Any breach in skin integrity results in wounds, which may lead to the disruption of one or more functions as well as pain, discomfort and possible infection. It is usual to use skin grafts to treat wounds while wounds are extensive, unsuitable for closure by suturing, or are likely to cause physical or psychological problems through scarring. Split-thickness skin grafting is the most frequently used reconstructive technique to repair wounds caused by various acute and chronic situations. The wound created after harvesting the skin is called the donor site wound (DSW).

It is suggested that TWB-103 can serve as a “stimulus” or “aid” to wound healing process (i.e. hemostasis, inflammation, proliferation, and remodeling) through the production of cytokines and growth factors by the live cells. Additionally, TWB-103 provides wound site a number of matrix proteins that may play key structural roles in skin healing.

Transwell Biotech has received IND approval from Taiwan’s TFDA and Japan’s PMDA in 2017 for conducting a Phase I/II clinical study: “TWB-103 for Adult Patients with Split-Thickness Skin Graft Donor Site Wounds” in Taiwan and Japan. This is the first clinical trial employing TWB-103 as the investigational product.

The Phase I section of this clinical trial has started recruiting study subject in Taiwan since July 2017. The subject recruitment and treatment have been completed in December 2017. In order to proceed to the Phase II section of the clinical trial, a “Safety Evaluation” has been conducted and reported for the Phase I section. The report indicates that there is no immediate safety concern of administering TWB-103 on study subjects.

The Phase II section has started recruiting study subjects in 3 study sites (one in Taiwan and two in Japan) since January 2018. It is expected to complete subject recruitment and treatment at the end of 2018.