FromBio has initiated key non-clinical safety evaluations for its stem cell-based hair loss treatment.
The company announced on July 14 that it has signed a contract with the non-clinical testing organization Biotoxtech to conduct in vivo distribution and tumorigenicity tests related to its adipose-derived stem cell (dADSCs) hair loss treatment development. The results of these tests will serve as essential safety data for the upcoming submission of an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety.
The in vivo distribution evaluation checks the distribution and persistence of the administered cells, while the tumorigenicity test verifies the potential for tumor formation with long-term administration. Both tests are mandatory non-clinical evaluations in the development of cell therapies.
In addition to the safety evaluations, FromBio is also establishing a cell bank to ensure the quality uniformity and supply stability of the cells for clinical trials. This initiative aims to strengthen the manufacturing and quality control systems necessary for clinical development.
In previous general toxicity tests, no toxic effects were observed from the test substances. Furthermore, non-clinical efficacy evaluations using hair loss animal models confirmed the effects of promoting hair growth and increasing hair follicle generation, according to the company.
The dADSCs currently under development are candidate substances for cell therapy that utilize the company's proprietary differentiation technology. FromBio is progressing with non-clinical development, targeting an IND application next year.
CEO Shim Tae-jin stated, "The in vivo distribution and tumorigenicity tests are crucial steps for entering clinical trials. We will secure core safety data to complete non-clinical development and proceed with the IND application in 2027 without any setbacks."
Meanwhile, CEO Shim is enhancing responsible management by purchasing additional company shares. Following the acquisition of 130,000 shares on June 9, he bought another 150,000 shares on July 1, bringing the total to 280,000 shares. His ownership stake has increased from 36.06% to 37.04%.
The company explained that this purchase aims to convey the management's confidence in long-term growth amid challenging market conditions, including economic uncertainties and weakened consumer sentiment.
* This article has been translated by AI.
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