How Smart is Your Mouthwash?
This dentist-inventor devised a process that spawned two products that launched a company that just might bring to market the next big thing for your mouth’s well-being.
Necessity is the mother of invention — or so they say. So, what inspired Daniel Fine, DMD, to become an inventor, an entrepreneur, and the founder of a new New Jersey company called Affineti Biologics? An inventive mind — certainly, a determined spirit — surely, research acumen — without a doubt, and, necessity, of course.
“Basic research has traditionally been supported by grants from the National Institutes of Health and the National Science Foundation. Those funds are hard to get now,” the researcher explains. And Fine, professor and founding chair of the highly regarded NJDS Department of Oral Biology (seventh in the country in federal research funding), was at the point of translating his long-term research into “clinically useful products.” Funding to underwrite the future of his promising research would be pivotal in propelling his new, small business forward.
Fine’s decades-long research into the pathways of particularly damaging oral bacteria, called Aggregatibacter actinomycetemcomitans or Aa, has rewarded him with insights about the affinity that certain bacteria have to mucosal tissue and how they cling to that tissue to cause disease. So, looking at the flipside, he set out to understand how to break that “magnetic attraction” and detach the bacteria from their natural target. And he did just that.
“We created a decoy molecule to compete with the infectious agent and prevent it from attaching to either the tooth enamel or its mucosal surfaces,” the researcher states.
By fusing parts of two salivary proteins — one from lactoferrin, which functions as an antimicrobial, and one from statherin, a salivary protein with a natural affinity to enamel — he was able to synthesize a “sticky” peptide that attaches to enamel surfaces and blocks plaque formation. The truly ingenious aspect of this newly created fusion peptide is that it is released slowly from that enamel surface. In other words, when its work is done, it goes away.
“Half of this peptide is an active-antimicrobial with the ability to kill a wide variety of bacteria that cause caries and gingivitis; the other half works to make the bacteria-killer stick to its target,” he explains. In other words, the new peptide does the job of an antibiotic, but it homes in on the problem area, is not harmful or toxic to human cells, and does not travel systemically.
Fine, who in the mid 1980s discovered the mechanism of action of Listerine and how it interferes with periodontal disease, says his product is designed to have a similar outcome but will not need to be supplemented with alcohol. Since initial clinical trials have demonstrated that Fine’s product is effective against plaque, and since it’s also a naturally derived product (made from the body’s own elements), larger clinical trials may begin within months.
Fine is also working on an antidote to dry mouth using the same peptide-fusion process, but with different peptides. “There is nothing on the market currently for dry mouth except for Biotene, which has a minimal and limited effect, and chewing gum, which has its own limitations,” he says. “Dry mouth is a quality of life issue, not a disease. But it affects a lot of people.”
“You would use the rinse for dry mouth just twice a day,” says the inventor. “It’s convenient, nontoxic and it works.” Built on the same basic premise as his new antimicrobial mouthwash, the dry mouth rinse is composed by fusing two small peptides — one peptide from a common bacteria that attaches to epithelial cells and a second peptide that absorbs water. The product lubricates the mouth, but it also sticks to mucosal surfaces, so the effect is lasting.
“You first rinse with this new product and then rinse your mouth with water,” he explains. The lubrication is sustained for six to twelve hours. “Our goal is that you could rinse just once in the morning and then once at night and the effect would last around the clock.”
The first product binds to hard tissue (enamel) and the second binds to soft tissue. “But the premise is exactly the same,” states Fine.
Future research in his lab will address how this same process could be applied to nasal and corneal surfaces. “By using indigenous flora, we could target common illnesses such as strep infection and pink eye,” he continues.
Ever the teacher, Fine gives a mini lecture on germs. “We have to learn from our bacteria,” he states. “They’re not our enemies. They’ve been around forever and live with us because they’ve figured out a way to survive in our bodies. They can not survive and thrive unless they attach to a surface and integrate into a complex ecosystem.
“Now, envision your mouth from the perspective of its bacteria. Saliva is like an ocean to them. You chew and your saliva would wash away those bacteria if they had not developed this ability to cling to surfaces.
“Remember,” he says, “not all bacteria do harm. But we want to develop therapies to just dislodge the bad guys. Antibiotics use a scorched earth policy — kill everything. What we can now do is target the bad flora in the affected area and leave the good ones alone. This is a targeted therapy because it gets the drug to the bug and has a minimal impact on the natural ecological floral mix.” Fine’s UMDNJ collaborators in these projects include Narayanan Ramasubbu, PhD, Kabilan Velliyagounder, PhD, and David Furgang, PhD.
“Dry mouth is a problem with no real solution yet. This product will answer a big unmet medical need,” says Vince Smeraglia, Esq, director of UMDNJ’s Office of Technology Transfer and Business Development. “The oral rinse for dry mouth could really be a blockbuster, especially if it can be sold over-the-counter as a mouthwash. And it could be on the market in three to five years, compared with the seven to ten years that it generally takes to launch a new drug, such as a cancer therapy.”
“This is exactly what we are hoping for when we invest in UMDNJ research,” says James M. Golubieski, president of Foundation Venture Capital Group, LLC (FVCG), which was established in March 2006 as an independent organization investing in research at the University by funding new life sciences companies. Affineti Biologics has received a commitment of up to $500,000 from FVCG to advance its research.
Over the last five years, FVCG has invested in seven companies that began in UMDNJ research labs. One of those, Longevica Pharmaceuticals, Inc, which developed a chemoprotective agent that may keep normal cells healthy during cancer treatments, based on the work of Alexey Ryanzanov, PhD, associate professor of pharmacology at RWJMS, has already been sold to Rostock International, LTD, a subsidiary of a Moscow-based global investment firm.
“We can infuse the dollars from that sale right back into the laboratory to further other University research,” he says. Moving academic research into the marketplace to stimulate business and create jobs is particularly important in this down economy, since this is a historically untapped source of rich ideas and discoveries.
“Part of our mission is to make a real impact in the world of medicine. We’re not just in it for a return on our investment,” says Golubieski.
FVCG does not make its $500,000 award without its own long research process. After Smeraglia introduces promising lab research, FVCG closely reviews all the data. If it gives approval, the next step is “due diligence,” a third party review of the patent, the technology and the business plan. After due diligence, the Foundation Venture Board then considers the investment. Few proposed companies make the cut.
For those that do, FVCG makes an investment in the new company, providing funds and acting as the business consultant “to ensure that the investment is going to the research and clinical testing,” says Golubieski. “We want the researcher to concentrate on research.”
“Celgene started with a university invention. Amgen and Genentech did, too. PTC Therapeutics, a biopharmaceutical company that was started from a UMDNJ invention, now employs 175 in New Jersey,” Smeraglia points out.
“Winning just a small portion of Listerine’s more than one billion dollar U.S. market would be quite a win for all of us,” he concludes.