Oncotelic Therapeutics (OTCQB: OTLC) and its 45%-owned subsidiary, Sapu Nano (US) LLC, announced that the independent Safety Review Committee has completed its review of the initial three-patient safety cohort in the ongoing Phase 1b SP-03-B101 trial of Sapu003, finding no dose-limiting toxicities and recommending advancement to the next planned dose level. The company also announced plans to expand the study into Europe with additional clinical sites to broaden patient access and support enrollment.
Oncotelic said the clinical milestone follows the publication of peer-reviewed research describing the scientific foundation of the Deciparticle(TM) nanomedicine platform and the intravenous everolimus formulation Sapu003. The company said the publication supports the platform’s scalable manufacturing capabilities, stability and preclinical antitumor activity while reinforcing the ongoing clinical development program.
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