Transwell Biotech Co. Ltd. (TWB), a subsidiary of Easywell Biomedicals, Inc. (TWOTC: 1799),announces today that it has completed the safety evaluation of Phase I stage of its Phase I/II clinical trial with fetal skin cells to treat skin graft wounds of adults.
The Phase I/II clinical trial employs the study design of randomization, double-blind and placebo-control,to explore the safety and efficacy of using TWB-103 to treat adult patients with donor site wounds. In the Phase I stage, eligible subjects were randomized to receive study treatment that contains hydrogel with either live cells or placebo. Without un-blinding, safety data collected from a 28-day observational period was used to conduct a safety evaluation of Phase I stage.The safety data shows that there is no study treatment-related AE observed or clinically significant changes of values in various measures of laboratory tests and vital signs.All of the subjects have achieved 100% re-epithelialization of their donor site wounds within 2 weeks by receiving the study treatments of up to 7 days.
The principal investigator and the medical expert agree that TWB-103 shows no immediate safety concern with the available Phase I safety data. Based on the consensus,TWB decides to proceed to the Phase II stage of the present clinical trial in one study site (Tri-Services General Hospital) in Taiwan and two study sites (Tokyo Medical University Hospital and Nippon Medical School Hospital) in Japan.
TWB-103 is a novel allogenic regenerative medicine product designed and developed by TWB.TWB-103 combines cryopreserved cells derived from fetal skin cells with proprietary hydrogel that enables off-the-shelf use of the medicine.The pre-clinical and clinical data collected so far suggests therapeutic potential of TWB-103 in treating various acute and chronic wounds.
Transwell was established in 2010 and registered in Hsinchu, Taiwan. Possessing several platform technologies and cell processing techniques,Transwell is capable of designing and developing various cell-containing products. TWB-103 is the first therapeutic pipeline of Transwell undergoing clinical development.Transwell is continuously expanding its product and business spectrum through global partnership.
Easywell is listed in Taiwan OTC stock market. Business units of medical devices, pharmaceutics, and regenerative medicine, are continuously growing through several subsidiaries and offices of Easywell located in Taiwan, China, and the U.S.
Easywell Biomedicals, Inc.