July 25, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WALTHAM, Mass. – The future looks bright for Massachusetts-based Histogenics (HSGX) as it looks to complete a 17-year journey with the approval of its proprietary NeoCart replacement cartilage technology.
Like other personalized medicine programs, Histogenics’ technology harnesses the body’s own cells to engineer a treatment, in this case, new cartilage that can be surgically placed in a patient’s knee to alleviate knee pain from osteoarthritis. The loss of cartilage is one of the leading causes of osteoarthritis.
“Something really special is happening with our product,” Adam Gridley, president and chief executive officer of Histogenics, told BioSpace in an exclusive interview.
The NeoCart product is not intended merely as a replacement of cartilage, Gridley said it’s designed to “regenerate and turn back time” for patients.
“It’s really an elegant and simple product,” he said. “We’re trying to harness body’s ability to make new cartilage – the only area in the body that doesn’t have any innate healing abilities. The new cartilage mimics the cartilage you had when you were a teenager.”
Histogenics, which currently has 45 employees, has been in developing NeoCart or 17 years. It is a cartilage-like, tissue-engineered implant created from a patient’s own cartilage cells. During the eight-week manufacturing process, a patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to organize and function like cartilage cells. The product is then placed in the knee using a proprietary bioadhesive.
Earlier this summer, Histogenics completed enrollment in its Phase III NeoCart trial and expects to report top-line, one-year superiority data in the third quarter of 2018, followed by a potential Biologics License Application (BLA) filing. If all goes as hoped, Histogenics could launch NeoCart by 2019.
If NeoCart continues to meet expectations throughout the late-stage trial and earns regulatory approval from the U.S. Food and Drug Administration, Gridley expects NeoCart will become a strong option for patients and physicians. The technology will provide patients with more consistent and less-invasive options instead of silicone injections that don’t always work or knee replacement surgery. Currently, NeoCart is administered through a minor surgical procedure, but Gridley suspects that eventually it could be done arthroscopically.
The Phase III trial is comparing NeoCart to microfracture, the current standard of care for the treatment of articular cartilage defects. The primary endpoint of the trial is a dual-threshold responder analysis measuring the improvement in the pain and function of each patient treated with NeoCart compared to those treated with microfracture one year after treatment.
Gridley said the microfracture treatment provides a narrow window for patients and doesn’t conclude in sustained long-term results. With NeoCart though, Gridley said anecdotal information from physicians conducting the studies suggests the product has a long-life for patients and also leads to a shorter recovery time—about three to nine months on average.
“We’re not seeing a difference between the native cartilage and NeoCart,” he said. “If you can get a patient back to work quickly, that’s a big deal.”
If NeoCart is approved, Gridley said the company is prepared to handle the logistics of developing and shipping the product across the country. He said NeoCart is stable and would not have any issues in transport.
“Logistics have been one of our biggest focuses. We’ve been preparing for 15 years to manufacture this to scale,” Gridley said.
If NeoCart earns approval, Gridley suspects the company will begin looking at other uses for the technology, particularly for ankle and shoulder injuries.
“If you can fix cartilage in the knee, you can fix it elsewhere,” Gridley said.
As Histogenics gets closer to that hoped-for regulatory approval, Gridley said the company should see some expected growth, particularly in hiring employees to handle the new product. Not only will the company need a sales force, but because Histogenics plans to manufacture the product, Gridley said the company will also need to hire additional employees to assist in the production.
