
RNA Interference New Drug Developer
Sirnaomics-B(02257) announced that its wholly-owned subsidiary, Sirnaomics, Inc., has completed the Phase I trial of the experimental drug STP707 and has officially submitted the clinical study report to the U.S. Food and Drug Administration (FDA).
The study enrolled adults with advanced, metastatic, or inoperable solid tumors that have spread or cannot be surgically removed and whose cancers have stopped responding to standard treatments. STP707 demonstrated definitive clinical activity in these patients, with some achieving disease stabilization and delayed disease progression in a population with limited treatment options and multiple prior lines of therapy. These patients received various doses of STP707 via intravenous administration. The conclusion at this early stage is that STP707 can be administered at multiple dose levels with mostly manageable side effects.
The company believes that completing the Phase I trial and submitting the clinical study report to the FDA is a key milestone for STP707. With the submission of the clinical study report, Sirnaomics, Inc. is preparing to initiate discussions with the FDA based on the completion of the STP707 Phase I trial submission to determine the Phase II development strategy.