KOLON TissueGene resumes Phase III clinical trial for TG-C in the US

KOLON TissueGene resumes Phase III clinical trial for TG-C in the US

- World’s first cell and gene therapy for osteoarthritis, TG-C, anticipated to gain speed with clinical trials

• Targeting to become the first disease modifying osteoarthritic drug (DMOAD) to obtain approval

- Clinical trials beginning on December 27, 2021 (US Western Standard Time) at approximately 80 clinics across the United States

- Plans to complete administration to patients enrolled in Phase III clinical trial by 2023

- Phase II clinical trial for osteoarthritis of the hip also approved, enabling expansion of TG-C indications and proving its safety

KOLON TissueGene, Inc. (Co-CEOs Moon Jong Noh, Sung Han) resumed administration of TG-C, the world’s first-in-class cell and gene therapy for osteoarthritis (OA), to patients with knee OA who enrolled in the phase III clinical trial in the United States.

KOLON Tissue Gene (“Company”) announced on December 28, 2021 that the injection of TG-C to patients enrolled in the clinical trial was reinitiated on December 27 (WST) at Source Healthcare in Santa Monica, California. The Company plans to complete the injection to a total of 1,020 patients (including 11 patients who already completed the clinical trial) at around 80 clinical centers across the US by 2023.

Unlike the traditional treatments of knee OA such as surgery, opioids or physical therapy, TG-C is a first-in-class cell and gene therapy that treats the disease through an intra-articular injection on the knee.

The Company designed the clinical trial so that TG-C can be approved as a Disease-Modifying Osteoarthritis Drug (DMOAD) that not only controls pain and improves the function, but also enhances the structure of the joints. To date, no drug has been acknowledged as DMOAD globally.

As the injections resumed after the Food and Drug Administration (FDA) acknowledged the cumulated performance of the Company’s scientific clinical data, the phase III clinical trial of TG-C is anticipated to gain progress and speed.

Other achievements for the Company included expansion of the clinical indication and reconfirmation of the safety of TG-C, as the FDA recently approved the clinical trial of TG-C on hip OA patients.  The FDA allowed the Company to skip the investigational new drug (IND) application and phase I clinical trial, and progress straight into the phase II clinical trial.

Approximately 38 million patients are suffering from osteoarthritis in the United States, of which around 20 million are given prescriptions for knee OA symptoms (Simon-Kucher, 2020). Furthermore, according to “Osteoarthritis? Global Forecast 2014-2024” published by Globaldata, the market size of OA in the major countries around the world is expected to increase from USD 7.6 billion in 2021 to USD 9.2 billion in 2024, predicting an average growth rate of 8.26% per annum.

Co-CEO Sung Han of KOLON TissueGene remarked that “TG-C injections to the enrolled patients will be completed by 2023. As the scientific data of phase I and II clinical trials are still effective and highly trustworthy, we are expecting promising outcomes from phase III. We hope to complete the clinical trials successfully so that TG-C can become a game-changer not only in the US but in the global OA market as well.”

Specialists from around 80 university hospitals and professional clinics that have been playing pivotal roles in treating OA in the US including Mount Sinai Hospital, New York University and Rothman Orthopedic Institute are participating in the phase III clinical trial as the trial investigators.

The FDA had issued a clinical hold against KOLON TissueGene in May 2018, after which the Company had to submit an explanation on why the origin of the TG-C 2 allogenic cell had been mislabeled, together with additional experimental data regarding the characteristics of the cell. After thoroughly reviewing the experimental data submitted by the Company, the FDA commented that all of the issues related to the clinical hold issued against TG-C had been resolved with satisfaction and lifted the clinical hold in April 2020. The Company reinitiated phase III clinical trial and resumed injections to patients after the process of selecting the hospital, enrolling patients and preparing the specimen was completed.