Rion Co., Ltd. ((JP:6823)) announced an update on their ongoing clinical study.
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Rion Co., Ltd. (JP:6823) is spearheading a clinical study titled ‘An Adaptive Two-Part, Phase 1/2, Multi-Center, Double-Blinded, Randomized, Controlled Study of the Safety and Efficacy of Topically Applied PEP-TISSEEL in Participants With Chronic Radiation Ulcer.’ This study aims to evaluate the safety, tolerability, and efficacy of PEP-TISSEEL, a combination of Purified Exosome Product (PEP™) and Fibrin Sealant (TISSEEL®), in treating chronic radiation ulcers. The study’s significance lies in its potential to offer a new treatment avenue for patients suffering from this condition.
The intervention being tested is PEP-TISSEEL, a combination product designed to treat chronic radiation ulcers by promoting healing and tissue regeneration. The study compares this combination product against a placebo comparator, TISSEEL-Only, to assess its effectiveness and safety.
The study employs a randomized, parallel intervention model with a quadruple masking approach, meaning participants, care providers, investigators, and outcomes assessors are blinded in Phase 2. The primary purpose of the study is treatment-focused, aiming to establish the therapeutic potential of PEP-TISSEEL.
The study is set to begin on January 16, 2025, with its primary completion and estimated completion dates yet to be determined. The last update was submitted on April 4, 2025. These dates are crucial as they mark the progression and timeline of the study, which investors will closely monitor for developments.
This clinical study update could significantly impact Rion Co., Ltd.’s stock performance and investor sentiment. A successful outcome may enhance the company’s market position, especially in the biopharmaceutical sector, potentially leading to increased investor interest. Competitors in the wound care and regenerative medicine space will also be watching closely, as the results could shift market dynamics.
The study is ongoing, with further details available on the ClinicalTrials portal.