Imagine receiving the news that you’ve been diagnosed with skin cancer. But rather than having to face the prospect of surgery or other traditional cancer treatments, the physician instead prescribes a topical skin cream that is tumor-cell selective.
That scenario may be a reality in a few short years. Faculty members conducting groundbreaking research at East Carolina University were awarded a patent in April for a metabolic product of arachidonoyl ethanolamide, or AEA, called 15deoxy, delta 12, 14 prostaglandin J2-ethanolamide, abbreviated to 15dPMJ2.The research team is led by Rukiyah Van Dross-Anderson, associate professor and Graduate Program Director of pharmacology & toxicology.
In practical terms, the researchers created a chemical compound from cannabinoids, currently a focus of study across the globe for its potential therapeutic use. Van Dross-Anderson’s team proved that a particular cannabinoid could be converted into prostaglandins, which cause cells to die. The significance of this particular prostaglandin, however, is that it only attacks cancerous cells, leaving healthy cells alone.
Allison Danell, an ECU associate professor of chemistry, worked with Van Dross-Anderson and was able to identify the molecules responsible for killing the cancer cells only, while Colin Burns, an ECU associate professor of chemistry, was able to then synthesize one of these molecules.
Being able to synthesize the molecules could pave the way for future cancer treatments beyond skin cancer as a more effective way of targeting and eliminating the harmful cells while leaving healthy cells alone. That would be a significant step up from traditional chemotherapy, which doesn’t necessarily distinguish healthy cells from cancerous ones.
“The definition of cancer is cells that are growing and dividing out of control,” said Van Dross-Anderson, who began this research in 2008. “Normally, a cell only divides under certain circumstances, when the body tells it to divide. The difference between the normal cell and the cancer cell is that the cancer cell is ignoring that. It’s dividing even when it isn’t getting a signal that it’s supposed to divide. It keeps continually dividing, which is why you get that lump, that tumor.”
While researchers are optimistic the drug, in time, could be used to treat other forms of cancer, there are still plenty of hurdles to clear: moving from animal testing to human trials; determining possible side effects and unintended consequences; and getting funding to continue research. The drug must also be approved by the Food and Drug Administration.
The team decided to create the skin cream first, because FDA approval is less stringent for topical treatments.
“Once we get the funding in place, we will be working with a pharmaceutical company in North Carolina to formulate it into a cream,” Van Dross-Anderson said. “What we are using now is pharmaceutical-grade formulation product to conduct the animal studies. We’re also doing additional tumor studies. What we’ve found so far is that our drug shrinks the tumors. The next step is to use different animal models.”
So far, the drug has shown itself to be effective against melanoma and non-melanoma cancer cells, as well as colon cancer cells, but Van Dross-Anderson thinks it will be effective against many other forms of cancer as her team research continues.
Van Dross-Anderson estimated two more years of animal studies before moving on to human trials. If everything else goes smoothly, it would likely take another five to seven years before the product actually hits the market for people to use.
She said, “We have two goals: to make sure that it’s effective, and to make sure that it’s safe. So we have to do a series of studies to accomplish those two goals.”
NC State team adds business edge to ECU’s product
Because of the enormous costs of bringing a pharmaceutical product to market, the ECU research team realized they would need some help.
Because their strengths are in the laboratory side of the equation, the ECU researchers reached out for some expertise on the business side of things.
“We needed people to focus on the business side so we can work on other things,” Danell said.
The Entrepreneurship Collaborative, or TEC, is a program at North Carolina State University that is uniquely set up to market new scientific innovations through new business startups. A diverse collective of students, both full-time and part-time, populate the Hi-TEC Entrepreneurship, Technology and Commercialization concentration graduate program, equally divided between MBA candidates from the Poole College of Management and Science, Technology, Engineering and Math (STEM) students from multiple colleges at NC State.
Steve H. Barr, a lead professor who teaches in the program, said the class receives several research technology pitches and each team ultimately selects the technology it thinks it can best turn into a company. The professors put together teams that are half-STEM, half-business.
“They bid on three technologies in a two-semester process. They first learn about technology portfolio management, and they focus and focus until they figure out which technology has the best commercial viability,” Barr said. “The cream is very interesting. It’s a medical technology and bio-science technology out of ECU. The team thought this had the most potential for becoming a high growth new business and has created a plan to commercializing it.”
The team is fully aware that even though the product has a great deal of potential, it could take years before the business built around it becomes profitable.
“Any time our teams take a product that involves a therapeutic like this, or new medical device for that matter, they are fully aware that one of the downsides is that it takes a long time to bring it to market. It’s not like opening up a storefront. It also takes hundreds of millions of dollars to make that happen. In this case, what they will likely do is create a company, help get the medical research as far along the FDA process as they can, and then, the way these things typically occur, an existing pharmaceutical company will buy the company and pick up production.”
For the individual team members – Jeff Monaghen, Rob Sucharski, Katy Salamati and Austin Richards – the length of time it might take for the cream to reach the market didn’t deter them for several reasons. One of the key aspects about the patent is that the ECU team hopes eventually to test it as a treatment for other forms of cancer through other delivery systems besides a topical cream. The market for such a drug would be potentially huge.
“We go through an ideation phase,” Monaghen said. “We try to come up with a number of different uses for the technology and see what potential products the technology can be applied toward. We then analyze to sure it’s a good fit and identify the best markets for the technology and products.”
Sucharski said the team has set up a company called Beaivi Pharma to commercialize the technology.
But beyond the business potential for the product, getting the cream to market is a personal mission for some of the team members who have been touched by cancer.
“There are over five million non-melanoma skin cancers in the US, and at least as many in the rest of the world,” said Monaghen, whose father had skin cancer.
“Each one of us has been personally affected by cancer,” Salamati added. “With this technology, we can help a lot of people. If we can get it to market, there’s a need that we can solve with this technology. Not only does it have large potential, but the mechanism of action was very intriguing to each one of us. We considered 30 technologies, but this is the one we chose to develop.”
Richards had a bout with pre- cancer previously, Monaghen’s father had skin cancer, while Sucharski developed non-melanoma cancer once, which recurred five years later.
“I’ve gone through the various treatments for non-melanoma,” Sucharski said. “Surgery is not always effective. I’ve had to have two different types of surgery and it’s been five additional years, and it’s been so far, so good. Then, during the class, I had pre-cancer develop. So, I have personal experience with these issues.”
“We’ve talked to dermatologists and pharmacists, and we realized that there really is a need for the cream which could be very successful,” Salamati said.
Monaghen said the enthusiasm displayed by the ECU research team was another reason the business team wanted to market the product.
Danell said the research team is applying for grants to help continue their laboratory work, but that the business team also was also helping to bring in funding by applying for grants and looking for opportunities through venture capital groups. Salamati said Beaivi was there to “build a roadmap to avenues for bringing in funding and bringing in investments in the company.”
With proximity to Research Triangle Park and the number of pharmaceutical development companies in North Carolina, Beaivi feels confident in finding willing investors for the company. Barr said one of the greatest benefits of the Triangle area is the number of experienced executives seeking new products, giving the students real-world mentors with both the business experience and connections to launch a new product successfully.
“It’s exciting because it touches lots of potential markets,” he said. “It’s a high-risk, high-reward product.”
Van Dross said she’s been amazed to see how far the project has progress over the years.
“We started out as a really, really small project,” she said. “I’ve slowly added people to the group that bring in their own expertise. At this point, we have a really comprehensive group of people.”
Written by Phillip Ramati