Experimental therapy is in early-stage trial By Terri Somers, Union-Tribune Staff Writer
A subject in the early-stage clinical trial of hair regrowth therapy ReGenica before treatment (left) and after 12 weeks (right). (Histogen photos) -
If your forehead is more like a fivehead, or you’ve started to see a lot more scalp at the crown of your head, the tiny San Diego biotechnology company Histogen has some promising news.
The company today is unveiling preliminary results from an early-stage clinical trial that showed its experimental hair regrowth therapy, ReGenica, increased new hair growth and the thickness of existing hair in men after 12 weeks.
“These results appear to be phenomenal, although this trial is still in the very early stages,” said Los Angeles-based hair transplant specialist Dr. Craig Ziering.
“Wimpy hairs became thicker, which is pretty significant to the patient because even if you cannot increase the numbers of hairs, if you increase the diameter, you increase the volume. And preliminary hair counts show there was an increase in new hair of 15 to 20 percent in some patients,” said Ziering, a paid member of the company’s scientific advisory board.
ReGenica is made of a cocktail of proteins that are present in the early-stage embryo and help direct stem cells to become either hair, bone or blood, said Histogen Chief Executive Gail Naughton.
Although scientists have known about the role these proteins play, Histogen’s aha moment was figuring out how to create them in a lab, said Naughton, who is also dean of San Diego State University’s School of Business Administration.
Fibroblasts, early-stage stem cells that form connective tissue, are grown in the simulated low-oxygen and free-floating, low-gravity conditions of the embryo, Naughton said. The important Wnt proteins and growth factors then build up in that environment, she said.
The 18-person company, which opened in 2007, conducted research showing ReGenica stimulated hair growth in animals. It started its Phase 1 human trial to show the therapy was safe; no dangerous side effects were experienced, Ziering said.
Histogen was also hoping the trial would show ReGenica’s effectiveness, which might give the company the buzz it needs to raise funding, build a manufacturing facility and then begin Phase 2 trials, Naughton said.
The Phase 1 trial involves 25 men ages 18 to 45 who have varying stages of male-pattern baldness.
Each of the balding spots was mapped into quadrants. Each quadrant received an injection of either the drug or a placebo. Some of the quadrants were also treated with microdermabrasion or lasers as well as the drug, to test previous medical theory that a wound helps to stimulate stem cells in the skin to regenerate hair follicles.
At 12 weeks, penny-size pieces of scalp were biopsied to observe the changes. Histogen staff even counted the follicles and hairs sprouting out of them. Once the trial is completed, an independent data-monitoring board will review the results after five months and make an assessment.
More than 50 million men in the United States alone suffer from hair loss, and about 35 million women are dealing with the problem, said Ziering, who has been treating patients for hair loss for 18 years.
“There’s a tremendous need for something that can help people with their hair loss because there are many ramifications on people’s lives,” Ziering said.
Histogen’s product shows promise to do multiple things, including slowing the progressive nature of hair loss, increasing the thickness of the follicles and actually getting new follicles to grow, the physician said.
Histogen also sees ReGenica as a means toward lifesaving therapies that trigger stem cells to generate new tissue in damaged heart muscle and new neurons in damaged spinal cords, Naughton said.
“We wanted to go after a market where there is really an unmet need and a large patient population, which could help us generate the cash flow to fund longer-term projects that would be more of a regulatory and reimbursement hurdle,” she said.