Bone Therapeutics, who are developing an allogeneic bone cell therapy as a treatment for delayed-union fractures of long bones, has announced the results of a Phase 1/11A study. They have also said that they are changing the production process of the experimental therapy to optimise it. For more detailed information you can read the source press release here, at Bio Portfolio.
About Delayed-Union Long Bone Fractures
According to Medline Plus, long bones are a type of bone in the body that is hard and dense and provides structure and stability, such as certain bones in the leg. These bones may fracture, also known as a broken bone. Bone Therapeutics’ say that a long bone fracture is ‘delayed-union’ if it hasn’t healed within the expected normal period after the injury, which is typically a three to four month period.
When fractures don’t heal in the expected time, Bone Therapeutics says, doctors may offer surgery or take a waiting approach. Bone Therapeutics’ investigational allogeneic bone cell therapy, called ALLOB®, is designed to provide another treatment option to patients and doctors that wouldn’t require major surgery.
About the Study
The Phase I/IIA trial took place over six months and involved twenty-one patients. It was an open-label study designed to investigate how safe and effective ALLOB is as a therapy for delayed-union long bone fractures. Each patient was given the drug once, and then followed-up over six months.
All patients who completed the study showed an improvement that met the study’s primary endpoint (an increase of two or more points on a radiological TUS, or a 25% improvement using GDE scores). Approximately three-quarters of patients met the TUS measurement goal, while the same amount reached the GDE score goal.
Production Process Changes
Bone Therapeutics has also announced that it will change the production process of the drug, to increase the amount produced and make it easier to ship and freeze at hospitals. These changes are expected to be in place for future clinical trials.
For more information, you can view the press release from Bone Therapeutics here.