New combination therapy could give diabetics independence from insulin
CHARLESTON, S.C. (WCIV) - The terrible twos for Patrice Cocco's son really were terrible.
"I called the pediatrician and said, 'How do you potty train a kid like this?'" she said.
Her son, Louis, wet through his diapers during the day and just couldn't get enough to drink. His pediatrician tested his blood sugar. It was five times the normal level.
"Right to the children's hospital we went," said Cocco. "We were there for three days and got the crash course.
Louis was diagnosed with juvenile diabetes.
"Your head is spinning and off you go with your baby and needles and insulin," she said.
At the time, Cocco was dealing with a thyroid problem of her own and seeing endocrinologist Dr. Claresa "Resa" Levetan.
"When I told her about my son she was floored," said Cocco. "She was like, 'I want to meet him.'"
Dr. Levetan was working on a drug to treat diabetes.
"She always called Louis her boss," said Cocco. "She says, 'I'm working for you. I'm working to get you off insulin so that means you're my boss. I'm working for you."
Dr. Levetan made Louis a promise: she would get him off insulin by the time he was an adult. Eleven years later, she has a drug ready for FDA approval.
"This is the most excited and optimistic I have been for a company before," said Dr. Ryan Fiorini.
Fiorini is the CEO of Dr. Levetan's latest venture, Perle Bioscience, Inc.
"I have been blessed with making some great decisions in life," said Fiorini.
"Some of it is likely luck, but the one thing I have never done is seen a drug get to market to save people," he said.
Fiorini's background is an unusual mix of business and medicine. He has a Ph.D. in microbiology and immunology from the Medical University of South Carolina, an MBA from the Citadel and a MHA from MUSC.
He founded and later sold Immunologix Inc., a company that developed technology to produce human antibodies from discarded immune tissue.
The Charleston Business Journal named him one of the top "Forty Under Forty" entrepreneurs in 2010 for his professional and community leadership.
Now he's tackling diabetes.
"We are starting phase three human clinical trials both in the United States and Europe," said Dr. Fiorini. "That means we are super close to getting these drugs out to the public and eliminating the need for insulin shots or pumps."
So what are the drugs and how do they work? That's where creator Dr. Levetan comes in. She's been working in Philadelphia.
The Emory University School of Medicine graduate has been internationally recognized for her work in diabetes and her research has been published in several medical journals, including the American Journal of Medicine.
Her excitement buzzes through the phone during a phone interview as she tries to put in layman's terms what she's found.
"What our group is doing for the first time is putting together a regeneration therapy with an immune blocker so that children with Type 1 diabetes can not only make new insulin producing cells, but they can be protected from the immune attack," she said.
Essentially, Dr. Levetan says she's found a way to not only create cells in the body that produce their own insulin, but protect those cells from the body's natural response to attack anything new or foreign.
No, it's not a cure for diabetes, because most likely the patient will have to continue to take the two pills for the rest of their life. But it means someone with diabetes would no longer have to take insulin to control their blood sugar, just like before they were diagnosed with Type 1, or juvenile diabetes.
What's more, the combination therapy uses two drugs that are already FDA approved. One is available over the counter and typically used for heartburn. The other is a low dose immune suppressant that requires a prescription. They could be used together for juvenile diabetes or separately for Type 2 diabetes, typically developed later in life.
The bottom line is this: Perle Bioscience now has a patent to combine the drugs to treat diabetes.
"We have a long way to go," said Dr. Levetan. "But we are tackling it in a way that nobody else has tackled it."
So does it work? Well, that's where the story goes back to Louis Cocco.
"This past summer I had him try the regeneration agent," said Dr. Levetan. "We were able to reduce his insulin by 80 percent in only seven days of treatment."
The regeneration agent, or the one that helps the body make new insulin producing cells, is available over the counter and already FDA approved.
"It was amazing how much we reduced his insulin," said Louis's mom Patrice Cocco.
But it was just a test.
"He was bummed, what do you mean we have to stop?" said Cocco. "He just wanted to keep going."
Louis wasn't the only one.
Linda Coleman is also one of Dr. Levetan's patients. She found out she had diabetes three years ago.
"I just started feeling bad," said Coleman.
Then 54 years old, Linda's husband rushed her to the hospital where doctors found her blood sugar level at a whopping 700 mg/dl. She was immediately checked in.
"What was really scary for me was that my vision was starting to change," she said.
Coleman started insulin treatments, watched what she ate and exercised. Her diabetes was managed, but she says she felt trapped by counting carbs and what she calls "going to shoot up" every time she ate.
She too tried part of Dr. Levetan's therapy for a couple of weeks last September. She's been off insulin ever since.
"Oh you can't imagine," said Coleman. "I'm amazed."
Susan Pierce tried it, too. Diagnosed at 10 years old, she's had diabetes for more than 30 years.
"It helped me decrease my insulin 50 percent," said Pierce. "That's remarkable. I am device dependent."
Pierce has tried every pump and monitor. She says just one part of the therapy for a little while was promising and freeing.
"I would prefer not to wake up and think about it," said Pierce. "To not think about every single bite, it's the constant thing in my head."
But she's not the only one thinking about it.
"Dr. Levetan will not stop," said Patrice Cocco. "One hundred percent of the time her mind is on this. If she's not going to do this, it's not going to get done."
"I have made Louis a promise," said Dr. Levetan. "I'm going to get him off insulin before he's grown up."
Dr. Levetan made a video of Louis when he was just 7 years old called "The Diabetes Boss." In it, she asks Louis what it would be like to not have diabetes. He says, "Like walking on a cloud."
Louis is now 13 years-old.
Remember that diabetes drug Dr. Levetan was working on when the two first met? She developed it and sold it in 2010. It's a regenerating drug that would most likely be used for Type 2 diabetes.
It has yet to hit the market, but the deal was worth $335 million.
She could have walked away. Instead, Dr. Levetan marches on. For Louis and other like him, she's still searching for that cloud, that little piece of heaven.
Pearl Bioscience hopes to have FDA approval to start its clinical trials this fall. If you'd like to learn more, go to www.PerleBioscience.com.