Tego Science said Wednesday that it has applied to initiate phase 3 clinical trials for TPX-114, a rotator-cuff tear rejuvenation cell therapy, to the Ministry of Food and Drug Safety (MFDS).
Rotator cuff tear is a tendon rupture that happens due to excessive use of muscles or tendons in the shoulder area and stimulation or strong external impact. Such fractures can cause musculoskeletal, cartilage and bone diseases.
Selected as an Advanced Technology Center’s (ATC) project in 2016, TPX-114 uses the same cell culture technology as Rosmir, a recently approved drug for the wrinkle-improving cell therapy.
The ATC project, under the auspices of the Ministry of Trade, Industry and Energy, selects private research institutes with excellent technology potential, gives them technology development fund and fosters them as world-class research organs armed with world-class competitiveness.
Under the project, TPX-114 will receive 1.92 billion won ($1.77 million) in government grant for four years to help finance its total budget of 2.88 billion won.
According to the Health Insurance Review and Assessment Service (HIRA), the number of patients with rotator cuff tear rose by 88.9 percent in six years from 342,000 in 2010 to 647,000 in 2016.
The number of patients with rotator cuff tear has been increasing steadily due to aging and sports leisure activities, but there is no ultimate cure to help regenerate and recover the tendon itself. Currently, only a surgical procedure that provides a physical connection with the muscle is available. However, the recurrence rate is high making it difficult to cure fully.
If approved, the company expects that TPX-114 will become Korea’s first therapeutic agent for cell therapy to regenerate tendons.
“This year, we will speed up the development of various cellular therapeutic drug pipelines,” a company official said. “As soon as the company completes clinical trials of TPX-114, it plans to commercialize the treatment and lead the market for cell therapy products related to regenerative medicine such as rotator cuff and Achilles tendons.”