AYER -- For Lynn and David Paolella, Wayland residents and founders of Cambrooke Therapeutics, it began close to home, with their own two children.

Both born with a rare medical disorder called phenylketonuria, or PKU, that prevents the children from consuming most foods that other people take for granted, Lynn Paolella, in particular, found herself challenged in coming up not only with meal plans, but with food that just tasted good.

One thing she quickly discovered was that the state of specially prepared medical foods at the time was poor and offered little in the way of variety.

Forced to explore her own resources, the psychology undergrad, with no direct experience in the field of dietary nutrition, turned her kitchen into a laboratory and began experimenting to find ways to make food her children enjoyed eating.

"People with PKU cannot consume any normal proteins," explained Cambrooke CEO Marc Tewey. "If they don't adhere to a strict and specialized diet, they can eventually become mentally handicapped. But if their diets are managed properly with medical foods, they can remain perfectly healthy."

According to Tewey, general screening for the disease began with newborns in the 1970s. Today, as many as 20,000 people have been diagnosed with PKU in the United States.

"Basically, people with PKU lack an enzyme in the liver that metabolizes a protein, phenylalanine, an amino acid found in all protein," said Paolella.


"Because they have difficulty metabolizing phenylalanine in protein, they need to go on a very restrictive diet and supplement it with a high protein formula that contains all the other amino acids, vitamins and minerals minus the offending amino acid."

People suffering from PKU are limited almost exclusively to vegetables, with eggs, milk, cheese, fish, meats, legumes, soy, tofu, as well as anything made with wheat or flour all to be avoided.

"It was absolutely devastating," said Paolella. "I wondered how was I to feed my kids? I had to go on a steep learning curve. I couldn't even pronounce phenylketonuria then.

"But as time went on," she said, "it became important to me that my children didn't feel different from other kids. I kept that in mind when I began to create interesting tasting products for them. I would create different kinds of foods and take them to school and see what other kids thought of them. They would tell me how to dial it up or dial down flavors and textures or how to change my products to make them taste better. My kids' friends knew that when they came to our house, they had to taste my latest creations as I relied on their feedback."

Unlike the increasingly common peanut allergies that can be treated simply by omitting peanut-based foods from a person's diet, PKU patients still require certain proteins that their bodies will reject. Because they suffer from a metabolic disease that is genetic in nature, specially engineered foods must be created for them

"Before Lynn came along, bread for PKU patients came in a can," said Tewey. "It was horrible-tasting stuff. She's been a huge benefit to the PKU community, improving those kinds of food items that years ago were the only ones available."

"I loved to cook and designed products that were low in protein," said Paolella. "My very first food was bread. I'd seen some bread in a can distributed by a European company but the product was discontinued around the time bread machines for home use were first being marketed. Soon, every PKU mother had one because they all had to make bread from scratch."

Eventually it came to her that if she was having so much difficulty finding good tasting food for her children to eat, others must be facing the same difficulties. How could she help them and herself at the same time?

Enter Cambrooke Foods, a medical foods manufacturer and distributor begun in 2000 by Paolella and husband David.

"The name Cambrooke came from my two children, Cameron and Brooke," said Paolella. "We founded the company initially to provide low-protein foods to help manage the inborn errors of protein metabolism diet. Since then, the company has grown to include therapeutic formulas for PKU and other rare diseases."

In addition to a bakery in Brockton, the Paolella's moved into a vacant building at 4 Copeland Drive, where they develop, market and distribute their food and formula products to points around the world.

"It used to be owned by a defense contractor," said Tewey of the site. "It had good infrastructure and was located in a little cluster of other businesses. It's a good area for us."

But getting the business off the ground was not as easy as it appeared. In the beginning, the Paolellas had a hard time finding partners to help manufacture their product. Most thought their manufactured goods lines were too narrow and thus potential sales too small to become involved but eventually, some gave them a chance.

"There are some in the field out there with a good heart," said Paolella. "We started out with them and they hoped to see us grow."

And so they have, with the Ayer facility currently employing 35 people.

Having done business as Cambrooke Foods for the last 14 years, the Paolellas recently decided to change the name of the company to Cambrooke Therapeutics to better reflect an expansion of its services.

"In academia, they're developing interesting new products but somebody has to turn it into a food that real people are going to eat and enjoy every day," said Tewey. "That's a big challenge. That's when we partnered with the University of Wisconsin. We take the medical foods foundation they provide and turn it into something people will eat."

Much of the medical foods and formulas produced by Cambrooke come in the form of drinks, bars and shakes that supply patients with all of their protein requirements.

"The company has done a lot of work in the field," Tewey said. "The next step for us is to take what we've learned and move into new therapeutic areas. Nutrition can help to manage such things as weight loss or cholesterol reduction, but there's really no other field of medical nutrition treatment like PKU, where the consequences of miscalculation are so dramatic. You can manage PKU with a diet if it's done properly but if it's done wrong, people will get profound neurological disorders.

"We are committed to innovation and meeting the needs of patients who would otherwise have limited or no choice in treatment options," said Paolella. "We are going to take the skills and dedication that delivered on our success in PKU and use our core strength of working with academia to create commercially viable nutritional therapeutics based on medical science to help others."

For information about Cambrooke Therapeutics and its products and services, those interested can visit cambrooketherapeutics.com.