JangoBio says human trials possible next year
JangoBio, a biotech company developing a therapy to reduce the negative effects of aging, could be starting human trials as early as next year.
That’s according to company COO Bill Kohl, who spoke alongside CEO Craig Atwood at a recent progress update for interested parties at the Foley & Lardner law offices in Madison.
The company’s proposed method for reducing these effects, including the progression of age-related diseases, involves regrowing key cells in the body that are responsible for keeping hormones in balance.
As the body ages, tissues break down and biosynthesis of sex hormones is diminished in a condition called hypogonadism. In an attempt to slow, stop or even reverse this process, JangoBio plans to apply stem cells to regrow these vital tissues.
The team is currently refining cells in vitro, which means the refinement is taking place in a test tube or culture dish, or anywhere outside a living organism.
“We’re attempting to select the best candidates to move through the clinical pipeline, and we have some good, solid in vitro data demonstrating that we can differentiate these cells down a path that we need,” Atwood said.
Once that’s done, he said, the JangoBio team is going to bioengineer some of the cells to produce certain key factors, so that when the cells are injected into a human or animal, they will differentiate into cell types that are needed to correct the hormone imbalance that happens naturally as people and animals age.
“Following that, we’re going to then assess safety and effectiveness of course, and then we would commence animal studies,” Atwood said.
One of the company’s target markets is companion animals; that's easier to break into than the human market because of the varying FDA regulations and requirements.
Atwood says that while the company will be pursuing companion animals, it will also continue to pursue the human market by conducting good laboratory practice studies, also known as GLP studies, in order to generate crucial safety data. This data is needed for the company to obtain an investigational new drug application to be able to start up Phase 1 human clinical trials.
“The timeline for all this is pretty short, because we can get into animals pretty quickly; we actually think we can get into humans faster than we thought,” Kohl said.
He says the autologous method of stem cell cultivation, in which cells are harvested from the patient’s own body, is being performed by stem cell clinics all over the world right now, including in the United States.
“They’re having spotty successes. Some are having more successes recently, which is encouraging, but we’re talking with a couple of well-renowned stem cell clinics now about doing autologous work for us,” Kohl said. “We’re going to start doing [testing] in humans as early as next year potentially, in 2018.”
Atwood predicts a wide-open market, as hormonal changes are “very integral” to the development of many diseases of aging.
“Not only can we target the market of hypogonadism, we can also target the market of hot flashes, and insomnia, Alzheimer’s disease, type 2 diabetes,” he said. “So again, the market is absolutely enormous, and with this single therapy -- which I believe gets at the heart of the aging mechanism -- we will be able to halt the progression of many different diseases.
--By Alex Moe