Gangstem Biotech "Preparing to Succeed in Developing Atopic Dermatitis Treatment"

Media Conference Day Held on the 25th, Presentation of Key Clinical Status and Commercialization Strategies

[Asia Economy Reporter Hyungsoo Park] Gangstem Biotech held the ‘2021 Gangstem Biotech Media Conference Day’ on the 25th at the Fairmont Ambassador Hotel in Yeouido.

Gangstem Biotech recently received IND approval for the phase 3 clinical trial of the atopic dermatitis stem cell treatment ‘Purestem-AD Injection’ from the Ministry of Food and Drug Safety. The media conference day was organized to announce the current status of Gangstem Biotech’s clinical trials and the commercialization plans for its major pipelines.

Kang Kyung-sun, founder and largest shareholder of Gangstem Biotech and GVO, introduced the changes and improvements aimed at the successful phase 3 clinical trial of the atopic dermatitis treatment.

The business status presentation was given by CEO Na Jong-cheon of Gangstem Biotech. CEO Na stated, "By applying cutting-edge cryopreservation manufacturing technology to the phase 3 clinical trial of the atopic dermatitis stem cell treatment, we can optimally maintain cell viability until patient administration." He added, "We have strengthened control over prohibited concomitant drugs and rescue medications to manage confounding factors in clinical results, thereby meticulously preparing the foundation for the success of the phase 3 clinical trial."

If commercialization is successful, ‘Purestem-AD Injection’ will become the world’s first stem cell treatment for atopic dermatitis. It is characterized by high convenience compared to existing treatments as a fundamental therapy with a single administration. The fact that no serious side effects were observed during a 5-year follow-up after administration, securing long-term safety, is also considered a competitive advantage.

CEO Na presented remarkable results from large animal (goat) experiments of Gangstem Biotech’s osteoarthritis treatment, including cartilage regeneration and inflammation reduction. While existing drug treatments were limited to pain and inflammation control, the cartilage regeneration effect is expected to pioneer a new area in the osteoarthritis treatment market as a novel drug.

Yohan Bae, head of clinical development at Gangstem Biotech, announced the clinical progress of Gangstem Biotech’s major pipelines. Head Bae stated, "The second clinical trial project name for Purestem-AD Injection is ‘FURIN’," and added, "We have increased the likelihood of clinical trial success by maintaining the highest cell functionality in the investigational medicinal product and introducing a patient-centered clinical trial design."

This content was produced with the assistance of AI translation services.