A gel without taste
A dry mouth, pain and difficulties swallowing are common conditions for patients with head and neck cancer, but help is on the way. Researchers at the Universities of Copenhagen and Southern Denmark have developed a gel without taste, the Zero Taste Gel, which effectively lubricates the mucosa and helps food on the way. The new company, Tenacious, was established in no time at all.
Eating together is an important social event, so if you are unable to eat, you easily risk being more or less cut off socially. This often happens for patients with head and neck cancer, because the treatment with radiation destroys mucous membranes, often leaving wounds.
"After the treatment, just drinking a glass of water is associated with pain. In some of the patients the salivary glands are completely destroyed, and they have to live the rest of their lives with a dry mouth without saliva. Pain-ridden patients are offered a local anesthetic before eating, but the drugs available today have significant side effects," says Daniel Bar-Shalom, Department of Pharmaceutics at the University of Copenhagen (UC).
He got the idea for the new gel a long time ago, but it took many years before he found a solution. But after that everything happened very fast!
The interest was aroused early in his career
The story begins many years ago, under foreign skies. Before Daniel moved to Denmark, he worked as a pharmacist in Israel, and down there, doctors sometimes ask pharmacists for help with challenges difficult to solve with the drugs available.
"One day, three doctors came into the pharmacy and asked me to help the patients with head and neck cancer, who were unable to eat. Solutions with the common local anesthetics tasted too bitter," Daniel explains.
He offered to help position the solution in the throat, so that the medicine, as far as possible, avoided contact with the taste buds. But it was definitely no satisfactory solution to the problem. Years passed, and Daniel moved to Denmark and started working at the UC.
Patients use ketchup
At UC, Jette Jacobsen became one of Daniel’s colleagues. She is now one of the five founders of Tenacious, and has been following the process all the way.
Jette is associate professor at the department, and one day she asked some of her undergraduate students to solve a problem on the formulation of the local anesthetic lidocaine.
At the same time, Daniel, just happened to have planned to attend a meeting held by the association for patients with head and neck cancer.
"I always tell our students: Is the purpose to make a tablet? No, the purpose is to help the patients! That’s why I invited the students to join me at the meeting," Daniel explains.
The visit was an eye-opener for the students, and for Daniel it became crucial to hear the patients share their experiences of eating.
"It was in many ways touching. One of them had given up. His wife had brought him there, because he no longer had the strength to eat," Daniel says.
The patients kept mentioning ketchup as lubrication to facilitate swallowing the food. This got Daniel thinking.
"I thought that a gel without taste might help them," says Daniel.
And then a few years later something happened ...
A random event made the difference
"One day a woman contacted me and asked for help regarding the ingredients of a massage gel. The product she brought had some very special properties, which precisely matched the needs for a gel for patients with head and neck cancer," says Daniel.
He still has some of the massage gel in a container, which he lifts and rotates in the air. The gel forms long threads inside the container, and is clearly extremely viscous.
"We started investigating which ingredients might be responsible for these properties, and before long we had the answer," says Daniel, who suddenly had the perfect starting point for developing a jello which could replace ketchup. Because the massage gel had absolutely no taste.
Already the following year, the research group had a finished gel, consisting of well-known, non-toxic ingredients already used in food and medicine.
Ideal for local anesthetic of the throat
The new gel has groundbreaking properties suitable for much more than lubrication for food. Some of the gel remains on the mucous membranes of the mouth and throat, and is therefore also suited as artificial saliva, possibly with a local anesthetic.
"It is a challenge to locally anaesthetize the throat, for what comes down that way, quickly passes on to the stomach. That is why we only have lidocaine today, which is efficient enough to anaesthetize quickly, but unfortunately tastes absolutely terrible! Some people even throw up when tasting it, and this leaves general anesthesia as the only option, if they have to go through something painful in that region. This is particularly true for children," says Jette Jacobsen, who is in the process of developing the next product for the company.
We have other drugs which taste better, but they require a longer time to work.
"In order to test whether the gel remains on the mucous membranes, we conducted experiments with riboflavin, which is fluorescent. We mixed riboflavin in the gel, took a spoonful, and examined whether the throat became fluorescent. It did!" Jette says.
A local anesthetic gel is a drug, which means there are special rules for approval and registration. It takes time to sort everything out, probably several years.
But as artificial saliva without anesthetic, the gel can go into production almost immediately, and this was one of the first goals for the researchers.
Quick as a flash
It took about half a year from the first time Daniel contacted CPH Spin-out until Tenacious IvS was formed, and the fast pace has been exciting.
It was only possible, because several important steps had already been taken.
- It took the scientists only a year to develop the product, which was ready when they contacted CPH Spin-out.
- The scientists had thought carefully about everything, and knew where they wanted to take the project.
So the project was almost ready, but without the superb partnership it would not have moved so fast.
The scientists highly praise Bo Stenhuus from CPH Spin-out for his efforts and not least his rapid response to all inquiries throughout the process.
On the other hand, Bo praises the researchers for their dedication, which spurred him to act as quickly as possible.
"It is very interesting to work with people who are so dedicated and so quick to act as the researchers behind Tenacious are. It provides synergy and raises the process to a whole different level," explains Bo.
In addition to the accelerated process, the University of Southern Denmark (USD) also entered the picture and demanded attention, since one of the co-inventors, Kasper Dalby, works over there. Today he holds 15% of the rights, and the two universities have agreed to let UC arrange all the details in connection with the establishment of the new spin-out. This happened without striking a blow.
No thanks to investors
Daniel has previously been co-founder of a pharmaceutical company, so he knew the drill. One of the challenges this time was that he under no circumstances wanted any interference from potential investors.
"I would like to have control myself . For this reason, I wanted a structure which didn’t require major investments, so that we could stand on our own feet from day one, not needing involvement from people outside," says Daniel.
A pleasant surprise
Today the researchers hold a saleable product, and this is the result of dedicated research and a little bit of luck.
"Think about how much of this story is due to coincidence. From the time when my interest was first aroused, while I was a pharmacist in Israel, until we hold this amazing massage gel and find out, that its special properties are due to interaction between two well-known and well-tested substances. There is an English word describing this – it’s called serendipity, and it means something along the lines of a pleasant surprise,” says Daniel.
The new company is called Tenacious IvS
Tenacious means stubborn, and refers to the gel that sticks on the mucous membranes.
IvS is the abbreviation of the entrepreneurial company, which is a new type of company which Ervervsstyrelsen (Danish Business Authority) has made for entrepreneurs. Read more
Besides Daniel and jette, co-inventors are:
The fast pace
Copenhagen Spin-out had a phone conversation with Daniel and received the first material.
The researchers provide the last signatures, and Copenhagen Spin-Out officially receives a so-called invention disclosure, a document describing the invention in order to evaluate the possibilities for obtaining a patent.
Copenhagen Spin-outs receives the results of the innovation study
Commercialization of the new company is discussed at a meeting with the inventors
The University of Copenhagen officially takes over the invention in order to form a spin-out
Copenhagen Spin-outs accepts the project, and approves the initial support budget.
Meeting with a patent attorney about a patent application
Copenhagen Spin-outs launches a market survey
A Freedom to operate (FTO) on the gel is received from the consultant
The patent application is filed
The parties begin negotiations on the terms of the new spin-out.
Blue book Daniel Bar-Shalom, 65 years old
2010 - now: Scientific consultant Bioneer A / S
2009 - present: Associate Professor, Department of Pharmacy, University of Copenhagen
2007 -2009: Vice President, CSO at IPC International Operations A/S 1988 -2007: Senior Vice President at Egalet A / S
1984 - Licensing examination, The Hebrew University
Daniel is married to Eva, who is Danish and works with Doctors without Borders. They have two children: David, a lawyer, and Dana, a doctor. Daniel and Eva moved to Denmark when Eva, after 15 years in Israel, missed her home country. Daniel does not regret this - he is particularly fond of the informal tone that dominates at most Danish workplaces.
Blue book Jette Jacobsen, 51 years old
2000 present: Associate Professor, Department of Pharmacy, University of Copenhagen.
1996-2000: Assistant Professor, Department of Pharmaceutics, Faculty of Pharmaceutical University.
1995-1996: Research and Teaching Assistant, Department of Pharmaceutics, Pharmacy at college.
1991-1995: PhD student, Department of Pharmaceutics, Pharmacy at School 1983-1986: Pharmacy Assistant Student, Næstved Løve Apotek.
For Jette it is ideal to work with pharmacy, because she gets to use both her head and her hands while working. In addition, she is dedicated to convey her field to the committed students who have chosen to become pharmacists.
Working at Tenacious is a new challenge for Jette, who sees it as a great opportunity to practice interdisciplinary research as well as to obtain ideas from the lab all the way out to the end-users.