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Stem Cell Therapy
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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Affiliate PMT Australia Approves Phase 1/2a Clinical Trial
01
2024.08
Kangstem Biotech's affiliate, Primoris Therapeutics, has received approval from the Australian TGA(Therapeutic Goods Administration) for a Phase 1/2a clinical trial of PMS-101, an exosome-based burn treatment.
Kangstem Biotech's affiliate, Primoris Therapeutics, has received approval from the Australian TGA(Therapeutic Goods Administration) for a Phase 1/2a clinical trial of PMS-101, an exosome-based burn treatment.
PMS-101 is a stem cell-derived exosome therapy designed for burn treatment. Exosomes are known for their exceptional tissue regeneration and inflammation suppression properties, which make them highly effective in treating burns by promoting skin tissue regeneration and healing after inflammation.
Current burn treatments using skin cells are often expensive and less effective compared to standard dressings, which limits their practical application. Primoris Therapeutics’ hydrogel patch formulation, however, accelerates tissue regeneration at the burn site, reducing the time required for skin re-epithelialization compared to traditional dressings. Animal studies have demonstrated that PMS-101 enhances the growth of new skin tissue by 45% compared to untreated areas and 23% compared to existing treatments.
Additionally, Primoris Therapeutics has developed ExoPlus™, a superior exosome with enhanced cell growth, regeneration, and anti-inflammatory properties. To address production risks, such as quality control during late-stage clinical trials and commercialization, Kangstem Biotech's CMO(Contract Manufacturing Organization) has established a mass production process at a 100L scale.
Kyu-Heum Na, CEO of Primoris Therapeutics, commented, “If the Australian clinical trial meets US standards, the data could facilitate future global clinical trials in the US and Europe. We are also negotiating supply agreements with Korea’s largest burn hospital for future treatment development to capture the domestic market. We are committed to ensuring the safety and exploratory efficacy of PMS-101 in this Phase 1/2a trial and have set a clear strategy for advancing to further clinical stages and rapid commercialization.”