SIRNAOMICS-B (02257) announced that its wholly-owned subsidiary, Sirnaomics, Inc., has completed the Phase I trial of investigational drug STP707 and formally 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 had spread or could not be surgically removed and whose cancers had stopped responding to standard treatments. STP707 demonstrated clear clinical activity in these patients, with some achieving disease stabilization and delayed progression in a population with limited treatment options and extensive prior therapy. Patients received varying doses of STP707 via intravenous administration. Early-stage findings indicate that STP707 can be administered at multiple dose levels, with mostly manageable side effects. The company considers the completion of the Phase I trial and submission of the clinical study report to the FDA as a key milestone for STP707. Following the submission, Sirnaomics, Inc. plans to initiate discussions with the FDA to determine the Phase II development strategy based on the completed Phase I trial data.
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