On February 28, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in the brain cancer space, reported that the Company has completed and closed its Phase I clinical trial evaluating safety and tolerance for Pritumumab ("PTB") as a treatment for Primary and Metastatic Brain Cancers (Press release, Nascent Biotech, FEB 28, 2023, View Source [SID1234627926]). Previous announcements shared the end of the enrollment and dosing period of the Phase I trial.
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Nascent will continue to collect and evaluate the Clinical data from the Phase I trial as it prepares to submit results to the U.S. FDA for Phase II consideration.
Completing the Phase I trial is a major milestone and Nascent is excited to move toward finalizing plans for Phase II research. Phase I reinforced the companies’ determination and excitement around this unique monoclonal antibody treatment approach and Phase I has shown that it can be given safely at high doses. This is a new pathway toward attacking one of the defining health challenges we face, with longer-term implications that transcend the brain cancer market. We look forward to the opportunity to see our unique R&D platform become a game changer for patients suffering from brain cancer.
PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy and seek out only cancer cells without damaging healthy cells.