health care, so that CNS diseases that might have previously gone undiagnosed and untreated are now being diagnosed and attempts made to treat them. In addition, per capita spending on health care in many newly emerging nations, such as Brazil, Turkey, Russia and Chile, is beginning to inch closer to developed world levels. There is also a shift in many nations away from bacterial-based diseases, which can be treated via antibiotics, to what might be termed "lifestyle” or stress-related diseases, such as diabetes, heart disease, hypertension and the CNS diseases.
While these trends are developing, national populations are also aging. With the exception of a number of nations where large families and high birth rates are still the norm, there has been a general move to limit population growth in many nations, either formally -- as in the case of China' s one child policy -- or informally, with change brought on by economic pressure and an increase in working women. As a result, the population curve is shifting towards the right, with an increasing number of older people per thousand population and fewer young people. With aging comes a rise in CNS diseases, which are thought to be at least partly the result of cellular deterioration. In 2008, there were about 605 million people over 65 in the world. According to population studies by the United Nations, by 2050, that number is expected to reach 2 billion. It is likely that an increasing number of them will come down with CNS diseases.
Environmental factors are also likely to be contributing. There are still no direct links between CNS diseases and environmental factors such as air and water pollution, but there are many studies that suggest a linkage, especially between ozone and a rise in what are called reactive oxygen species (ROS) levels in both plants and animals. ROS levels are believed to become abnormally increased in tissues outside the nervous system as well, so it may become necessary to develop therapies that can be applied to a wider patient population than those with CNS diseases, alone.
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How does Dr. Dugan’s work affect these problems?
The five major CNS diseases exact three distinct tolls on society: Treatment costs are large and rising -- $250 billion in the U.S. alone in 2006. Productivity losses are high -- an estimated $500 billion a year in the U.S. from work that cannot be performed by CNS patients. Beyond that, there are the costs to morale and spirit to both patients and their families. This high cost is rising, and it is unacceptable both to individuals and society.
Dr. Dugan’s work begins with a conundrum – that while there are many drugs on the market that are being used to treat CNS diseases, there are still few drugs – for example, L-dopa for Parkinson’s, which works well for a while -- that are all that effective as treatments. Nearly all of the drugs available are either limited in effectiveness or do not really work at all (placebo effect), have unpleasant side effects or can produce their own immune responses, which greatly limit or impair what little effectiveness most drugs have.
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Tell us something about Dr. Dugan.
Dr. Laura Dugan has a long history of research into the causes and treatment of central nervous system diseases and the causes of aging. She is an Associate Professor of Medicine, and is the inaugural holder of the Larry L. Hillblom Chair in Geriatric Medicine at the University of California, San Diego (UCSD). She holds joint appointments in UCSD’s Departments of Medicine and Neurosciences, and is board certified in both internal medicine and geriatrics. She received her SB in Life Sciences from the Massachusetts Institute of Technology, and her M.D. from the Ohio State University College of Medicine. She completed residency training in Internal Medicine at the UC San Francisco Children’s Hospital of San Francisco, and served as Chief Resident in Medicine her final year. She was a United States Presidential Scholar as an undergraduate and has been the recipient of a Dana Research Fellowship, a Paul Beeson Physician Scholars Award through the American Federation for Aging Research, a Hartford Foundation Award for Geriatric Research, a Hartford Leadership Scholars in Geriatric Medicine Award, the Kopolow Award for Geriatric Psychiatry and Neurology, and an Innovation Award from the St. Louis Academy of Sciences. Dr. Dugan's research focuses on the basic biology of nervous system aging and the role of free radical neurobiology in aging and neurodegenerative diseases. A component of recent work has focused on rationally-designed buckminsterfullerene derivatives as antioxidants and neuro-protective agents. Dr. Dugan is a key scientific consultant and advisor to The Bronx Project.
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What are Buckminsterfullerenes?
This new form of elemental carbon was made of groups of sixty or seventy atoms all linked together to form what looks like tiny soccer balls. In fact, if you look at a soccer ball, you will see that its round shape is actually a combination of hexagons -- six-sided shapes -- and pentagons -- five-sided shapes -- that is identical to this new form of carbon. The scientists who discovered it thought that it resembled the geodesic dome structures designed by Richard Buckminster Fuller, the visionary architect and industrial designer, so they called their new form of carbon buckminsterfullerene. This compound and related ones are now also known as fullerenes, to describe a class of compounds that can be as few as 20 carbon atoms in ball shape, or which can form in tubes or lattices that are also called nanotubes. The ball-shaped fullerenes are also known as buckyballs. The group of scientists who discovered the compounds won the Nobel Prize in chemistry for their discovery in 1996.
Buckminsterfullerenes are a class of carbon whose existence was unknown, although theorized, until 1985. In that year astrophysicists from Sussex University in England and Rice University in Texas who were attempting to duplicate the effects of the death of a giant red star in the lab turned a laser on a mixture of nitrogen, helium, hydrogen, oxygen and carbon bar stock -- the basic molecules found in stars -- inside a bell jar. When the laser was turned off, what was left was water and a reddish brown substance. That substance turned out to be a form of carbon never before seen in nature. Normally, carbon exists in nature in three forms: a crystalline form, where atoms are tightly packed in a rigid cubical structure that we call diamonds; a looser lattice structure where the carbon forms in sheets, that we call graphite; and a non-structured form commonly called soot.
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Tell us about Dr. Dugan’s Compound.
The Bronx Project's translational effort to bring Dr. Dugan's research work from laboratory to commercial use is related to a compound known as C3. C3 is a rationally designed buckminsterfullerene derivative of about 1 nanometer in diameter that can be used as a catalytic antioxidant and as a neuroprotective agent. It is many times more powerful than the most active natural antioxidants, such as Vitamin C or Vitamin E. Indeed, while eating fruits and vegetables high in antioxidants promotes heath, it is nearly impossible to consume enough natural anti-oxidants to remove ROS, specifically superoxide in disease conditions, despite the claims made by those who advocate the use of natural supplements and diet.
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What is the role of antioxidants in maintaining health?
The relationship between the high antioxidant capacity of fruits and vegetables and the positive impact of diets high in fruits and vegetables is believed to play an important role in the free-radical theory of aging. It has been known for some time that antioxidants can help boost the body's own defenses against a variety of diseases, by assisting the body’s own defenses against superoxides.
Inside each cell, there are two proteins specifically designed to neutralize excess superoxides. These are formed in normal cell metabolism. One is catalase and the other is superoxide dismutase (SOD). Both have the job of breaking down superoxides, which are highly reactive oxygen molecules, such as O3, O5, O7, and hydrogen peroxide, H2O2, that have an affinity for grabbing on to fatty tissue in the body and destroying it.
In a healthy person, the body's own production of SOD and catalase are sufficient to keep superoxides under control. But over time, and with prolonged stress to the body -- by stress we mean environmental damage (excess sunlight, exposure to pollution or hazardous chemicals), certain emotional stresses, or just the plain fact of aging, which over time can cause transcription errors in the manufacture of DNA -- the body can lose its ability to produce enough catalase or SOD to keep excess superoxides at bay. A diet rich in antioxidants can therefore help keep a healthy person healthy, but it cannot do much once cells stop producing catalase and SOD.
This is a very important point because when the body produces excess superoxides or sometimes, hydrogen peroxide, both of which are destructive to nervous tissue especially, any antioxidant that you take in, such as Vitamin E or red wine or pomegranate juice, to take three examples, works on a one for one basis against the excess oxygen. That is, one molecule of the antioxidant neutralizes one molecule of excess superoxide. If you are a healthy person, such antioxidants can't hurt, and probably give the body a tiny extra antioxidant boost. But for conventional antioxidants to replace lost cellular superoxide dismutase or catalase, you would need to consume vast quantities of them – for example, one hundred gallons of pomegranate juice per day to equal the antioxidant capabilities of the cells of your own body.
TBP’s compound, C3, does not perform like any conventional antioxidant. It does not perform a one to one exchange. C3 is a catalyst, and if you remember your high school chemistry, a catalyst works by facilitating a chemical reaction without being part of it, and without changing its own composition. C3 acts to dismutate -- which means break apart -- excess superoxide by electrochemically drawing a superoxide molecule to its surface, and at the same time drawing hydrogen molecules that exist in every cell, and facilitating their combination into water and chemically stable O2. The water is flushed from the body with urine, and the O2 is either used by the cells, or recombines with excess carbon, via a different cellular process, as CO2, which you breathe out through your lungs.
How powerful is C3 as an antioxidant? Remember: It would take 100 gallons of pomegranate juice per day to perform the work that your cells normally do to get rid of excess superoxides. A pill of C3 of 45 milligrams – about half the size of a baby aspirin -- is sufficient to do the work of 100 gallons of pomegranate juice.
Because C3 is a catalyst, and does not take part in the chemical reaction, there are no by-products of the reaction. In a wide variety of animal tests to date, there have been no observable side effects of the type that are common with most other drugs, because the body does not have to find a way to shed the by-products of a reaction. There is also no toxicity, because there is no chemical activity of the C3. It enters the body, facilitates the change of superoxides into stable molecular oxygen and water, and is then flushed from the body by the body's own normal cycles, in about eight hours. A single 45 mg dose provides enough protection to the body to last all day.
Why is this important to people who suffer from central nervous system diseases, such as Parkinson's, schizophrenia, Alzheimer's, ALS or MS? Nervous tissue -- the nerves, the myelin sheath around them and even the brain – are between 60% and 85% fatty tissue. Since superoxides attach to and destroy fatty tissue, particularly the type of fatty tissue found in nerves, keeping superoxides under control can halt the progress of central nervous system diseases. Dr. Dugan has performed over 15 years of experiments with C3 and has found that it works on all of the central nervous system diseases in exactly the same fashion, at the same dosing level. With such success in animal models -- in mice, rats, piglets and non-human primates (monkeys) -- there is a substantial probability that the compound -- not a drug because it is non-metabolic -- will work similarly in humans.
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What about toxicity? I’ve heard that fullerenes are dangerous.
Prior to FDA Phase I clinical testing, which is used to establish non-toxicity and activity, there are already strong indications of non-toxicity of the compound. In mouse studies, the fullerene compound C3 has been radio-isotope tagged prior to administration, so that when it is administered and upon autopsy, its accumulation could be measured. In those tests, there was no accumulation of the compound in the test animals. In addition, autopsy studies show no damage to organs, and no accumulation of the compound in the body. As lab work progresses, TBP's goal is to fully develop a family of products, all based upon the ideas contained above:
A. That the compound will be effective as a catalyst in converting ROS and superoxides into water and flushing that water from the body;
B. That the drug will have few if any side effects;
C. That the drug will be fully excreted from the body;
D. And that the drug will be available to treat a wide range of diseases, beginning with ALS and extending to other CNS conditions.
In the early days of fullerene research, there were papers published suggesting that the fullerene C60 might cause chromosonal or genetic damage. That early research has been widely refuted. Further, just as benzene is a chemical that can be harmful to humans, when it is chemically changed by the addition of other molecules, it becomes the foundation for entire families of beneficial drugs. C3 is not C60, and has to date shown none of the damage originally suggested in early C60 research.
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Besides lack of toxicity, what other advantages does C3 possess over other CNS treatments?
Dr. Dugan commenced her work in fullerenes at Washington University in St.Louis in 1993 and filed her first patent for the use of fullerenes in a medical setting in 1994. Since then she and her colleagues have pushed their work forward to prove the effectiveness of fullerene-based compounds in the treatment of CNS diseases in animal studies, publishing and patenting as they have gone along.
Aside from non-toxicity, fullerenes have the ability to add other molecules to them without changing the physical structure of the fullerene. This property has been exploited by Dr. Dugan in designing the compound, C3, which adds three carboxyl groups – malonic acid – to the fullerene ball.
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Then is C3 a potential miracle cure?
C3 is technically not a cure at all, but rather, it is an ongoing therapeutic treatment designed to prevent further damage or deterioration of tissue. It also seems to correct some damage insofar as memory function is concerned. Based upon what Dr. Dugan has so far discovered in her pre-clinical treatment of several important CNS diseases, it is possible that similar results could be achieved in humans with Parkinson’s Alzheimer's, Schizophrenia, MS and ALS in the near future.
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When will C3 be on the market?
It is the intent of TBP to bring Dr. Dugan's compound to a commercial level. TBP intends to take the company, at the very least, through an FDA-approved Phase I Clinical Trial. While compounds that appear to be effective in animal studies often fail to make it through to full commercial development, it is the belief of TBP and Dr. Dugan that, based upon extensive studies employing both rodents and primates, the compound under development exhibits no toxicity, and improves CNS function in animals that exhibit CNS disease symptoms.
If such clinical trials bear out, TBP intends to either manufacture the compound itself, depending upon the development of the company's capabilities, or to create a partnership arrangement with a major pharmaceutical company for manufacture and distribution.
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Besides Dr. Dugan, who else is involved with the Bronx Project?
In addition to Dr. Dugan, Richard Pellegrino, M.D., Ph.D. is The Bronx Project’s Chief Scientist. Dr. Pellegrino is a former National Multiple Sclerosis Society fellow, Trustee of the American Academy of Pharmaceutical Physicians, and winner of the Ten Outstanding Young Americans award for 1995. He is a practicing neurologist and researcher in Hot Springs, Ark., with a special interest in Multiple Sclerosis.
Edward J. Handler, III is the Chairman/CEO of The Bronx Project. He is a former senior partner and of counsel, Kenyon & Kenyon, LLP (40 years). He holds a J.D., University of Virginia. Law School; B.S., USMA (West Point). He is admitted to the bar in New York, the United States Supreme Court, U.S. Court of Appeals for the Federal Circuit. He has been named among the World's Leading Patent Lawyers, 2003, by Euromoney; World's Leading Trademark Lawyers, 2004, by Euromoney. U.S. Patent and Trademark Office Bar Member.
Stephen Kindel is the President/Chief Operating Officer of The Bronx Project. He has worked in global wealth management at Citibank and other firms and has worked on the startup of numerous firms, several of which have become highly successful public companies. He holds a B.A. from Hofstra University and completed course work on an M.A. in Strategic Intelligence from the University of South Carolina. He is the author of numerous books on finance and executive leadership, and has also worked in journalism and marketing.
Joseph E. Root is The Bronx Project�s General Counsel. He is an attorney with 30 years experience developing, protecting, and exploiting patent portfolios. He serves as Chief Patent Counsel to UnitedLex Corp. a leader in legal process facilitation, with operations in the US and India, and he is the founder of QualiPat, LLC, where he provides improved patent drafting and technical writing training. He is the author of �Rules of Patent Drafting: Guidelines from Federal Circuit Case Law�, published by Oxford University Press in 2011. Previously, he served as General Counsel to both public and private technology companies. He engaged in private practice with the New York office of Kenyon & Kenyon. Mr. Root received a J.D., magna cum laude, from Wake Forest University, and a B.S. from the United States Military Academy, West Point, NY. Before attending law school, Mr. Root held engineering and production management positions with Corning and General Electric.
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Where can I learn more?
Please return to this site periodically. As we have more information, we will post it.
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