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Westchester County Business Journal: Gut Reaction Drives Biotech CEO
Friday, October 30th - 2009
CEO Joan M. Fallon has not courted the venture capital community to fund the small biotech company in Rye she founded five years ago.
“They have templates,” Fallon said of VC investors. Set-in-stone templates don’t apply to her professional odyssey and commercial venture in pharmaceuticals.
A chiropractor specializing in pediatrics, Fallon for 25 years ran a thriving private practice from offices in Bronxville, New Rochelle and Yonkers. She also taught physiology and developmental biology as an assistant professor of natural science and mathematics at Yeshiva University. A former board member at Oxford Health Plans, she pushed successfully for groundbreaking state approval of health insurance underwriting for alternative and complementary medicine such as chiropractic. Now she heads Curemark L.L.C., a drug development and research company whose first commercial candidate, the proprietary drug CM-AT, is in Phase III clinical trials nationally as a digestive treatment for autism in children.
“The gut-brain connection,” said Matthew F. Heil, Curemark senior vice president of drug development and manufacturing, describing the unique treatment and the connection Fallon first made between digestion and autism in children in her chiropractic practice.
“This approach actually touches multiple diseases and it’s a new pathway to a lot of diseases,” Heil said.
Trained as an immunologist, “I come out of traditional medicine,” he said. “Gut doesn’t cause behavior.” Yet he was persuaded by the mathematical data Fallon collected in her clinical tests of autistic and non-autistic children and joined the company in 2006. “Data doesn’t lie,” he said.
“He was the first person I met who validated what I was doing,” Fallon said of Heil.
Curemark, which Fallon started in 2004 with money from family and friends, recently closed a $6.5-million round of private funding. Fallon said $3.5 million of that was raised in just two weeks, after the national Centers for Disease Control and Prevention announced a new study showed that much higher numbers of children in the country were affected by autism than previously thought – 1 in 91, and about 1 in 58 boys, or approximately 1 percent of all children in the U.S.
Two weeks ago, Curemark opened a $20 million funding round to build its pipeline of drug applications for autism and other neurological diseases, including attention deficit hyperactivity disorder, or ADHD, diabetic neuropathy and Parkinson’s disease.
Lower Westchester, where Fallon practiced, “has a huge number of children with autism,” higher than both the South Bronx and northern Westchester, she said. In the early ’90s, the chiropractor started seeing its symptoms in children in her office, many of whom were brought to her for treatment of ear infections. “It really wasn’t ear infections; it was autism,” she said.
Those patients showed varied symptoms of neurodevelopmental disorders, labeled “the autisms” by geneticists, that Fallon and other researchers theorize have genetic underpinnings but more than one cause. “The thing that didn’t vary for them was what they ate,” she said. “For the most part, that’s just carbohydrates – white food and devoid of protein. That’s when I started looking to see what that might be.”
The chiropractor began to apply a theory that autistic children might avoid protein in their diet because they could not digest it. Finding those patients had high levels of bacterial antigens in their intestines and lacked or had little of a protein-digesting enzyme in stool tests, “I started testing every child in my life,” she said.
Fallon tested 463 children between the ages of 2 and 8, of whom 266 were diagnosed with autism while 197 had no known condition. She examined them for levels of fecal chymotrypsin, the protein-digesting enzyme secreted by the pancreas that is the biomarker for Curemark’s therapeutic approach to autism. Her tests showed 76 percent of children with autism had abnormally low levels of the enzyme compared with 1.5 percent of healthy children.
Lacking that enzyme, the body cannot break down eaten proteins into amino acids, the building blocks of new proteins essential for brain function. The undigested protein becomes an allergen in autistic children. The altered gastrointestinal tract is overgrown with bacteria, yeast and additional infection.
“It’s simplistic,” Fallon said of her discovery. “It’s not complicated. And people said to me, ‘How did you think of that?’”
In 1999, Fallon filed her first patent application for the use of chymotrypsin in treatment of autism, attention deficit disorder and pervasive developmental disorder. She did so at the urging of her brother, James J. Fallon, a Westchester inventor and retired aerospace engineer who holds several patents for satellite sensors and techniques to accelerate data storage and retrieval.
Her first patent was granted in 2003, the year before she formed her company. In the last decade, Fallon has had four patents issued and has filed 32 patent applications. While continuing her research and working to commercialize her findings, she also earned a master’s degree in clinical investigation from the Harvard Medical School’s joint program with Massachusetts General Hospital in Boston.
“I didn’t think I wanted to start a biotech company,” she said. “I was very happy in my life. I had a wonderful practice. I enjoyed the children. But sometimes you have to do things. I had to see this thing through.”
From 1999 to 2005, Fallon developed the enzyme-bearing digestible powder now in clinical trials. Sprinkled on a child’s food, “We had to find a way to deliver it to them that was palatable and accepted.”
That has been solved with Curemark’s licensing in 2006 of a technology platform from Balchem Corp., based in New Hampton in Orange County, that encapsulates the enzyme for delayed release in the small intestine. “It’s specifically targeted in the GI (gastrointestinal) tract,” Fallon said. “There is nothing else like it in the world.”
Heil, whose pharmaceuticals industry contacts brought together Balchem and Curemark, called the exclusive licensing partnership “a great marriage.”
In September 2008, Fallon hired Elisa Zinberg as senior vice president of operations. In her former chiropractic practice in midtown Manhattan, Zinberg knew of Fallon’s chiropractic work with children. When a broken wrist forced her to give up her practice, she pursued a career in health care management. Fallon was impressed by her performance as chief operations officer at The Masters Circle Inc., a small, privately held practice management and leadership development company for chiropractors in Jericho, Long Island, that Zinberg had grown into a multimillion-dollar worldwide business. She was recruited for Curemark’s management team “to take it from a one-person operation to a large corporation,” Fallon said.
In her first day on the job, Zinberg was handed an investigational new drug application, or IND, to submit to the U.S. Food and Drug Administration. Based on Fallon’s clinical data, the FDA allowed Curemark to proceed this year to Phase III clinical trials with autistic children.
Recently those trials began at a pediatric clinic in Florida. Overseen by psychiatrists, they will also be done at 11 universities and medical centers of excellence around the nation, including Mount Sinai Medical Center in Manhattan. The trials will include 170 children between the ages of 3 and 8.
They are expected to be completed in one year. Zinberg said Curemark wants to launch its product in the second quarter of 2011. “We have all the pieces in place,” she said.
“We’re hoping it’s efficacious. We’re hoping it’s going to change the symptoms” of autism, Fallon said. “We want to make sure that the subset of children it will help, will get this drug.”
“Regardless of what causes autism, in some cases this (enzyme deficiency) is very much a part of it…It’s still considered a behavioral disorder. We’re hoping to show it’s a physiological disorder. That will be as much a help to the children as anything,” she said.
Curemark has 10 employees at its office in a Regus business center at 411 Theodore Fremd Ave. in Rye and “a lot of consultants,” Fallon said. “As a company we’ve pretty much stayed under the radar screen. We felt that it was important just to work on what we were doing and not talk about it.” Having reached the talking stage, Curemark has retained Rubenstein Public Relations Inc., the well-known Manhattan firm.
“It’s been a journey,” Fallon said.
- By John Golden
