Sirnaomics Ltd. (the “Company” or “Sirnaomics“, stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that the Company has received regulatory clearance from the Taiwan Ministry of Health and Welfare (TMHW) of its Investigational New Drug (IND) application to commence a Phase I trial of STP705, siRNA (small interfering RNA) drug candidate, for the treatment of patients with advanced liver tumors.
The Phase I multicenter, open-Label, dose escalation study in Taiwan is part of a global study of STP705 designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity. STP705 is administered intratumorally for cholangiocarcinoma, hepatocellular carcinoma, or liver metastases in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy. The study was started in the United States in March 2021, and the study in Taiwan is expected to begin enrolling in the coming months.
“The IND green light in Taiwan for STP705 represents a major milestone for the Company’s expansion of its clinical studies into Asia,” said Dr. Patrick Lu, founder, chairman of the Board, Executive Director, President and CEO of Sirnaomics. “We believe that the study results in Taiwan will strengthen the body of data in a multicenter global trial, which will also include a future study in the mainland China. Sirnaomics is currently in a strong position to lead the way in RNAi therapeutics for the development of novel oncology therapies.”
“This IND approval will allow more opportunities to manage critical diseases such as liver cancer with high unmet clinical need in Taiwan and the region,” stated Steven Long, Ph.D. Sirnaomics Chief Development Officer. “Taiwan’s regulatory bodies and clinical testing hospitals are well known for meeting international standards. We expect to conduct more oncology clinical studies in Asia-Pacific regions in the coming years.”
